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EXPLANATORY MEMORANDUM
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
Council Directive 1999/105/EC sets out rules on the production and marketing of
forest reproductive material (‘FRM Directive’). That Directive regulates forest
reproductive material (‘FRM’) which is important for forestry purposes.
In the years since its adoption, several important developments have taken place, and
most importantly:
– the adoption of the European Green Deal1
, which includes European Climate
Law2
, the new EU Strategy on Adaptation to Climate Change3
, the New EU
Forest Strategy for 20304
and the EU Biodiversity Strategy for 20305
, and
– the update of the Rules and Regulations of the Organisation for Economic Cooperation and Development (OECD) Scheme for the Certification of Forest
Reproductive Material Moving in International Trade6
(‘OECD Forest Seed
and Plant Scheme’).
In the light of those developments, the new policy priorities of the EU in relation to
sustainability, climate change adaptation and biodiversity, as well as the experience
gained during the implementation of Directive 1999/105/EC, it is appropriate to
revise this part of the EU legislation on the production and marketing of forest
reproductive material.
FRM refers to seeds, parts of plants and plants and is used for the creation of new
forests (‘afforestation’), the replanting of areas with trees (‘reforestation’) and other
types of tree planting for different purposes: (i) wood and biomaterials production,
(ii) biodiversity conservation, (iii) restoration of forest ecosystems, (iv) climate
adaptation, (v) climate mitigation and (vi) conservation and sustainable use of forest
genetic resources.
Seeds of agricultural crops are produced, certified, and harvested in cycles of one
year, while in the case of FRM it may take 50-100 years before seeds and forest
plants can be harvested from basic material. Because of these long production cycles,
it is essential to produce high-quality FRM and ensure traceability to (i) the original
-------------------------
1 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions - The European
Green Deal (COM(2019)640 final).
2 Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing
the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU)
2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1).
3 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, Forging a climate resilient Europe - the new EU Strategy on Adaptation to Climate Change (COM(2021) 82 final).
4 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, New EU Forest
Strategy for 2030 (COM(2021) 572 final).
5 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity
Strategy for 2030 Bringing nature back into our lives (COM(2020) 380 final).
6 Decision of the Council Establishing the OECD Scheme for the Certification of Forest Reproductive
Material Moving in International Trade [OECD/LEGAL/0355].
Pag. 2
parent trees from which that FRM has been harvested and (ii) the climatic and
ecological conditions under which those parent trees were grown. The process that
leads to the production and marketing of FRM is described hereafter.
FRM is harvested from parent trees (i.e. basic material). That basic material has been
selected for a number of superior characteristics (e.g. morphological features, wood
quality, health, and resistance) in view of the intended purpose for which the FRM will be used. The competent authorities of the Member States conduct an official
inspection to approve that basic material. Basic material is registered in a national
register with a unique register reference and with a so-called unit approval that
delineates the area from which FRM can subsequently be harvested. Upon the
harvesting of FRM a master certificate is issued. The master certificate serves to
ensure traceability of the FRM to the location of the basic material from which it has
been harvested. FRM has to comply with a number of quality requirements in order
to be certified. In the case of seeds those quality requirements relate to the purity of
the seeds and the number of viable seeds that can germinate (i.e. germination
percentage). The official label is issued following an official inspection by the
competent authorities which confirms that the FRM complies with the quality
requirements that have been laid down for the category of FRM concerned.
FRM production in the different Member States is oriented depending on the specific
needs. In certain Member States the timber and pulp industry are the most important
economic activity and hence wood production is the main branch of the FRM policy.
When selecting the ‘parent trees’ (i.e. basic material) from which FRM will be
harvested, wood quality will be the most important selection criterion in those
Member States.
In other Member States, FRM is produced to serve several purposes and create
multifunctional ecosystems. Certain parts of the forests are accessible to humans and
animals and fulfil social and cultural functions, while other parts of the forest are
protected by fences with the aim of biodiversity conservation and conservation of
forest genetic resources. In this case, a wide range of ‘parent trees’ with different
characteristics will be selected (small versus big trees, diverse sizes of branches) to
obtain a high degree of variation between those parent trees and ensure a high level
of genetic diversity. A high level of genetic diversity of the FRM that will be
harvested from those parent trees is also very important for climate adaptation as that
FRM could be planted in areas that are climatically suitable or may in the future
become climatically suitable for that FRM. This is the suitability of FRM for current
and projected future climatic conditions.
The current legislation defines FRM in relation to its importance for forestry
purposes in all or part of the Union, but it remains vague about the forestry purposes
that are covered by the scope of the legislation. This lack of clarity has in certain
cases led to situations where low-quality FRM has been planted. The planted trees
may initially grow well but fail to produce seeds 10-20 years after having been
planted. This may in the long-term lead to economic losses for the timber and pulp
industry. In the worst-case scenario it could lead to failure of forest ecosystems
because forests are more vulnerable to drought, pest attacks and other disturbances. It
is therefore necessary to clarify the scope of the EU legislation by listing the
purposes for which it is important to use high-quality FRM in the proposed
Regulation.
Pag. 3
Forests provide the raw material (wood and non-wood such as food and medical
plants) for growing bioeconomy value chains substituting fossil-based or otherwise
harmful products. Through the purpose of the production of wood and biomaterials,
the proposed Regulation supports the extended forest-based value chains which
currently count 4,5 million jobs in the EU7
.
As already mentioned above, it should furthermore be ensured that Member States
can produce FRM for the purposes that are relevant in their territory. Member States
must be thus allowed to decide on the selection criteria that will be applied to the
basic material in view of the intended purpose of that FRM. Moreover, the planting
of high-quality FRM in area with favourable climatic and ecological conditions
contributes to achieving the intended purpose of that FRM.
For example, FRM can be harvested from basic material that has been assessed and
approved for the purpose of wood production. If such FRM is planted under
favourable conditions, it will produce a higher volume of wood compared to the
average wood production of FRM that is not planted under favourable conditions.
Likewise, FRM can be harvested from basic material that has been selected and
assessed for its adaptation to the local and regional climatic and ecological
conditions with respect to the biotic and abiotic factors in that area. Such FRM
planted under favourable conditions for the purpose of climate adaptation will
contribute to the resilience of forests to extreme weather and their adaptation to
changing climatic conditions. Forested land is, by far, the main contributor to the EU
carbon sink and will play an essential role in meeting the EU’s ambitious objective
of climate neutrality by 2050.
The proposed Regulation is replacing Directive 1999/105/EC, clarifying its scope
and updating its provisions.
It has the following general objectives:
(a) To ensure a level playing field for operators across the EU;
(b) To support innovation and competitiveness of the EU FRM industry;
(c) To contribute to addressing sustainability, biodiversity and climate-related
challenges.
It has the following specific objectives:
(a) To increase clarity and coherence of the legal framework through simplified,
clarified and harmonised basic rules on fundamental principles presented in a
modern legal form;
(b) To enable the uptake of new scientific and technical developments (in
particular, innovative production processes, bio-molecular techniques and
digital solutions);
(c) To ensure availability of FRM suitable for future challenges;
(d) To support the conservation and sustainable use of forest genetic resources.
(e) To harmonise the framework for official controls on FRM;
(f) To improve coherence of FRM legislation with the Plant health legislation.
---------------------------
7 Robert N., Jonsson R., Chudy R., Camia A. (2020) The EU Bioeconomy: Supporting an Employment
Shift Downstream in the Wood-Based Value Chains? Sustainability 12, 758.
Pag. 4
The proposed Regulation is part of the Regulatory Fitness Programme (REFIT).
• Consistency with existing policy provisions in the policy area
The proposed Regulation has links to EU policies on plant health (Regulation (EU)
2016/2031 of the European Parliament and of the Council8
) and official controls
(Regulation (EU) 2017/625 of the European Parliament and of the Council9
).
The rules in Regulation (EU) 2016/2031 concerning pests will also apply to the
production and marketing of FRM. The official label for FRM will be combined with
the plant passport established by that Regulation.
The FRM rules will be included in the scope of Regulation (EU) 2017/625
concerning official controls. This will ensure consistency with the other EU acts
concerning the production and marketing of plants (Regulation (EU) 2016/2031 and
the proposed Regulation on the production and marketing of plant reproductive
material), which are also part of the EU legal regime of official controls.
• Consistency with other EU policies
The forestry policy in the EU values the central and multi-functional role of forests
and forest ecosystems and recognises that forests are under increasing pressure,
caused by extreme weather events, pests and diseases as a result of the climate
change. Increasing disturbance frequency and intensity, for example by bark beetle
outbreaks, results in greenhouse gas emissions, biodiversity loss and economic loss.
They may also cause abrupt increases of salvage logging with a direct impact on the
market across countries.
The proposed Regulation contributes to the overall policies of the European Green
Deal and related legislation and strategies: the European Climate Law, the new EU
Strategy on adaptation to climate change, the New EU Forest Strategy for 2030 and
the EU Biodiversity Strategy for 2030.
The proposed Regulation will help achieve the objectives of the European Climate
Law and the EU Adaptation Strategy by facilitating the planting of the right tree in
the right place. This will create significant benefits for foresters, the forest
bioeconomy and the society as a whole.
The requirement for Member States to prepare national contingency plans will ensure
a sufficient supply of FRM to reforest areas affected by extreme weather events,
wildfires, disease and pest outbreaks, disasters or any other event. The contingency
--------------------------
8 Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on
protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No
652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council
Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC
(OJ L 317, 23.11.2016, p. 4).
9 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official
controls and other official activities performed to ensure the application of food and feed law, rules on
animal health and welfare, plant health and plant protection products, amending Regulations (EC) No
999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No
652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council
Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC,
2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC)
No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC,
89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision
92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
Pag. 5
plans policy reflects the general preparedness actions that Member States should take
under the Union Civil Protection Mechanism including the conduct of national risk
assessments10
.
The proposed Regulation aims to contribute to the objectives of the New EU Forest
Strategy for adapting forests to climate change and restoring forests affected by
climate-related damage, by introducing measures promoting the production of FRM
suitable for future climatic conditions. Through the establishment of national
contingency plans and the planting of the right tree in the right place this Regulation
helps ensure that future generations will continue to be able to enjoy the social and
cultural functions of forests.
The proposed Regulation will help conserve forest genetic resources and enhance
biodiversity, by facilitating the placing on the market of FRM intended for the
conservation and sustainable use of forest genetic resources.
Finally, the proposed Regulation creates the framework for introducing digital
technologies, to record all certification activities in an on-line platform in accordance
with the objectives of the European Digital Strategy11
.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
The proposal introduces rules necessary for the pursuit of the objectives of the
common agricultural policy, in the sector of the production and marketing of FRM in
the EU.
In this respect, the following two legal bases have been selected:
– Article 43(2) of the Treaty on the Functioning of the European Union (TFEU),
which provides the legal basis for adopting the provisions necessary for the
pursuit of the objectives of the common agricultural policy.
• Subsidiarity (for non-exclusive competence)
According to Article 4(2), point (d),) TFEU shared competence between the EU and
the Member States applies in the area of agriculture and fisheries, excluding the
conservation of marine biological resources.
Since the adoption of Directive 1999/105/EC, all fields of marketing of FRM have
been regulated at EU level to a very large extent. This has been a major contributor
to the establishment of an internal market in FRM. The impact assessments carried
out in 2013 and 2023 confirmed that the EU rules in place on the marketing of FRM
have had a generally positive impact on the free movement, the availability and
quality of FRM on the EU market and have thus facilitated trade within the EU. A
more harmonised approach with regard to the production and marketing of FRM,
cannot be sufficiently achieved at Member State level, because of the complexity,
and the international character. The response to the cross-border challenges in
relation to climate change, biodiversity and sustainability would be better achieved at
----------------------------
10 Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a
Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
11 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, 2030 Digital
Compass: the European way for the Digital Decade (COM(2021)118 final).
Pag. 6
EU level. The EU may therefore adopt measures regarding the production and
marketing of high-quality FRM that is suitable for climatic and ecological
conditions, in accordance with the principle of subsidiarity as set out in Article 5 of
the Treaty on European Union.
• Proportionality
As discussed in Chapter 7.4 of the impact assessment accompanying this proposal,
the measures proposed are limited to actions that need to be taken at EU level in
order to be effective and efficient. To achieve these needs, Directive 1999/105/EC
will be replaced by a Regulation on FRM. This type of instrument is considered most
suitable, considering that a key element of the proposal is to establish more
harmonised measures for Member States.
Uniform requirements for the production and marketing of FRM are the only way to
(i) ensure that FRM has a high level of quality for users, that the internal market
functions well and that there is a level playing field for the operators, (iii) ensure
sustainable afforestation and reforestation, biodiversity conservation and restoration
of forest ecosystems, and to (iv) support wood and biomaterials production, climate
adaptation, climate mitigation and the conservation and sustainable use of forest
genetic resources. To adapt the technical requirements to climatic and ecological
conditions Member States may, under certain conditions, lay down more stringent
national requirements. Moreover, for the registration of basic material and FRM
certification, flexibility and harmonisation are balanced with the flexibility for
Member States to implement those rules in a way that is adapted to their local
climatic and ecological conditions. The legislation also contains measures to
strengthen sustainability and respond to the call to adapt to climate change.
• Choice of instrument
The proposal takes the form of a Regulation of the European Parliament and of the
Council. Other means would not be appropriate because the objectives can be
achieved most efficiently by fully harmonised requirements throughout the EU,
ensuring free movement of FRM.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER
CONSULTATIONS AND IMPACT ASSESSMENTS
• Ex-post evaluations/fitness checks of existing legislation
In 2019, the Council12 asked the Commission to present a study on the Union’s
options to update the existing legislation on the production and marketing of plant
reproductive material (‘PRM study’)13
. That study was supported by an external data
-------------------------------
12 Council Decision (EU) 2019/1905 of 8 November 2019 requesting the Commission to submit a study
on the Union’s options to update the existing legislation on the production and marketing of plant
reproductive material, and a proposal, if appropriate in view of the outcomes of the study (OJ L 293,
14.11.2019, p. 105).
13 Commission Staff Working Document Study on the Union’s options to update the existing legislation
on the production and marketing of plant reproductive material (SWD(2021)90 final).
Pag. 7
gathering study14
. The PRM study identified 5 key problems with the existing
legislation.
These concerned:
(1) the non-harmonised implementation of the legislation causing a non-level
playing field for operators;
(2) complex and rigid procedures, creating a cumbersome decision-making
process;
(3) the rigidity of the legal framework posing difficulties to address policy issues
identified in the European Green Deal and its related strategies;
(4) the lack of a harmonised and risk-based framework for official controls,
causing a non-level playing field for official controls;
(5) the lack of provisions in the legal framework to take account of scientific and
technological progress.
The 2019 Council request contained a revision clause that provided the Commission
with a mandate to present a legislative proposal, if appropriate in view of the
outcome of the aforementioned study.
• Stakeholder consultations
The impact assessment accompanying the Regulation on FRM involved a wide range
of consultations addressing all types of stakeholders comprising an inception impact
assessment, a public consultation, working groups with competent authorities and
stakeholders and bilateral meetings with stakeholder organisations.
● There were 66 responses to the consultation on the inception impact
assessment from 16 countries and 2449 responses to the public consultation
from 29 countries;
● Thirty-nine respondents to the inception impact assessment and 181
respondents to the public consultation submitted a position paper;
● There were targeted consultations to gather more specialised feedback from
competent authorities and SMEs that resulted in 25 and 251 responses,
respectively;
● A targeted survey carried out by an external consultant supporting the
Commission’s impact assessment returned 99 responses;
● The consultant furthermore conducted 13 in-depth interviews and organised a
focus group containing 4 participants.
There was overall support for keeping the FRM legislation separated from the
legislation on other PRM. All respondents called for the existing pillars of
registration of basic material and FRM certification to be retained. The majority of
respondents highlighted the necessity of retaining flexibility to allow Member States
to decide which FRM is adapted to their local and regional climatic and ecological
conditions.
-----------------------------
14 ICF (2021) Data gathering and analysis to support a Commission study on the Union’s options to
update the existing legislation on the production and marketing of plant reproductive material;
https://doi.org/10.2875/406165.
Pag. 8
Because the scope of the Directive 1999/105/EC is vague about the purposes that are
covered, Member States have had different interpretations and understanding of what
is included in the scope of Directive 1999/105/EC. For example, agroforestry is
considered within the scope of the Directive in some Member States but not in
others. As a result, in those Member States where agroforestry is considered outside
the scope of Directive 1999/105/EC, FRM from regulated species can be sold for
agroforestry purposes without the approval of basic material. Respondents to the
stakeholder consultations expressed mixed views as regards the purposes that should
be covered by the scope of the FRM legislation.
Most operators agreed that aligning the requirements for official controls is desirable.
Most stakeholders opposed to include the FRM legislation in the scope of the
Official Controls Regulation because of the specificity of official controls in this
sector, and called for official controls, to remain under the control of the respective
competent forest authority. However, it is expected that the benefits of inserting the
FRM legislation into the scope of the OCR will outweigh the disadvantages.
Stakeholders also were concerned about the potential increase in administrative
burden. Most stakeholders called for some flexibility to be maintained in the
organisation of official controls and for the costs to be kept as low as possible.
Most stakeholders agreed that the use of bio-molecular techniques and digital
solutions could bring benefits and called for the legal framework to allow the latest
technologies to be applied, in line also with developments in international standards.
Detailed information about the stakeholder consultations can be found in chapter
5.2.5 and Annex 2 of the impact assessment.
• Collection and use of expertise
An external consulting company contracted by the Commission conducted a study in
support of the impact assessment15. The company and its experts worked closely with
the relevant Commission departments during the various stages of the study.
The consultant gathered additional data and comments through desk research, a
targeted survey, a focus group and in-depth interviews with stakeholders. The
support study considered the problem definition, the case for EU action, the
objectives of policy intervention and the baseline scenario. It assessed the potential
impacts of three options, each including variations on up to 19 specific measures,
being proposed by the Commission.
The support study served to refine the policy options and select the preferred policy
option.
• Impact assessment
This proposal is based on an impact assessment which received a ‘positive opinion
with reservations’ from the Regulatory Scrutiny Board on 17 February 2023.
There are two main problems identified with the current FRM legal framework:
1. There is a non-harmonised internal market characterised by divergent
conditions for operators and marketed FRM across Member States. The
implementation of various aspects of the legislation differs between Member
-------------------------------------
15 ICF (2022) Study supporting the Impact Assessment for the revision of the plant and forest reproductive
material legislation; https://data.europa.eu/doi/10.2875/4381.
Pag. 9
States because (i) the legislation leaves room for interpretation, (ii) Member
States tried to find practical solutions to overcome rigid provisions and (iii) the
legislation has not followed new developments in science and technology in
good time.
2. The legislation is not aligned with the objectives of the European Green Deal
and the related strategies. There are restrictions in relation to the genetic
diversity of FRM, a lack of sustainability characteristics and the incomplete
scope of the FRM legislation. There is an insufficient supply of high-quality
certified FRM due to the increasing demand for FRM for reaching the EU
target of planting 3 billion additional trees by 2030 aiming to double the
number of trees planted per year and having in mind the purposes of wood and
biomaterials production, biodiversity conservation and restoration of forest
ecosystems. The increasing occurrence of extreme weather and disasters, in
combination with an insufficient assessment of sustainability characteristics for
the lower FRM categories, has put pressure on the supply of suitable FRM and
thus on the resilience of forest ecosystems.
The general objective of this initiative is to ensure, for all types of users, the
availability of FRM of high quality and diversity of choice, adapted to current and
projected future climatic conditions. At a next level, this will in turn help protect
biodiversity and restore forest ecosystems.
The impact assessment compiled all possible measures for analysis, based on (i) an
external data gathering study supporting a Commission study on the EU’s options to
update the legislation on PRM, (ii) a study in support of the impact assessment
conducted by an external consultant and (iii) the aforementioned stakeholder
consultation activities.
The diverse, complex and often interrelated measures were grouped under three
policy options, all of which are compared to a ‘no policy change’ scenario. Three
options were assessed. Option 1 offered the most flexibility while option 3 offered
the most harmonisation, so as to minimise differences in how the legislation is
implemented. Option 2 balanced the need for flexibility with a higher degree of
harmonisation to overcome the problems stemming from differences in
interpretation.
All options contained a number of common elements: (i) simplified administrative
procedures and a more flexible decision-making process and (ii) harmonisation with
the plant health legislation.
1. Option 1 - Highest level of flexibility: Option 1 would lay down minimum
requirements for FRM official controls, but without linking those to the
Official Controls Regulation. It would adopt guidelines on the use of
innovative production processes, bio-molecular techniques and digital
solutions. The FRM legislation would only cover production for ‘forestry
purposes’ to ensure the availability of high-quality FRM for
afforestation/reforestation. Sustainability requirements would be extended to
the lower FRM categories. Guidelines would be introduced on contingency
planning for major FRM shortages, in the event of extreme weather and
disasters.
2. Option 2 - Balancing flexibility and harmonisation (preferred option):
Option 2 would bring the official controls on FRM under the scope of the
Pag. 10
Official Controls Regulation, but with simplified import controls at appropriate
places within the EU, to ensure a more targeted and efficient enforcement of
the existing rules. Basic principles would be included in the legislation for the
use of innovative production processes, bio-molecular techniques and digital
solutions. The FRM legislation would cover production for ‘forestry’ and ‘nonforestry’ purposes, to increase FRM availability and quality beyond
afforestation/reforestation uses. Sustainability requirements would be extended
to the lower FRM categories. General legal requirements would be introduced
for contingency planning for major FRM shortages in the event of extreme
weather and disasters.
3. Option 3 – Highest level of harmonisation: Option 3 would bring the official
controls on FRM under the scope of the Official Controls Regulation, with
stricter import controls at border control posts, requiring special import
documentation to strengthen and fully harmonise enforcement. Detailed and
binding rules would be included in the legislation for the use of innovative
production processes, bio-molecular techniques and digital solutions. The FRM
legislation would cover production for ‘forestry’ and ‘non-forestry’ purposes to
increase FRM availability and quality beyond afforestation/reforestation uses.
Sustainability requirements would be extended to the lower FRM categories
and be subject to harmonised rules. Common rules would be introduced for
contingency planning to prepare for major FRM shortages in the event of
extreme weather and disasters.
Based on the outcome of the impact assessment, the Commission concluded that
policy option 2 is the best option to effectively address all the objectives of the
revision of FRM legislation in efficiently and consistently.
The preferred option will bring efficiency gains for operators and competent
authorities through (i) the possibility for operators to print the official label under
official supervision, (ii) harmonisation with the plant health legislation, (iii) the
introduction of risk-based official controls and the possibility to use bio-molecular
techniques and (iv) digital solutions in the registration and certification systems.
FRM with improved sustainability characteristics will contribute to the adaptation
and mitigation of the already visible impact of climate change on forests, therefore
delivering important environmental benefits. National contingency plans will ensure
a sufficient supply of FRM to reforest areas affected by extreme weather events,
wildfires, disease and pest outbreaks, or other disasters. The risk of planting low quality FRM will thus be reduced. Finally, benefits are expected for the conservation
and sustainable use of forest genetic resources through a specific derogation.
The proposed Regulation clarifies that FRM is used for afforestation, reforestation
and other types of tree planting for various purposes. As regards the scope of the
Regulation, it was considered most appropriate that it explicitly covers the purposes
for which it is deemed important to use high-quality FRM. This is necessary in order
to ensure that only the most suitable FRM for those purposes is used and to avoid
economic losses and environmental damages caused by the use of low-quality FRM.
• Regulatory fitness and simplification
The proposal introduces a simpler and less burdensome regulatory regime for FRM
serving the purposes of conservation of genetic resources and their sustainable use,
by replacing the approval procedure of basic material that is intended for the
production of such FRM by a notification procedure.
Pag. 11
It will enable professional operators to print the official label under official
supervision by the competent authorities, if they so wish once the competent
authorities have concluded that the FRM is certified. Several processes will be
simplified. Those simplification measures, benefit both SMEs and micro-enterprises.
Finally, the proposal introduces new features concerning the digitalisation of the
FRM sector.
• Fundamental rights
The proposed regulation respects all provisions of the Charter of Fundamental Rights
of the European Union, and especially by setting out rules aiming at freedom to
conduct business, avoidance of discrimination, and consumer and environmental
protection.
4. BUDGETARY IMPLICATIONS
There are no budgetary implications.
5. OTHER ELEMENTS
• Implementation plans and monitoring, evaluation and reporting arrangements
By the fifth year after the date of application of this Regulation, and every five years
thereafter, Member States are required to submit a report to the Commission on
several aspects of the use of derogations and policies aiming to conservation of
genetic resources, agro-biodiversity and simplified procedues for small producers.
This is necessary in order to review the effectiveness of those new policies and
examine whether improvements would be needed. Specifically, these concern
reporting on the following elements:
● the annual quantities of certified FRM;
● the adopted national contingency plans;
● the information available to users on where to best plant FRM, on websites
and/or in planters’ guides;
● the number of FRM entries containing information on the suitability of FRM
for climatic and ecological conditions;
● the number of FRM notifications for the purpose of conserving forest genetic
resources;
● the quantities of imported FRM;
● the penalties imposed.
• Detailed explanation of the specific provisions of the proposal
(i) Scope
The proposed Regulation applies to FRM of species and artificial hybrids,
which is used in afforestation, reforestation and other types of tree planting for
the purposes of wood and biomaterials production, biodiversity conservation,
restoration of forest ecosystems, climate adaptation, climate mitigation, and
conservation and sustainable use of forest genetic resources.
(ii) Basic material and categories
Pag. 12
Only basic material approved by the competent authorities may be used to
produce and market FRM. For the same reason, only FRM derived from such
basic material may be placed on the market.
The following 6 types of basic material, from which FRM could be harvested,
are kept as they appear in Directive 1999/105/EC: seed source, stand, seed
orchard, parents of family(ies), clone and clonal mixture.
The competent authorities will assess the sustainability characteristics of basic
material during the procedure for approving that basic material. The
characteristics concern the adaptation of the basic material to the local climatic
and ecological conditions and the freedom of trees from pests and their
symptoms.
The procedure for approving basic material will include the use of biomolecular techniques as a complementary method, and innovative clonal FRM
production techniques.
After FRM is harvested, a master certificate will be issued by the competent
authorities for all FRM derived from approved basic material. This certificate
ensures that the FRM is identifiable, that it carries information about the origin
of the basic material from which it has been harvested, and provides the most
appropriate data for its users and the competent authorities responsible for its
official controls. The master certificate may also be issued in electronic form.
FRM is to be certified as ‘source-identified’, ‘selected’, ‘qualified’ and ‘tested’
by the competent authorities, and marketed with a reference to those
categories, in order to adapt to the respective standards of the OECD Forest
Seed and Plant Scheme. Specific rules for the approval of basic material are set
out for each category, which are largely identical to the ones established by
Directive 1999/105/EC.
In the case of basic material intended for producing FRM in the ‘source identified’ and ‘selected’ categories, the Member States will, for the relevant
species, demarcate the regions of provenance, in order to identify an area or
groups of areas with sufficiently uniform ecological conditions and containing
basic material with similar phenotypic or genetic characteritsics.
This is necessary because the FRM produced from that basic material will be
marketed with reference to those regions of provenance.
(iii) Professional operators.
Professional operators may be authorised by the competent authority to print,
under official supervision, the official label for certain species and categories
of FRM. Rules are set out withdrawing or modifying that authorisation, to
make sure the system functions effectively.
They will be registered in accordance with Regulation (EU) 2016/2031 of the
European Parliament and of the Council. This is necessary for the efficiency
and avoidance of double registration, because the professional operators
covered by this Regulation coincide to a great extent with the ones covered by
the scope of Regulation (EU) 2016/2031.
Before purchasing FRM, professional operators will make available to the
potential buyers of their FRM all necessary information concerning its
suitability for climatic and ecological conditions.
Pag. 13
(iv) Registers of FRM and contingency plans
Each Member State will establish, publish and keep updated, in electronic
format, (i) a national register of the basic material for the various species and
artificial hybrids approved on its territory, and (ii) a national list, which should
be presented as a summary of the national register. The national list should be
presented in a common form for each unit of approval. It will contain
information on the botanical name, category of FRM, purpose, basic material,
register reference, location, altitude or altitudinal range, area, origin and in the
case of FRM of the ‘tested’ category, whether it is genetically modified or has
been produced by certain new genomic techniques16
.
For the same reason, the Commission should publish in electronic format a
Union list of approved basic material for producing FRM, on the basis of the
national lists provided by each Member State. That Union list is referred to as
the Commission’s Forest Reproductive Material Information System
(‘FOREMATIS’).
Each Member State must draw up and keep up to date a contingency plan to
ensure a sufficient supply of FRM to reforest areas affected by extreme
weather events, wildfires, disease and pest outbreaks, or other disasters
(v) Handling requirements and digitalisation
FRM will be kept separate by reference to individual units of approval and will
be produced and marketed in lots.
Seeds will be marketed only if they conform to certain quality standards. They
will be labelled and marketed only in sealed packages.
The proposed Regulation will meet the aim of the EU Digital Strategy to make
the transformation to digital technologies work for people and businesses. It
should therefore contain an empowerment that will establish rules regarding (i)
the digital recording of all actions taken to issue the master certificate and the
official label, respectively, and (ii) the establishment of a centralised platform
facilitating the processing of, access to, and use of those records. In this
respect, the use of electronic labels should also be allowed.
(vi) Derogations and conservation purposes
During periods in which there are temporary difficulties in obtaining supplies
of certain species of FRM, basic material satisfying less stringent requirements
will be temporarily approved for the production of FRM belonging to the
species concerned.
Temporary experiments will be organised at EU level to seek improved
alternatives as regards provisions set out in this Regulation.
The requirements for basic material intended for the purpose of conservation
and sustainable use of forest genetic resources will be different from those for
basic material intended for producing FRM in the categories ‘source-
---------------------------------------
16 Regulation (EU) [Publications Office, please insert reference] of the European Parliament and of the
Council on plants obtained by certain new genomic techniques and their food and feed, and amending
Directives 68/193/EEC, 1999/105/EC, 2002/53/EC, 2002/55/EC, and Regulation (EU) 2017/625 (OJ L
…, …).
Pag. 14
identified’, ‘selected’, ‘qualified’ and ‘tested’. The objective being to help
increase diversity within a single tree species and respond to the decline in
biodiversity.
(vii) Imports
FRM will be imported from third countries only if it is established that it fulfils
requirements equivalent to those applicable to FRM produced and marketed in
the EU. This is necessary to ensure that such imported FRM offers the same
level of quality as the FRM produced in the EU.
The professional operators will inform the respective competent authority in
advance of the importation of seed, planting stock and other parts of plants,
through the information management system for official controls (IMSOC) set
up pursuant to Regulation (EU) 2017/625. Imported FRM will be accompanied
by a master certificate or an official certificate issued by the third country of
origin, and records containing details of that material, provided by the
professional operator in that third country. An official label will be attached to
that FRM.
The rules in Regulation (EU) 2016/2031 concerning pests will also apply to the
production and marketing of FRM under the proposed Regulation. The
proposed Regulation includes an amendment of Regulation (EU) 2016/2031,
introducing the possibility that the official label for FRM is combined with the
plant passport in a single format.
It further introduces an amendment to Regulation (EU) 2017/625 to include
FRM rules under the scope of the EU legislation on official controls. The basic
rules and principles of official controls will also apply for the production and
marketing of FRM, including the ones for the powers of authorities, delegation
of tasks, and certification. The Commission will be empowered to adopt
special rules for official controls on FRM marketing and professional
operators, as needed. In the case of imports, the general rules will apply on a
risk basis.
The proposed Regulation will apply 3 years after its entry into force, to offer
the appropriate time for the competent authorities and professional operators to
adapt to the new rules. It will also give the Commission time to adopt the
necessary delegated and implementing acts.
Pag. 15
2023/0228 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on the production and marketing of forest reproductive material, amending Regulations (EU) 2016/2031 and 2017/625 of the European Parliament and of the Council and repealing Council Directive 1999/105/EC (Regulation on forest reproductive material)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular
Article 43(2) thereof,
Having regard to the proposal from the European Commission1
,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee 2
,
[Having regard to the opinion of the Committee of the Regions,]
Acting in accordance with the ordinary legislative procedure3
,
Whereas:
(1) Council Directive 1999/105/EC4
sets out rules on the production and marketing of
forest reproductive material (‘FRM’).
(2) Forests cover some 45% of the land area in the Union and fulfil a multifunctional role
that comprises social, economic, environmental, ecological and cultural functions.
Forests have a premordial function as a carbon sink in the climate mitigation policy.
High-quality, climate-adapted and diverse FRM is essential to cover these needs.
(3) In the light of new technical and scientific developments, the update of the Rules and
Regulations of the Organisation for Economic Co-operation and Development
(OECD) Scheme for the Certification of Forest Reproductive Material Moving in
International Trade5
(‘OECD Forest Seed and Plant Scheme’), the new policy
priorities of the Union in relation to sustainability, climate change adaptation and
biodiversity and in particular the European Green Deal6
, as well as the experience
-------------------------------------
1 OJ C 199, 14.7.1999, p. 1.
2 OJ C 329, 17.11.1999, p. 15.
3 Position of the European Parliament of … and position of the Council at first reading of ... Position of
the European Parliament of ... and decision of the Council of ....
4 Council Directive 1999/105/EC of 22 December 1999 on the marketing of forest reproductive material
(OJ L 11, 15.1.2000, p. 17).
5 Decision of the Council Establishing the OECD Scheme for the Certification of Forest Reproductive
Material Moving in International Trade [OECD/LEGAL/0355].
6 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions - The European
Green Deal (COM/2019/640 final).
Pag. 16
gained during the implementation of Directive 1999/105/EC, that Directive should be
replaced by a new act. In order to ensure uniform application of the new rules
throughout the Union, the act should take the form of a Regulation.
(4) The aim of the OECD Forest Seed and Plant Scheme is to encourage the production
and use of seeds, parts of plants and plants that have been collected, processed and
marketed in a manner that ensures a high quality and availability of FRM. Due to the
length of forest cycles and the cost of plantations and long-term forest investment, it is
essential that foresters get fully reliable information on the origin and on the genetic
characteristics of the FRM they use in plantation. The OECD Forest Seed and Plant
Scheme meets that need by means of certification and traceability. It has a major role
in helping the world’s forests adapt to changing climatic conditions. Emphasis is
placed on preserving species diversity and ensuring high genetic diversity within
species and seed lots thereby enhancing the adaptive potential of FRM for the future
replanting of an area with trees (‘reforestation’) and the creation of new forests
(‘afforestation’). Reforestation may be required when parts of an existing forest have
been affected by extreme weather events, wildfires, outbreaks of disease and pest
outbreaks, or other disasters.
(5) The European Green Deal sets out the Commission’s commitment for tackling climate
change and environmentally-related challenges. It aims to transform the Union’s
economy for a sustainable future. The Union rules on the production and marketing of
FRM need to be in line with Regulation (EU) 2021/1119 of the European Parliament
and of the Council establishing the framework for achieving climate neutrality7
and
with the three implementing strategies of the European Green Deal: the new EU
Strategy on Adaptation to Climate Change8
, the new EU Forest Strategy for 20309
and
the EU Biodiversity Strategy for 203010
--------------------------------.
(6) Regulation (EU) 2021/1119 requires relevant Union institutions and Member States to
ensure continuous progress in enhancing adaptive capacity, strengthening resilience
and reducing vulnerability to climate change. One of the aims of the new EU Strategy
on Adaptation to Climate Change is therefore to accelerate the adaptative capacity of
the Union to climate change, by amending the rules on FRM, amongst others. The
Union legislation should encourage the Union wide production and marketing of
FRM. To this end, the possibility for Member States to restrict the approval of certain
basic material and to prohibit the marketing of certain FRM to final users, as it it set
out in Directive 1999/105/EC, should be abolished.
(7) The new EU Forest Strategy for 2030 has as its key objectives effective afforestation,
and forest preservation and restoration in the Union, to help increase the absorption of
CO2, reduce the incidence and extent of forest fires, and promote the bio-economy, in
7 Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing
the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU)
2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1).
8 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, Forging a climate resilient Europe - the new EU Strategy on Adaptation to Climate Change (COM(2021) 82 final).
9 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, New EU Forest
Strategy for 2030 (COM(2021) 572 final).
10 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity
Strategy for 2030 Bringing nature back into our lives (COM(2020) 380 final).
Pag. 17
full respect of ecological principles favourable to biodiversity. Ensuring forest
restoration and reinforced sustainable forest management are essential for climate
adaptation and forest resilience. In this regard, the new EU Forest Strategy states that
adapting forests to climate change and restoring forests following climate damages
will require large quantities of appropriate FRM. This implies efforts to secure and
sustainably use the forest genetic resources on which a more climate-proof forestry
depends. Efforts are also needed to increase the production and availability of such
FRM, to provide better information on its suitability for climatic and ecological
conditions and to enhance its collaborative production and transfer across national
borders within the Union. Professional operators should thus be required to provide
beforehand information to the users about the suitability of FRM for climatic and
ecological conditions.
(8) The EU Biodiversity Strategy for 2030 aims to put Union biodiversity on the path to
recovery by 2030. Within the framework of that strategy, Union legislation is to place
emphasis on the preservation of species diversity and ensure high genetic diversity
within species and seed lots. This aims to facilitate the supply of high-quality and
genetically diverse FRM that is adapted to current and projected future climatic
conditions. The conservation and improvement of biodiversity of forests, including the
genetic diversity of the trees, are essential to sustainable forest management and for
supporting forests’ adaptation to climate change. Tree species and artificial hybrids
under this Regulation should be genetically suited to the local conditions and be of
high quality.
(9) There is a long-term cross-border dimension due to the fact that the already observed
northward migration of vegetation zones is expected to accelerate significantly in the
coming decades. Hence the requirement in this Regulation for providing information
about the zones where seed can be planted or FRM is adapted to the local conditions
would be an extremely useful asset to foresters. Competent authorities should
therefore designate zones specifying that in these zones the seed is suited to the local
conditions and can be sown (‘seed transfer zones’). Likewise, they should designate
areas specifying that in these areas FRM is adapted to the local conditions
(‘deployment areas’).
(10) Directive 1999/105/EC defines FRM in relation to its importance for forestry purposes
in all or part of the Union but it remains vague about those forestry purposes. For the
sake of clarity, the scope of this Regulation lists the purposes for which it is important
to use high-quality FRM.
(11) FRM may be produced for use in afforestation/reforestation and other types of tree
planting and for several different purposes such as wood and biomaterials production,
biodiversity conservation, restoration of forest ecosystems, climate adaptation, climate
mitigation, and conservation and sustainable use of forest genetic resources.
(12) Research has shown that the assessment and approval of basic material in relation to
the specific purpose for which the FRM will be used are of utmost importance. In
addition to that, the planting of high-quality FRM at the right place has a positive
impact on the purpose for which that FRM is used. At the right place means that the
FRM is genetically and phenotypically suited to the site where it is grown, including
the relevant climate projections for it.
(13) In order to ensure a sufficient supply of FRM in response to the increased demand for
FRM, it is necessary to remove any actual or potential barriers to trade, which may
Pag. 18
hinder the free movement of FRM within the Union. This aim can be achieved only if
the respective Union rules on FRM impose the highest possible standards.
(14) The Union rules on the production and marketing of FRM should take into account
practical needs and should apply only to certain species and artificial hybrids which
are are listed in Annex I to this Regulation. Those species and artificial hybrids are
important for the production of FRM for afforestation, reforestation and other types of
tree planting for the purpose of wood and biomaterials production, biodiversity
conservation, restoration of forest ecosystems, climate adaptation, climate mitigation,
and conservation and sustainable use of forest genetic resources.
(15) The aim of this Regulation is to ensure the production and marketing of high-quality
FRM. To help create resilient forests and restore forest ecosystems, users should be
informed prior to the purchase of FRM about the suitability of that FRM for the
climatic and ecological conditions of the area where it will be used.
(16) To ensure that certified FRM will be adapted to the climatic and ecological conditions
of the area where it is planted, the competent authorities should assess the
sustainability characteristics of basic material during the procedure for approving that
basic material. Those sustainability characteristics should concern the adaptation of
that basic material to the climatic and ecological conditions and the freedom of trees
from pests and their symptoms.
(17) FRM should only be harvested from basic material that has been assessed and
approved by the competent authorities in order to ensure the highest possible quality
of that FRM. Approved basic material should registered in a national register with a
unique register reference and with reference to a unit of approval.
(18) In order to adapt to the scientific and technical developments of international
standards, the use of bio-molecular techniques should be included as a complementary
method in the procedure for the approval of basic material. Those bio-molecular
techniques should be allowed to assess the origin of basic material or to screen the
basic material for the presence of disease resistance traits through molecular markers.
(19) A master certificate should be issued by the competent authorities of the respective
Member States for all FRM that is derived (i.e. harvested) from approved basic
material. Such master certificate ensures the identification of the FRM, contains
information about its origin and provides the most appropriate details for its users and
the competent authorities in charge of its official control. It should be allowed to issue
the master certificate in an electronic form.
(20) Only FRM that has been harvested from approved basic material should be allowed to
be subsequently certified and placed on the market. FRM should be certified as
‘source-identified’, ‘selected’, ‘qualified’ and ‘tested’ by the competent authorities and
be marketed with a reference to those categories. Those types of categories show
which of the characteristics of the basic material have been assessed and they indicate
the quality of the FRM. For lower quality FRM (‘source-identified’ and ‘selected’
categories), basic material will be checked for basic characteristics. For higher quality
FRM (‘qualified’ and ‘tested’ categories), parent trees will be selected for outstanding
characteristics and crossing schemes designed. In the case of FRM of the ‘qualified’
category, the superiority of the FRM estimated on the basis of the characteristics of the
parent trees. In the case of the ‘tested’ category, the superiority of that FRM must be
demonstrated in comparison with either the basic material from which that FRM has
been harvested or with a reference population. The ‘source-identified’, ‘selected’,
Pag. 19
‘qualified’ and ‘tested’ categories of FRM should be subject to uniform production
and marketing requirements, to ensure transparency, equal terms of competition and
the integrity of the internal market.
(21) The certification rules should be clarified in the case of FRM that has been produced
through innovative production processes and in particular FRM production techniques
for the production of a specific type of FRM, namely clones. As the place of
production of those clones may be different from the location of the original tree (i.e.
basic material) from which the clone(s) has been derived, the rules should be amended
to guarantee traceability.
(22) The requirements for basic material intended for the purpose of conservation and
sustainable use of forest genetic resources are different from those for basic material
intended for the production of FRM for commercial purposes, because of the different
selection criteria applied for these two types of basic material. For the purpose of
conserving and sustainably using forest genetic resources, all trees from a stand of
trees in the forest should be kept. This is necessary to help increase the genetic
diversity within a single tree species. On the other hand, only trees with superior
characteristics should be selected in the case of basic material intended for the
production of FRM for commercial purposes. Member States should therefore be
allowed to derogate from the applicable rules as regards the approval of basic material
and notify this basic material intended for the purpose of conserving forest genetic
resources to the competent authority.
(23) The source-identified category is the minimum standard required for the marketing of
FRM, because little or no phenotypic selection of the basic material intended for the
production of FRM of the source-identified category has taken place. To ensure
traceability, the professional operator should record the location of the basic material
(i.e. provenance) from which FRM is collected. The origin of that basic material
should be stated if known. This is in line with the OECD Forest Seed and Plant
Scheme’ and the experience gained with Directive 1999/105/EC.
(24) Pursuant to the OECD Forest Seed and Plant Scheme and following the application of
Directive 1999/105/EC, the competent authority should assess basic material intended
for the production of FRM of the selected category based on the observation of the
characteristics of that basic material, taking account of the specific purpose for which
the FRM harvested from that basic material is to be used. The overall quality of that
category should be ensured. As the population should show a high degree of
uniformity, trees that have inferior characteristics (e.g. smaller size) in comparison to
the average tree size in the overall population should be removed.
(25) In order to produce FRM of the qualified category, the professional operator should
select the components of the basic material that will be used in the crossing design at
individual level due to their outstanding characteristics as regards, for example,
adaptation to the local climatic and ecological conditions. The competent authority
should approve the composition and proposed crossing design of those components,
the field layout, the isolation conditions and location of that basic material. This is
important in order to align with the applicable international standards pursuant to the
OECD Forest Seed and Plant Scheme Scheme’and to take into account the experience
gained from Directive 1999/105/EC.
(26) Basic material that is intended for the production of FRM of the tested category should
be subject to the most stringent possible requirements. Determining the superiority of
FRM should be made by comparing it with one or preferably several approved or pre
Pag. 20
EN
chosen standards. The professional operator selects those standards on the basis of the
purpose for which the FRM of the tested category will be used. In this regard, if the
purpose of that FRM will be climate adaptation, then the FRM will be compared with
standards having a good performance as regards adaptation to the local climatic and
ecological conditions (e.g. practical freedom from pests and their symptoms).
Following the selection of the components of basic material, the professional operator
should demonstrate the superiority of the FRM by comparative testing or estimate its
superiority by evaluating the genetic components of that basic material. The competent
authority should be involved in each step of this process. It should approve the
experimental design and tests for the aproval of the basic material, verify the records
provided by the professional operator and approve either the results of the tests
concerning the superiority of the FRM or the genetic evaluation as appropriate. This is
necessary, in order to align with the applicable international standards pursuant to the
OECD Forest Seed and Plant Scheme and other applicable international standards, and
to take into account the experience gained from Directive 1999/105/EC.
(27) The assessment of basic material intended for the production of FRM of the tested
category takes on average 10 years. In order to ensure faster market access of FRM of
the tested category, while the assessment of the basic material is still ongoing,
Member States should have the possibility to temporarily approve such basic material,
for a maximum period of 10 years, in all or part of their territory. That approval should
be granted only if the provisional results of the genetic evaluation or comparative tests
indicate that that basic material will satisfy the requirements of this Regulation when
the tests will be completed. This early assessment should be re-examined at a
maximum interval of ten years.
(28) Compliance of FRM with the requirements for the categories ‘source-identified’,
‘selected’, ‘qualified’ and ‘tested’ should be confirmed by inspections carried out by
the competent authorities as appropriate for each category (‘official certification’) and
should be attested by an official label.
(29) Genetically modified FRM may only be placed on the market if it is safe for human
health and the environment and has been authorised for cultivation pursuant to
Directive 2001/18/EC of the European Parliament and of the Council11 or Regulation
(EC) 1829/2003
12 and if that FRM belongs to the tested category. FRM obtained by
certain new genomic techniques may only be placed on the market if it complies with
the requirements of Regulation (EU) [Publications Office, please insert reference to
Regulation (EU) of the European Parliament and of the Council on plants obtained by
certain new genomic techniques and their food and feed13 and if that FRM belongs to
the tested category.
(30) The official label should contain information on basic material that contains or
consists of a genetically modified organism or that has been produced by certain new
genomic techniques.
-------------------------------
11 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the
deliberate release into the environment of genetically modified organisms and repealing Council
Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
12 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003
on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).
13 Regulation (EU) …/… of the European Parliament and of the Council …. (OJ …, p.).
Pag. 21
(31) Professional operators should be authorised by the competent authority to print the
official label under official supervision for certain species and categories of FRM. This
will give more flexbility to the professional operators in relation to the subsequent
marketing of that FRM. However, professional operators can only start printing the
label once competent authority has certified the FRM concerned. That authorisation is
necessary due to the official character of the official label and to guarantee the highest
possible quality standards for the users of FRM. Rules should be set out for the
withdrawal or modification of that authorisation.
(32) Member States should be allowed to impose additional or more stringent requirements
for the approval of basic material produced in their own territory, subject to
authorisation granted by the Commission. This would enable the implementation of
national or regional approaches concerning the production and marketing of FRM and
aimed at improvement of the quality of the FRM concerned, protection of the
environment, or contribution to the protection of biodiversity and the restoration of
forest ecosystems.
(33) In order to ensure transparency and more effective controls on the production and
marketing of FRM, professional operators should be registered in the registers
established by Member States pursuant to Regulation (EU) 2016/2031 of the European
Parliament and of the Council14
. Such registration reduces the administrative burden
for those professional operators. It is necessary for the efficacy of the official register
of professional and to avoid double registration. The professional operators under the
scope of this Regulation are to a big extent covered by the scope of the official register
of professional operators under Regulation (EU) 2016/2031.
(34) Prior to the purchase of FRM, professional operators should make available to the
potential buyers of their FRM all the necessary information concerning its suitability
for the respective climatic and ecological conditions, in order to allow them to select
the most appropriate FRM for their region.
(35) In the case of basic material intended for the production of FRM of the ‘source identified’ and ‘selected’ categories, the Member States should, for the relevant
species, demarcate the regions of provenance, in order to identify an area or groups of
areas with sufficiently uniform ecological conditions and containing basic material
with similar phenotypic or genetic characteristics. This is necessary because the FRM
produced from that basic material is to be marketed with reference to those regions of
provenance.
(36) To ensure an effective overview and transparency about the FRM that is produced and
marketed throughout the Union, each Member State should establish, publish and keep
updated, in electronic format, a national register of the basic material of the various
species and artificial hybrids approved on its territory, and a national list which should
be presented as a summary of the national register.
(37) For the same reason, the Commission should publish in electronic format a Union list
of approved basic material for the production of FRM, on the basis of the national lists
provided by each Member State. That Union list should contain information on basic
---------------------------
14 Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on
protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No
652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council
Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC
(OJ L 317, 23.11.2016, p. 4).
Pag. 22
material that contains or consists of a genetically modified organism or that has been
produced by certain new genomic techniques.
(38) Each Member State should draw up and keep up to date a contingency plan to ensure a
sufficient supply of FRM, to reforest areas affected by extreme weather events,
wildfires, disease and pest outbreaks, disasters or any other event. Rules should be set
out concerning the content of that plan, in order to ensure proactive and effective
action against such risks, if they emerge. Member States should be allowed to adapt
the content of that plan to the specific climatic and ecological conditions in their
territories. This requirement also reflects the general preparedness actions that
Member States should take on a voluntary basis under the Union Civil Protection
Mechanism15
.
(39) FRM should, during all stages of production, be kept separate by reference to
individual units of approval. Those units of approval should be produced and marketed
in lots, that must be sufficiently homogeneous and identified as distinct from other lots
of FRM. A distinction should be made between seed lots and plant lots, to identify the
type of FRM and ensure traceability to the approved basic material from which FRM
has been harvested. This guarantees the maintenance of the identity and quality of that
FRM.
(40) Seeds should be marketed only if they conform to certain quality standards. They
should be labelled and marketed only in sealed packages, in order to enable their
appropriate identification, quality and traceability, and to avoid fraud.
(41) In order to meet the aim of the EU Digital Strategy16 to make the transformation to
digital technologies work for people and businesses, the power to adopt acts in
accordance with Article 290 of the Treaty on the Functioning of the European Union
(‘TFEU’) should be delegated to the Commission in respect of rules on rules on digital
recording of all actions taken, for the purpose of issuing a master certificate and an
official label and the establishment of a centralised platform facilitating the processing
of, access to, and use of those records.
(42) During periods in which there are temporary difficulties in harvesting sufficient
supplies of FRM from certain species, basic material satisfying less stringent
requirements should, subject to certain conditions, be temporarily approved. Those
less stringent requirements should concern the approval of basic material intended for
the production of different categories of FRM. This is necessary to ensure a flexible
approach under adverse circumstances and to avoid disruptions of the internal market
of FRM’.
(43) FRM should only be imported from third countries, if it is established that it fulfils
requirements equivalent to those applicable to FRM produced and marketed in the
Union. This is necessary in order to ensure that such imported FRM affords the same
level of quality as the FRM produced in the Union.
(44) Where FRM is imported into the Union from a third country, the professional operator
concerned should inform the respective competent authority in advance of the import
----------------------------
15 Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a
Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
16 Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions, 2030 Digital
Compass: the European way for the Digital Decade (COM(2021)118 final).
Pag. 23
of FRM, through the information management system for official controls (IMSOC)
set up pursuant to Regulation (EU) 2017/625 of the European Parliament and of the
Council17
. Moreover, imported FRM should be accompanied by a master certificate or
an official certificate issued by the third country of origin, and records containing
details of that FRM provided by the professional operator in that third country. An
official label should be attached to that FRM, as this is necessary to ensure informed
choices for the users of that FRM and facilitate the competent authorities with the
conduct of the respective official controls.
(45) In order to monitor the impact of this Regulation and to allow the Commission to
assess the measures introduced, Member States should report every 5 years about the
annual quantities of certified FRM, the adopted national contingency plans, the
information available to users on where to best plant FRM through websites and/or
planters’ guides, the quantities of imported FRM and the penalties imposed.
(46) In order to adapt to the movement of vegetation zones and tree species’ ranges as a
result of climate change, and any other developments of technical or scientific
knowledge, including about climate change, the power to adopt acts in accordance
with Article 290 TFEU should be delegated to the Commission in respect of amending
the list of the tree species, and artificial hybrids thereof, to which this Regulation
applies.
(47) In order to adapt to the development of scientific and technical knowledge and of the
OECD Forest Seed and Plant Scheme and other applicable international standards, and
to take account of Regulation (EU) 2018/848 of the European Parliament and of the
Council18
, the power to adopt acts in accordance with Article 290 TFEU should be
delegated to the Commission in respect of amending (i) the requirements concerning
basic material intended for the production of FRM to be certified as ‘source identified’, ‘selected’, ‘qualified’, and ‘tested’ and (ii) the categories under which
FRM from the different types of basic material may be marketed.
(48) In order to allow a more flexible approach for the Member States, the power to adopt
acts in accordance with Article 290 TFEU should be delegated to the Commission in
respect of setting out the conditions for temporarily authorising the marketing of FRM
which does not meet all the requirements of the appropriate category.
(49) In order to adapt to the technical and scientific developments, the power to adopt acts
in accordance with Article 290 TFEU should be delegated to the Commission in
respect of setting out the requirements to be fulfilled by fruit and seed lots of the
species covered by this Regulation, to be fulfilled by parts of plants of the species and
artificial hybrids covered by this Regulation, for external quality standards for Populus
----------------------------
17 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official
controls and other official activities performed to ensure the application of food and feed law, rules on
animal health and welfare, plant health and plant protection products, amending Regulations (EC) No
999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No
652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council
Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC,
2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC)
No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC,
89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision
92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
18 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic
production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ
L 150, 14.6.2018, p. 1).
Pag. 24
spp. propagated by stem cuttings or sets, to be fulfilled by planting stock of the species
and artificial hybrids covered by this Regulation, and to be fulfilled by planting stock
to be marketed to final users in regions having a Mediterranean climate.
(50) In order to adapt with the EU Digital Strategy and the technical developments in the
digitisation of services, the power to adopt acts in accordance with Article 290 TFEU
should be delegated to the Commission in respect of establishing rules concerning
digital recording of all actions taken by the professional operator and the competent
authorities, in order to issue the master certificate, and concerning the establishment of
a centralised platform that connects all the Member States and the Commission.
(51) It is of particular importance that the Commission carry out appropriate consultations
during its preparatory work for those delegated acts, including at expert level, and that
those consultations be conducted in accordance with the principles laid down in the
Interinstitutional Agreement of 13 April 2016 on Better Law-Making19. In particular,
to ensure equal participation in the preparation of delegated acts, the European
Parliament and the Council receive all documents at the same time as Member States’
experts, and their experts systematically have access to meetings of Commission
expert groups dealing with the preparation of delegated acts.
(52) In order to ensure uniform conditions for the implementation of this Regulation,
implementing powers should be conferred on the Commission with respect to the
establishment of specific conditions as regards the requirements and content of the
notification of the basic material.
(53) In order to ensure uniform conditions for the implementation of this Regulation, and
facilitate the recognisibility and use of master certificates, implementing powers
should be conferred on the Commission with respect to adopting the content and the
model for the master certificate of identity for FRM derived from seed sources and
stands, FRM derived from seed orchards or parents of family(ies), and FRM derived
from clones and clonal mixtures.
(54) In order to ensure uniform conditions for the implementation of this Regulation, and
ensure a harmonised framework for the labelling and provision of information
concerning FRM, implementing powers should be conferred on the Commission with
respect to setting out the content of the official label, the additional information in the
case of seeds and small quantities of seeds, the colour of the label for specific
categories or other types of FRM, and additional information in the case of specific
genera or species.
(55) In order to ensure uniform conditions for the implementation of this Regulation, and
adapt to the developments concerning the digitisation of the FRM sector,
implementing powers should be conferred on the Commission with respect to setting
out the technical arrangements for the issuance of electronic master certificates.
(56) In order to ensure uniform conditions for the implementation of this Regulation, and to
address urgent supply problems of FRM,implementing powers should be conferred on
the Commission with respect to temporarily approving for marketing FRM of one or
more species which satisfies less stringent requirements than the ones set out in this
Regulation concerning the approval of basic material.
-------------------------
19 OJ L 123, 12.5.2016, p. 1.
Pag. 25
(57) In order to ensure uniform conditions for the implementation of this Regulation,
implementing powers should be conferred on the Commission with respect to deciding
on the organisation of temporary experiments to seek improved alternatives to the
requirements of this Regulation as regards the assessment and approval of basic
material and the production and marketing of FRM.
(58) To improve consistency of FRM rules with the Union plant health legislation, Articles
36, 37, 40, 41, 49, 53 and 54 of Regulation (EU) 2016/2031 should apply to the
production and marketing of FRM pursuant to this Regulation. In order to ensure
consistency with the rules of Regulation (EU) 2016/2031 on plant passports, it should
be allowed to combine the official label for FRM with the plant passport.
(59) Regulation (EU) 2017/625 should be amended in order to include in its scope rules on
official controls in regards to FRM. This is to ensure more consistent official controls
and enforcement of the rules across Member States concerning FRM, and consistency
with other Union acts concerning the official controls of plants, in particular,
Regulation (EU) 2016/2031 and Regulation (EU) …/… of the European Parliament
and of the Council.
(60) Regulations (EU) 2016/2031 and 2017/625 should therefore be amended accordingly.
(61) For reasons of legal clarity and transparency, Directive 1999/105/EC should be
repealed.
(62) Since the objective of this Regulation, namely to ensure a harmonised approach with
regard to the production and marketing of FRM, cannot be sufficiently achieved by the
Member States but can rather, by reason of its effects, complexity, and international
character, be better achieved at Union level, the Union may adopt measures, in
accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on
European Union. In accordance with the principle of proportionality, as set out in that
Article, this Regulation does not exceed what is necessary in order to achieve that
objective. In this view, and as necessary, it introduces derogations or specific
requirements for certain types of FRM and professional operators.
(63) In view of the time and resources required for the competent authorities and the
professional operators concerned to adapt to the new requirements set out in this
Regulation, this Regulation should apply from … [3 years from the date of entry into
force of this Regulation],
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
This Regulation sets out rules concerning the production and marketing of forest reproductive
material (‘FRM’) and in particular requirements for the approval of basic material intended
for the production of FRM, the origin and traceability of that basic material, FRM categories,
requirements for FRM identity and quality, certification, labelling, packaging, imports,
professional operators, the registration of basic material and the national contingency plans.
Pag. 26
Article 2
Scope
1. This Regulation applies to FRM of the tree species and artificial hybrids thereof,
listed in Annex I.
2. The objectives of this Regulation are the following:
(a) ensure the production and marketing of high-quality FRM in the Union and the
functioning of the internal market in FRM;
(b) help create resilient forests, conserve biodiversity and restore forest
ecosystems;
(c) support wood and biomaterials production, climate adaptation, climate
mitigation and the conservation and sustainable use of forest genetic resources.
3. The Commission shall be empowered to adopt delegated acts, in accordance with
Article 26, amending the list set out in Annex I as specified in paragraph 3, taking
into account:
(a) the movement of vegetation zones and tree species’ ranges as a result of
climate change;
(b) any developments of technical or scientific knowledge.
Those delegated acts shall add species and artificial hybrids to the list in Annex I, if
such species and artificial hybrids fulfil at least one of the following elements:
(a) represent a significant area and economic value of FRM production in the
Union;
(b) are marketed in at least two Member States;
(c) are considered important for their contribution to adaptation to climate change,
and
(d) are considered important for their contribution to the conservation of
biodiversity.
The delegated acts referred to in the first subparagraph shall remove species and
artificial hybrids from the list in Annex, I if they no longer fulfil any of the elements
set out in the first subparagraph.
4. This Regulation does not apply to the following:
(a) plant reproductive material referred to in Article 2 of Regulation (EU) …/…
[Office of Publications, please insert reference to Regulation on production
and marketing of plant reproductive material];
(b) propagating material of ornamental plants as defined in Article 2 of Directive
98/56/EC;
(c) FRM produced for export to third countries;
(d) FRM used for official testing, scientific purposes or selection work.
Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:
Pag. 27
(1) ‘forest reproductive material’ (‘FRM’) means cones, infructescenses, fruits and seeds
intended for the production of a planting stock, that belong to tree species and
artificial hybrids thereof listed in Annex I to this Regulation and used for
afforestation, reforestation and other tree planting for any of the following purposes:
(a) wood and biomaterials production;
(b) biodiversity conservation;
(c) restoration of forest ecosystems;
(d) climate adaptation;
(e) climate mitigation;
(f) conservation and sustainable use of forest genetic resources.
(2) ‘afforestation’ means establishment of forest through planting and/or deliberate
seeding on land that, until then, was under a different land use implies a
transformation of land use form non-forest to forest20;
(3) ‘reforestation’ means re-establishment of forest through planting and/or deliberate
seeding on land classified as forest21;
(4) ‘seed unit’ means cones, infructescenses, fruits and seeds intended for the production
of a planting stock;
(5) ‘planting stock’ means any plant or part of a plant used in plant propagation and
comprises plants raised from seed units, from parts of plants, or from plants from
natural regeneration;
(6) ‘parts of plants’ means stem cuttings, leaf cuttings and root cuttings, explants or
embryos used for micropropagation, buds, layers, roots, scions, sets and any other
parts of a plant used for the production of a planting stock;
(7) ‘production’ means all stages in the generation of the seed and plants, the conversion
from seed unit to seed, and the raising of plants from a planting stock, with a view
for the respective FRM to be marketed;
(8) ‘seed source’ means the trees within an area, from which seed is collected;
(9) ‘stand’ means a delineated population of trees possessing sufficient uniformity in
composition;
(10) ‘seed orchard’ means a plantation of selected trees, where each tree is identified by a
clone, family or provenance, which is isolated or managed to avoid or reduce
pollination from outside sources, and managed to produce frequent, abundant and
easily harvested crops of seed;
(11) ‘parents of family(ies)’ means trees used as parents to obtain progeny by controlled
or open pollination of one identified parent used as a female (‘mother tree’), with the
pollen of one ‘father tree’, full sibling) or a number of identified or unidentified
‘father trees’ (half-sibling);
----------------------
20 FAO (2020) Global Forest Resources Assessment Terms and definitions.
https://www.fao.org/3/I8661EN/i8661en.pdf.
21 FAO (2020) Global Forest Resources Assessment Terms and definitions.
https://www.fao.org/3/I8661EN/i8661en.pdf.
Pag. 28
(12) ‘clone’ means a group of individuals (ramets) derived originally from a single
individual (ortet) by vegetative propagation, for example by cuttings,
micropropagation, grafts, layers or divisions;
(13) ‘clonal mixture’ means a mixture of identified clones in defined proportions;
(14) ‘basic material’ means any of the following: seed source, stand, seed orchard, parents
of family(ies), clone or clonal mixtures;
(15) ‘unit of approval’ means the entire area of basic material for the production of FRM
that has been authorised by the competent authorities;
(16) ‘unit of notification’ means the entire area of basic material for the production of
FRM intended for the purpose of the conservation and sustainable use of forest
genetic resources that has been notified to the competent authorities;
(17) ‘seed lot’ means a set of seeds collected from approved basic material and processed
uniformly;
(18) ‘plant lot’ means a set of planting stock that has been grown from a single seed lot or
a vegetatively propagated planting stock which has been raised in a delineable area
and processed uniformly;
(19) ‘lot number’ means the identification number of the seed lot or plant lot, as
appropriate;
(20) ‘provenance’ means the place in which any stand of trees is growing;
(21) ‘sub-species’ means a group within a species that has become somewhat
phenotypically and genetically different from the rest of the group;
(22) ‘region of provenance’ means, in regard to species or sub-species, the area or group
of areas subject to sufficiently uniform ecological conditions, in which stands or seed
sources showing similar phenotypic or genetic characteristics are found, taking into
account altitudinal boundaries, where appropriate;
(23) ‘autochthonous stand’ means a stand of native tree species which has been
continuously regenerated either by natural regeneration or artificially from FRM
collected in the same stand or stands of native tree species within close proximity;
(24) ‘indigenous stand’ means an autochthonous stand or a stand raised artificially from
seed, where the origin of this stand and the stand itself are located in the same region
of provenance;
(25) ‘origin’ means the following:
(a) for an autochthonous seed source or stand, the place in which the trees are
growing;
(b) for a non-autochthonous seed source or stand, the place from which the seed or
plants were originally introduced;
(c) for a seed orchard, the places where its components were originally located,
such as their provenances or other relevant geographical information;
(d) for the parents of families, the places where their components were originally
located, such as their provenances or other relevant geographical information;
(e) for a clone, the origin is the place, where the ortet is or was initially located or
selected;
Pag. 29
(f) for a clonal mixture, the origins are the places, where the ortets are or were
initially located or selected;
(26) ‘location of the basic material’ means the geographical area or geographical
position(s) of the basic material as appropriate for each category of FRM;
(27) ‘place of production of clones or clonal mixtures or parents of families’ means the
place or exact geographical position, where the FRM was produced;
(28) ‘foundation stock’ means a plant, group of plants, FRM, DNA stock or genetic
information of the clone, or clones in case of clonal mixture, that serves as a
reference material for the control of the identity of the clone(s);
(29) ‘set’ means a stem cutting without roots;
(30) ‘marketing’ means the following actions conducted by a professional operator: sale,
holding or offering for the purpose of sale or any other way of transferring,
distribution within, or import into the Union, whether free of charge or not, of FRM;
(31) ‘professional operator’ means any natural or legal person involved professionally in
one or more of the following activities:
(a) production, including growing, multiplying and maintaining of the FRM;
(b) marketing of the FRM;
(c) storage, collection, dispatching and processing of the FRM;
(32) ‘competent authority’ means a central or regional authority of a Member State, or,
where applicable, the corresponding authority of a third country, responsible for the
organisation of official controls, registration of basic material, certification of FRM
and other official activities concerning the production and marketing of FRM, or any
other authority to which that responsibility has been conferred, in accordance with
Union law;
(33) ‘source-identified’ means a category of FRM derived from basic material consisting
of either a seed source or stand located within a single region of provenance and
which meets the requirements set out in Annex II;
(34) ‘selected’ means a category of FRM derived from basic material consisting of a stand
located within a single region of provenance, which has been phenotypically selected
at the population level and which meets the requirements set out in Annex III;
(35) ‘qualified’ means a category of FRM derived from basic material consisting of seed
orchards, parents of family(ies), clones or clonal mixtures, the components of which
have been phenotypically selected at the individual level, and which meets the
requirements set out in Annex IV;
(36) ‘tested’ means a category of FRM derived from basic material consisting of stands,
seed orchards, parents of family(ies), clones or clonal mixtures and which meets the
requirements set out in Annex V;
(37) ‘official certification’ means certification of source-identified, selected, qualified and
tested FRM, if all relevant inspections and, where appropriate, sampling and FRM
testing have been carried out by the competent authority and if it has been concluded
that the FRM meets the respective requirements of this Regulation;
(38) ‘category’ means FRM that qualifies as source-identified, selected, qualified or
tested material;
Pag. 30
(39) ‘genetically modified organism’ means a genetically modified organism as defined in
Article 2(2) of Directive 2001/18/EC, excluding organisms obtained through the
techniques of genetic modification listed in Annex I B to Directive 2001/18/EC;
(40) ‘NGT plant’ means plants obtained by certain new genomic techniques as defined in
Article 3, point 2 of Regulation (EU) [Office of Publications, please insert reference
to Regulation on plants obtained by certain new genomic techniques and their food
and feed] of the European Parliament and of the Council 22;
(41) ‘seed transfer zones’ means an area and/or altitudinal zones designated by the
competent authorities for the movement of FRM belonging to the source-identified
and selected categories, taking into account, as appropriate, the origin and
provenance of the FRM, provenance trials, environmental conditions and future
climatic change projections;
(42) ‘deployment area for seed orchards’ means the area designated by the competent
authorities, in which FRM belonging to the qualified and tested categories is adapted
to the climatic and ecological conditions of that area, taking into account, as
appropriate, the location of the seed orchards and its components, results of progeny
and provenance trials, environmental conditions and future climatic change
projections;
(43) ‘deployment area for clones and clonal mixtures’ means the area designated by the
competent authorities, in which FRM belonging to the qualified and tested categories
is adapted to the climatic and ecological conditions of that area, taking into account,
as appropriate, the origin or provenance of the clone(s), results of progeny and
provenance trials, the environmental conditions and future climatic change
projections;
(44) ‘FOREMATIS’ means the Forest Reproductive Material Information System of the
Commission;
(45) ‘natural regeneration’ means the renewal of a forest by trees that develop from seeds
which have fallen and germinated in situ
(46) ‘quality pests’ means pests fulfilling all of the following:
(a) they are not Union quarantine pests, protected zone quarantine pests, or
regulated non-quarantine pests (‘RNQPs’) within the meaning of Regulation
(EU) 2016/2031, nor pests subject to the measures adopted pursuant to Article
30(1) of that Regulation;
(b) they occur during FRM production or storage; and
(c) their presence has an unacceptable adverse impact on the quality of the FRM,
and an unacceptable economic impact as regards the use of that FRM in the
Union;
(47) ‘practically free from pests’ means completely free from pests, or a situation where
the presence of quality pests on the respective FRM is so low that those pests do not
affect adversely the quality of that FRM.
----------------------
22 Regulation (EU) .../... of the European Parliament and of the Council on plants obtained by certain new
genomic techniques and their food and feed, and amending Directives 68/193/EEC, 1999/105/EC,
2002/53/EC, 2002/55/EC, and Regulation (EU) 2017/625 (OJ ...).
Pag. 31
CHAPTER II
BASIC MATERIAL AND FRM DERIVING FROM IT
Article 4
Approval of basic material for the production of FRM
1. Only basic material approved by the competent authorities may be used for the
production of FRM.
2. Basic material intended for the production of FRM to be certified as ‘source identified’ shall be approved, if it fulfils the requirements set out in Annex II.
Basic material intended for the production of FRM to be certified as ‘selected’ shall
be approved, if it fulfils the requirements set out in Annex III.
Basic material intended for the production of FRM to be certified as ‘qualified’ shall
be approved, if it fulfils the requirements set out in Annex IV.
Basic material intended for the production of FRM to be certified as ‘tested’ shall be
approved, if it fulfils the requirements set out in Annex V.
The assessment of the requirements laid down in Annexes II to V for the approval of
basic material, may include besides visual inspection, documentary checks, tests and
analyses or other complementary methods, also the use of bio-molecular techniques,
if they are considered more appropriate for the purpose of that approval.
The basic material for all categories shall be assessed for its sustainability
characteristics as set out in Annexes II to V, to take into account the climatic and
ecological conditions.
The approval of the basic material shall be carried out with a reference to the unit of
approval.
The Commission is empowered to adopt delegated acts in accordance with Article 26
amending Annexes II, III, IV and V, as regards requirements for the approval of
basic material intended for the production of:
(a) FRM of ‘source-identified’ category, and in particular the requirements
concerning types of basic material, effective size of the population, origin and
region of provenance, sustainability characteristics;
(b) FRM of the ‘selected’ category, and in particular the requirements concerning
origin, isolation, effective size of the population, age and development,
uniformity, sustainability characteristics, volume production, wood quality, and
form or growth habit;
(c) FRM of the ‘qualified’ category, and in particular the requirements concerning
orchards, parents of family(ies), clones, and clonal mixtures;
(d) FRM of the ‘tested’ category, and in particular the requirements concerning
characteristics to be examined, documentation, setting up the tests, analysis and
validity of the tests, the genetic evaluation of the components of basic material,
the comparative testing of FRM, provisional approval and early tests;
(e) FRM in accordance with the requirements of Regulation (EU) 2018/848 of the
European Parliament and of the Council.
Pag. 32
Those amendments shall adapt the rules for the approval of basic material to the
development of scientific and technical knowledge, and the development of the
OECD Forest Seed and Plant Scheme and other applicable international standards.
3. Only approved basic material shall be included under the form of a unit of approval
in the national register pursuant to Article 12. Each unit of approval shall be
identified by a unique register reference in a national register.
4. The approval of basic material shall be withdrawn, if the requirements set out in this
Regulation are no longer met.
5. After approval, the basic material intended for the production of FRM under the
selected, qualified and tested categories shall be re-inspected by the competent
authorities at regular intervals.
6. The Commission is empowered to adopt delegated acts in accordance with Article 26
amending Annexes II, III, IV and V, in order to adapt them to the development of
scientific and technical knowledge, in particular regarding the use of bio-molecular
techniques and to the relevant international standards.
Article 5
Requirements for the marketing of FRM derived from approved basic material
1. FRM derived from approved basic material shall be marketed in accordance with the
following rules:
(a) FRM of the species listed in Annex I may only be marketed, if it is of the
categories ‘source-identified’, ‘selected’, ‘qualified’ or ‘tested’, and it has been
derived from basic material that has been approved pursuant to Article 4 and if
that basic material meets the requirements of Annexes II, III, IV and V,
respectively;
(b) FRM of the artificial hybrids listed in Annex I may only be marketed, if it is of
the ‘selected’, ‘qualified’ or ‘tested’ categories, and it has been derived from
basic material that has been approved pursuant to Article 4 and if that basic
material meets the requirements of Annexes III, IV and V, respectively;
(c) FRM of the tree species and artificial hybrids listed in Annex I, which are
vegetatively reproduced, may only be marketed if:
(i) it is of the ‘selected’, ‘qualified’ or ‘tested’ categories, and
(ii) it has been derived from basic material which has been approved
pursuant to Article 4 and which meets the requirements of Annexes III,
IV and V, respectively;
(iii) FRM of the ‘selected’ category, may only be marketed if it has been
mass propagated from seeds;
(d) FRM of the tree species and artificial hybrids listed in Annex I, which contains
or consists in genetically modified organisms, may only be marketed if:
(i) it is of the ‘tested’ category, and
(ii) it has been derived from basic material which has been approved
pursuant to Article 4 and which meets the requirements of Annex V; and
Pag. 33
(iii) it is authorised for cultivation in the Union pursuant to Article 19 of
Directive 2001/18/EC or Articles 7 and 19 of Regulation (EC)
1829/2003, or, where applicable, in the respective Member State in
accordance with Article 26b of Directive 2001/18/EC;
(e) FRM of the tree species and artificial hybrids listed in Annex I, which contain
or consist of a category 1 NGT plant as defined in Article 3(7) of Regulation
(EU) …/… (Office of Publications, please insert reference to NGT Regulation
...), may only be marketed if:
(i) it is of the ‘tested’ category, and
(ii) it has been derived from basic material which has been approved
pursuant to Article 4 and which meets the requirements of Annex V; and
(iii) the plant has obtained a declaration of category 1 NGT plant status
pursuant to Article 6 or 7 of Regulation (EU) …/… (Office of
Publications, please insert reference to NGT Regulation ...) or is progeny
of such plant(s);
(f) FRM of the tree species and artificial hybrids listed in Annex I, may only be
marketed if it is accompanied by a reference to its master certificate number(s);
(g) it complies with Articles 36, 37, 40, 41, 42, 49, 53 and 54 of Regulation (EU)
2016/2031 concerning Union quarantine pests, protected zone quarantine pests,
RNQPs, and pests subject to the measures under Article 30 of that Regulation;
(h) In the case of seeds, FRM of the tree species and artificial hybrids listed in
Annex I, may only be marketed, if in addition to compliance with points (a) to
(g), information is available as regards:
(i) purity;
(ii) germination percentage of the pure seed;
(iii) weight of 1000 pure seeds;
(iv) the number of germinable seeds per kilogram of product marketed as
seed, or, where the number of germinable seeds is impossible or
impractical to assess, the number of viable seeds per kilogram.
2. The categories under which FRM from the different types of basic material may be
marketed are as set out in the table in Annex VI.
3. The Commission is empowered to adopt delegated acts in accordance with Article
26(2), amending the table of Annex VI concerning categories under which FRM
from the different types of basic material may be marketed.
That amendment shall adapt those categories to the development of scientific and
technical knowledge and of the relevant international standards.
Article 6
Requirements for FRM derived from basic material intended for the purpose of
conserving forest genetic resources
In order for FRM derived from basic material subject to the derogation of Article 18 to be
marketed, all the following conditions shall be fulfilled:
Pag. 34
(a) FRM of the species listed in Annex I may only be marketed, if it is of the ‘source identified’ category;
(b) FRM shall be of origin which is naturally adapted to the local and regional conditions;
and
(c) FRM shall be collected from all individuals of the notified basic material.
Article 7
Temporary authorisation of marketing of FRM derived from basic material not meeting
the category requirements
1. Competent authorities may temporarily authorise the marketing of FRM derived
from approved basic material which does not meet all the requirements of the
appropriate category referred to in Article 5(1), following the adoption of the
delegated act referred to in paragraph 2.
The competent authorities of the respective Member State shall notify the
Commission and the other Member States of those temporary authorisations and of
the respective reasons justifying their approval.
2. The Commission is empowered to adopt delegated acts, in accordance with Article
26, supplementing this Article, by setting out the conditions for the granting of the
temporary authorisation to the Member State concerned.
Those conditions shall include:
(a) the justification for granting that authorisation to ensure achievement of the
objectives of this Regulation;
(b) the maximum duration of the authorisation;
(c) obligations as regards official controls on the professional operators applying
that authorisation;
(d) the content and form of the notification referred to in paragraph 1.
Article 8
Special requirements for certain species, categories and types of FRM
The Commission is empowered to adopt delegated acts, in accordance with Article 26,
supplementing, as necessary, this Regulation as regards the requirements as appropriate for
each type, species or category of FRM:
(a) concerning fruit and seed lots of the species listed in Annex I as regards species
purity;
(b) concerning parts of plants of the species and artificial hybrids listed in Annex I as
regards quality in relation to general characteristics, health and size;
(c) for external quality standards for Populus spp. propagated by stem cuttings or sets as
regards defects and minimum dimensions for stem cuttings and sets;
(d) concerning planting stock of the species and artificial hybrids listed in Annex I as
regards quality in relation to general characteristics, health, vitality and physiological
quality;
Pag. 35
(e) concerning planting stock to be marketed to users in regions having a Mediterranean
climate as regards defects, size and age of the plants and, where appropriate, size of
the container.
That delegated act shall be based on the experience gained by the application of the
requirements as appropriate for each type, species or category of FRM as regards the
provisions for inspections, sampling and testing, and isolation distances. It shall adapt those
requirements based on the development of the respective international standards, the technical
and scientific developments, or the climatic and ecological developments.
Article 9
Contingency plan and national register
1. Each Member State shall draw up one or more contingency plan to ensure a
sufficient supply of FRM to reforest areas affected by extreme weather events,
wildfires, disease and pest outbreaks, disasters or any other event, as relevant and
identified in the national risk assessments develop in accordance with Article 6(1) of
Decision No 1313/2013/EU23
.
That contingency plan shall be prepared for those tree species and artificial hybrids
thereof listed in Annex I, that are deemed suitable for the current and projected future
climatic and ecological conditions of the Member State concerned.
The contingency plan shall take into account the projected future distribution of the
relevant tree species and artificial hybrids thereof, on the basis of national and/or
regional climate model simulations for the Member State concerned.
2. Member States shall, at an appropriate stage, consult all relevant stakeholders in the
process of drawing up and keeping up to date such contingency plans.
3. Each contingency plan shall include the following:
(a) the roles and responsibilities of the bodies involved in the execution of the
contingency plan in case of any event causing a major shortage of FRM, as
well as the chain of command and procedures for the coordination of actions to
be taken by competent authorities, other public authorities, delegated bodies or
natural persons involved, laboratories and professional operators, including the
coordination with neighbouring Member States and neighbouring third
countries, where appropriate;
(b) access of competent authorities to supplies of FRM that have been maintained
for the purpose of contingency planning, premises of professional operators, in
particular forest nurseries and laboratories producing FRM, other relevant
operators and natural persons;
(c) access of competent authorities, where necessary, to equipment, personnel,
external expertise and resources necessary for the rapid and effective activation
of the contingency plan;
(d) measures concerning the submission of information to the Commission, the
other Member States, the professional operators concerned and the public, as
regards the major FRM shortage, and the measures taken against it in the event
of an officially confirmed or suspected major FRM shortage;
---------------------------------------
23 OJ L 347, 20.12.2013, p. 924.
Pag. 36
(e) arrangements for recording findings of the presence of any major FRM
shortage;
(f) the available assessments of the Member State as regards the risk of a major
FRM shortage for its territory and its potential impact on human, animal and
plant health, and the environment;
(g) principles for the geographical demarcation of the area(s) where a major FRM
shortage has occurred;
(h) principles concerning the training of personnel of the competent authorities
and, where appropriate, the bodies, public authorities, laboratories, professional
operators and other persons referred to in point (a).
Member States shall regularly review and, where appropriate, update their
contingency plans to take account of the technical and scientific developments in
relation to climate model simulations addressing the projected future distribution of
the relevant tree species and artificial hybrids thereof.
4. Member States shall establish a national register that:
(a) contains the tree species and artificial hybrids listed in Annex I, which are
relevant for the current climatic and ecological conditions of the Member State
concerned;
(b) takes account of the projected future distribution of those tree species and
artificial hybrids thereof.
Within 4 years from the date of establishment of their national registers, Member
States shall establish contingency plans for the species and artificial hybrids included
in their registers.
5. Member States shall collaborate with each other and with all relevant stakeholders
for the establishment of their contingency plans, on the basis of an exchange of best
practices and experience gained with the establishment of those plans.
6. Member States shall make their contingency plans available to the Commission, the
other Member States and all relevant professional operators through publication in
FOREMATIS.
CHAPTER III
REGISTRATION OF PROFESSIONAL OPERATORS AND
BASIC MATERIAL, AND DEMARCATION OF REGIONS OF
PROVENANCE
Article 10
Obligations for professional operators
1. Professional operators shall be registered in a register provided for in Article 65 of
Regulation (EU) 2016/2031, in accordance with Article 66 of that Regulation.
They shall be established in the Union.
2. Professional operators shall make available to the users of their FRM all necessary
information concerning its suitability for current and projected future climatic and
ecological conditions. That information shall, prior to the transfer of the FRM
Pag. 37
concerned, be provided to the potential purchaser through websites, planters’ guides
and other appropriate means.
Article 11
Demarcation of regions of provenance for certain categories
Member States shall, for the relevant species of basic material intended for the production of
FRM of the ‘source-identified’ and ‘selected’ categories, demarcate the regions of
provenance.
The competent authorities shall draw up and publish on their website maps showing the
demarcations of the regions of provenance. They shall make those maps available to the
Commission and other Member States through FOREMATIS.
Article 12
National register and national lists of basic material
1. Each Member State shall establish, publish and keep updated, in electronic format, a
national register of the basic material of the various species approved on its territory
pursuant to Articles 4 and 19 and notified pursuant to Article 18.
That register shall contain full details of each unit of approved basic material,
together with its unique register reference.
By way of derogation from Article 4, the competent authorities shall immediately
register in their national registers the basic material included, before … [OJ, please,
insert the date of the of this Regulation], in their respective national registers referred
to in Article 10(1) of Directive 1999/105/EC, without applying the registration
procedure set out in that Article.
2. Each Member State shall establish, publish and keep updated a national list of basic
material, which shall be presented as a summary of the national register. It shall
make that list available in electronic format to the Commission and the other
Member States through FOREMATIS.
3. Member States shall present the national list in a common form for each unit of
approval of basic material. For the categories ‘source-identified’ and ‘selected’, it
may contain only a summary description of the basic material, on the basis of regions
of provenance.
The national list shall provide in particular the following details:
(a) botanical name;
(b) category;
(c) basic material;
(d) register reference or, where appropriate, summary thereof, or identity code for
region of provenance;
(e) location of basic material: a short name, if appropriate, and one of the
following sets of particulars:
(i) for the ‘source-identified’ category, region of provenance and the
latitudinal, longitudinal and altitudinal range;
Pag. 38
(ii) for the ‘selected’ category, region of provenance and the geographical
position defined by latitude, longitude and altitude or the latitudinal,
longitudinal and altitudinal range;
(iii) for the ‘qualified’ category, the exact geographical position(s) defined by
latitude, longitude and altitude, where the basic material is maintained;
(iv) for the ‘tested’ category, the exact geographical position(s) defined by
latitude, and longitude and altitude, where the basic material is
maintained;
(f) area: the size of a seed source(s), stand(s) or seed orchard(s);
(g) origin:
(i) indication whether the basic material is autochthonous/indigenous, non autochthonous/non-indigenous or if the origin is unknown;
(ii) non-autochthonous/ non-indigenous basic material, an indication of the
origin, if it is known;
(h) purpose of use of FRM;
(i) in the case of FRM of the ‘tested’ category, an indication whether it is:
(i) genetically modified; or
(ii) an NGT plant;
(j) in the case of qualified and tested categories, information about the place of
production of clone(s) or clonal mixture(s), where appropriate.
Article 13
Union List of Approved Basic Material
1. On the basis of the national lists provided by each Member State in accordance with
Article 12, the Commission shall publish a list entitled ‘Union List of Approved
Basic Material for the Production of Forest Reproductive Material’.
That list shall be made available in electronic format through FOREMATIS.
2. That list shall reflect the details given in the national lists referred to in Article 12(1)
and show the area of utilisation.
CHAPTER IV
MASTER CERTIFICATE, LABELLING AND PACKAGING
Article 14
Master certificate of identity
1. The competent authorities shall issue, upon application of a professional operator,
after harvesting the FRM from approved basic material, a master certificate of
identity (‘master certificate’), showing the unique register reference of basic material,
for all FRM that has been harvested.
The master certificate shall attest compliance with the requirements of Article 4(2).
The Commission shall, by means of an implementing act, adopt the content and the
model for the master certificate of identity for FRM:
Pag. 39
(a) Model master certificate for FRM that is derived from seed sources and stands;
(b) Model master certificate for FRM that is derived from seed orchards or parents
of family(ies); and
(c) Model master certificate for FRM that is derived from clones and clonal
mixtures.
That implementing act shall be adopted in accordance with the examination
procedure referred to in Article 27(2).
2. Where in accordance with Article 15(2) a Member State adopts measures as regards
subsequent vegetative propagation, a new master certificate shall be issued.
3. Where mixing takes place in accordance with Article 15(3), Member States shall
ensure that the register references of the components of the mixtures are identifiable,
and a new master certificate or other document identifying the mixture shall be
issued.
4. Where a lot referred to in Article 15(1) is subdivided into smaller lots that are not
processed uniformly and subjected to subsequent vegetative propagation, a new
master certificate shall be issued and a reference shall be made to the previous master
certificate number.
5. A master certificate may also be issued in an electronic form (‘electronic master
certificate’).
The Commission may, by means of implementing acts, set out technical
arrangements for the issuance of electronic master certificates, for ensuring their
compliance with this Article and an appropriate, credible and effective mode for the
issuance of electronic master certificates. Those implementing acts shall be adopted
in accordance with the examination procedure referred to in Article 27(2).
6. The Commission is empowered to adopt delegated acts, in accordance with Article
26, supplementing this Article, by setting out rules on:
(a) digital recording of all actions taken by the professional operator and the
competent authorities, in order to issue the master certificate; and
(b) establishment of a centralised platform that connects all the Member States and
the Commission, to facilitate the processing of, access to and use of those
records.
Article 15
Lots
1. FRM shall, during all stages of production, be kept separated by reference to
individual units of approval of basic material to ensure traceability of the FRM to the
approved basic material from which it has been harvested. FRM shall be harvested
from those individual units of approval and marketed in lots that shall be sufficiently
homogeneous and identified as distinct from other lots of FRM.
Each lot of FRM shall be identified by the following:
(a) lot number;
(b) master certificate code and number;
(c) botanical name;
Pag. 40
(d) category of FRM;
(e) basic material;
(f) register reference or identity code for region of provenance;
(g) region of provenance for FRM of the ‘source-identified’ and ‘selected’
categories or other FRM if appropriate;
(h) if appropriate, whether the origin of the basic material is autochthonous or
indigenous, non-autochthonous or non-indigenous, or unknown;
(i) in the case of seed units, the year of ripening;
(j) age and type of planting stock of seedlings or cuttings, whether undercuts,
transplants or containerised;
(k) for the ‘tested’ category whether it is:
(i) genetically modified;
(ii) an NGT plant.
2. Without prejudice to paragraph 1 of this Article and to Article 5(1), point (c),
Member States shall keep separately FRM, which is subject to subsequent vegetative
propagation and shall identify it as such. Such FRM shall have been harvested from a
single unit of approval in the ‘selected’, ‘qualified’ and ‘tested’ categories. In such
cases, the produced FRM shall assume the same category as the original FRM.
3. Without prejudice to paragraph 1, the mixing of FRM shall be subject to the
following conditions, as appropriate:
(a) within the ‘source-identified’ or ‘selected’ categories, mixing shall apply to
FRM derived from two or more units of approval within a single region of
provenance;
(b) in the case of mixing of FRM within a single region of provenance, from seed
sources and stands in the ‘source-identified category, the new combined lot
shall be certified as ‘FRM derived from a seed source’;
(c) in the case of mixing of FRM derived from non-autochthonous or non indigenous basic material with that from basic material of unknown origin, the
new combined lot shall be certified as being ‘of unknown origin’;
(d) in the case of mixing of FRM derived from a single unit of approval from
different years of ripening, the actual years of ripening and proportion of FRM
from each year shall be recorded.
In the case of mixing in accordance with the first subparagraph, points (a), (b) or (c),
the identity code for the region of provenance may be substituted for the register
reference as in paragraph 1, point (f).
Article 16
Official label
1. An official label shall be issued by the competent authority for every lot of FRM
attesting compliance of that FRM with the requirements referred to in Article 5.
2. Competent authorities shall authorise the professional operator to print the official
label after the competent authority has attested compliance of that FRM with the
Pag. 41
requirements referred to in Article 5. The professional operator is authorised to print
that label, if, on the basis of an audit, the competent authority has concluded that the
operator possesses the infrastructure and resources to print the official label.
3. The competent authority shall carry out regular controls to check whether the
professional operator complies with the requirements referred to in paragraph 2.
Where, after having granted the authorisation referred to in paragraph 2, the
competent authority finds that a professional operator does not fulfil the requirements
referred to in that paragraph, it shall without delay withdraw, or modify as
appropriate, the authorisation.
4. In addition to the information required under Article 15(1), the official label shall
contain all the following information:
(a) master certificate number(s) issued in accordance with Article 14 or a reference
to the other document identifying the mixture available in accordance with
Article 14(3);
(b) name of the professional operator;
(c) quantity supplied;
(d) in the case of FRM of the ‘tested’ category, whose basic material is approved
under Article 4, the words ‘provisionally approved’;
(e) whether the FRM has been vegetatively propagated.
5. The Commission shall, by means of implementing acts, set out the following
elements concerning the official label:
(a) content of the official label;
(b) additional information in the case of seeds and small quantities of seeds;
(c) colour of the label for specific categories or other types of FRM;
(d) additional information in the case of specific genera or species.
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 27(2).
6. An official label may also be issued in an electronic form (‘electronic official label’).
The Commission may, by means of implementing acts, set out technical
arrangements for the issuance of electronic official labels, to ensure their compliance
with this Article and an appropriate, credible and effective mode for the issuance of
those official labels. Those implementing acts shall be adopted in accordance with
the examination procedure referred to in Article 27(2).
7. The Commission is empowered to adopt delegated acts, in accordance with Article
26, supplementing this Article, by setting out rules on:
(a) digital recording of all actions taken by the professional operators and the
competent authorities in order to issue the official labels;
(b) the establishment of a centralised platform that connects the Member States
and the Commission to facilitate the processing of, access to and use of those
records.
Pag. 42
Article 17
Packages of seed units
Seed units may only be marketed in sealed packages with that become unserviceable once the
package is opened.
CHAPTER V
DEROGATIONS FROM ARTICLE 4
Article 18
Derogation from the obligation to be approved for basic material intended for the
purpose of conserving forest genetic resources
1. By way of derogation from Article 4(1) and (2), the registration of basic material
intended for the purpose of conserving forest genetic resources in the national
register shall not be subject to approval by the competent authorities.
2. Any professional operator registering basic material for the purpose of conserving
forest genetic resources used in forestry, shall notify that basic material to the
competent authority of the Member State concerned.
3. Basic material referred to in paragraph 1 shall be notified to the competent
authorities in accordance with the format of FOREMATIS.
The notification of the basic material shall be carried out with reference to the unit of
notification.
Each unit of notification shall be identified by a unique register reference in a
national register.
That notification shall contain the following information:
(a) botanical name;
(b) category;
(c) basic material;
(d) register reference or, where appropriate, summary thereof, or identity code for
region of provenance;
(e) location: a short name, if appropriate, and the region of provenance and the
latitudinal, longitudinal and altitudinal range;
(f) area: the size of a seed source(s) or stand(s);
(g) origin: indication whether the basic material is autochthonous/indigenous, non autochthonous/non-indigenous or whether the origin is unknown. For non autochthonous/ non-indigenous basic material, indication of the origin if
known;
(h) purpose: conservation and sustainable use of genetic resources.
4. The Commission may, by means of implementing acts, establish the specific
conditions as regards the requirements and content of that notification. Those
implementing acts shall take account of the development of applicable international
standards and shall be adopted in accordance with the examination procedure
referred to in Article 27(2).
Pag. 43
Article 19
Approval by professional operators of basic material intended for the production of FRM of the source–identified category
By way of derogation from Article 4(1) and (2), Member States may authorise professional
operators to approve, for certain species, basic material intended for the production of FRM of
the source-identified category, if the following conditions are fulfilled:
(a) the region of provenance, where the basic material is located, is subject to extreme
weather conditions; and
(b) those weather conditions have an impact on the reproductive cycle of the basic
material and decrease the frequency of harvesting FRM from that basic material.
That authorisation shall be subject to approval by the Commission.
Article 20
Provisional approval of basic material intended for the production of FRM of the tested
category
By way of derogation from Article 4(2), Member States may allow the approval, for a
maximum period of 10 years, in all or part of their territory, of basic material intended for the
production of FRM of the ‘tested’ category where, from the provisional results of the genetic
evaluation or comparative tests referred to in Annex V, it can be assumed that once the tests
are completed, the basic material will satisfy the requirements for approval under this
Regulation.
Article 21
Temporary difficulties in supply
1. In order to overcome any temporary difficulties in the general supply of FRM that
occur in one or more Member States, the Commission may, at the request of at least
one Member States affected, temporarily authorise the Member States to approve for
marketing, by means of an implementing act, FRM of one or more species that has
been derived from basic material, which satisfies less stringent requirements than the
ones set out in Article 4(1) and (2).
2. Where the Commission acts in accordance with paragraph 1, the official label issued
pursuant to Article 16(1) shall state that the FRM concerned has been derived from
basic material which satisfies less stringent requirements than the ones set out in
Article 4(1) and (2).
3. The implementing act referred to in paragraph 1 shall be adopted in accordance with
the examination procedure referred to in Article 27(2).
Article 22
Temporary experiments to seek improved alternatives to provisions of this Regulation
1. By way of derogation from Articles, 1, 4 and 5, the Commission may decide, by
means of implementing acts, on the organisation of temporary experiments to seek
improved alternatives to provisions of this Regulation concerning the species or
artificial hybrids it applies to, the requirements for the approval of basic material and
the production and marketing of FRM.
Pag. 44
Those experiments may take the form of technical or scientific trials examining the
feasibility and appropriateness of new requirements compared to the ones set out in
Articles 1, 4 and 5 of this Regulation.
2. The implementing acts referred to in paragraph 1 shall be adopted in accordance with
the examination procedure referred to in Article 27(2) and shall specify one or more
of the following elements:
(a) the species or artificial hybrids concerned;
(b) the conditions of the experiments per species or artificial hybrid;
(c) the duration of the experiment;
(d) the monitoring and reporting obligations of the participating Member States.
Those acts shall take into account the evolution of:
(a) the methods for the determination of the origin of the basic material including
the use of biomolecular techniques;
(b) the methods for the conservation and sustainable use of forest genetic resources
taking into account applicable international standards;
(c) the methods for reproduction, production including the use of innovative
production processes;
(d) the methods for the design of crossing schemes of components of basic
material;
(e) the methods for the assessment of characteristics of basic material and FRM;
(f) the methods for the control of the FRM concerned.
Those acts shall adapt to the evolution of techniques for production of the FRM
concerned, and be based on any comparative trials and tests carried out by the
Member States.
3. The Commission shall review the results of those experiments and summarise them
in a report, indicating, if necessary, the need to amend Articles 1, 4 or 5.
Article 23
Authorisation to adopt more stringent requirements
1. By way of derogation from Article 4, the Commission, by means of implementing
acts, may authorise Member States to adopt, as regards the requirements for the
approval of basic material and the production of FRM more stringent production
requirements, than those referred to in that Article, in all or part of the territory of the
Member State concerned. Those implementing acts shall be adopted in accordance
with the examination procedure referred to in Article 27(2).
2. For the purpose of the authorisation referred to in paragraph 1, Member States shall
submit to the Commission a request setting out:
(a) the draft provisions containing the proposed requirements;
(b) a justification on the necessity and proportionality of such requirements.
3. The authorisation referred to in paragraph 1 shall be granted only if all the following
conditions are fulfilled:
Pag. 45
(a) the measures requested ensure at least one of the following:
(i) the improvement of the quality of the FRM concerned;
(ii) the protection of the environment: adaptation to climate change or the
contribution to the protection of biodiversity, restoration of forest
ecosystems;
(b) the measures requested are necessary and proportionate to their objective
pursuant to point (a); and
(c) the measures are justified on the basis of the specific climatic and ecological
conditions in the Member State concerned.
4. Where Member States have adopted additional or more stringent requirements
pursuant to Article 7 of Directive 1999/105/EC, the Member States concerned shall,
by … [one year after the date of application of this Regulation], review those
measures and repeal or amend those measures to comply with this Regulation.
They shall inform the Commission and the other Member States of those actions.
CHAPTER VI
IMPORTS OF FRM
Article 24
Imports on the basis of Union equivalence
1. FRM may be imported from third countries to the Union only if it is established,
pursuant to paragraph 2, that it fulfils requirements equivalent to those applicable to
FRM produced and marketed in the Union.
2. The Commission may decide, by means of implementing acts, if FRM of specific
genera, species οr categories produced in a third country, fulfils requirements
equivalent to those applicable to FRM produced and marketed in the Union, on the
basis of all of the following:
(a) a thorough examination of the information and data provided by the third
country concerned; and
(b) the satisfactory result of an audit carried out by the Commission in the third
country concerned, where that audit has been considered necessary by the
Commission;
(c) that third country participates in the OECD Scheme for the Certification of
Forest Reproductive Material Moving in International Trade.
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 27(2).
3. When adopting the decisions referred to in paragraph 1, the Commission shall
consider whether the systems, for approval and registration of basic material and
subsequent production of FRM from that basic material, applied in the third country
concerned provide the same guarantees as those provided for in Articles 4, 5 and,
where applicable, Article 11, for the ‘source identified’, ‘selected’, ‘qualified’ and
‘tested’ categories.
Pag. 46
Article 25
Notification and certificates of imported FRM
1. The professional operators importing FRM into the Union shall inform the respective
competent authority in advance of the import through the information management
system for official controls (IMSOC) referred to in Article 131 of Regulation (EU)
2017/625.
2. Imported FRM shall be accompanied by all of the following:
(a) a master certificate or another official certificate issued by the third country of
origin;
(b) an official label; and
(c) records containing details of that FRM provided by the professional operator in
that third country.
3. Following the import referred to in paragraph 1, the competent authority of the
Member State concerned shall replace:
(a) the master certificate or official certificate referred to in paragraph 2, point (a)
with a new master certificate issued in the Member State concerned; and
(b) the official label referred to in paragraph 2, point (b), with a new official label
issued in the Member State concerned.
CHAPTER VII
PROCEDURAL PROVISIONS
Article 26
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the
conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 2(2), Article 4(2) and(6),
Article 5(3), Article 7(2), Article 8(1), Article 14(6) and Article 16(7) shall be
conferred on the Commission for a period of 5 years from … [date of entry into force
of this Regulation]. The Commission shall draw up a report in respect of the
delegation of power no later than 9 months before the end of the five-year period.
The delegation of power shall be tacitly extended for periods of an identical duration
unless the European Parliament or the Council opposes such extension not later than
3 months before the end of each period.
3. The delegation of power referred to in Article 2(2), Article 4(2) and (6), Article 5(3),
Article 7(2), Article 8(1), Article 14(6) and Article 16(7) may be revoked at any time
by the European Parliament or by the Council. A decision to revoke shall put an end
to the delegation of the power specified in that decision. It shall take effect the day
following the publication of the decision in the Official Journal of the European
Union or at a later date specified therein. It shall not affect the validity of any
delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by
each Member State in accordance with the principles laid down in the
Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
Pag. 47
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to
the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 2(2), Article 4(2) and (6), Article 5(3),
Article 7(2), Article 8(1), Article 14(6) and Article 16(7) shall enter into force only if
no objection has been expressed either by the European Parliament or by the Council
within a period of 2 months of notification of that act to the European Parliament and
the Council or if, before the expiry of that period, the European Parliament and the
Council have both informed the Commission that they will not object. That period
shall be extended by 2 months at the initiative of the European Parliament or of the
Council.
Article 27
Committee procedure
1. The Commission shall be assisted by the Standing Committee on Plants, Animals,
Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002 of the
European Parliament and of the Council24. That committee shall be a committee
within the meaning of Regulation (EU) No 182/201125
.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No
182/2011 shall apply.
Where the opinion of the committee is to be obtained by written procedure, that
procedure shall be terminated without result when, within the time-limit for delivery
of the opinion, the chair of the committee so decides or a simple majority of
committee members so requests.
3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No
182/2011, in conjunction with Article 5 thereof, shall apply.
CHAPTER VIII
Reporting, penalties and amendments of Regulations (EU)
2016/2031 and 2017/625
Article 28
Reporting
By … [Office of Publications, please insert date of 5 years after the date of application of this
Regulation], and every 5 years thereafter, Member States shall transmit to the Commission a
report on the following:
(a) quantities of certified FRM per year;
(b) number of adopted national contingency plans to prepare for FRM supply difficulties
and the time needed to activate those contingency plans;
24 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying
down the general principles and requirements of food law, establishing the European Food Safety
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
25 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011
laying down the rules and general principles concerning mechanisms for control by Member States of
the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Pag. 48
(c) number of websites and/or national planters’ guides containing information on where
to best plant FRM;
(d) quantities of FRM per genera and species imported from third countries under Union
equivalence;
(e) penalties imposed pursuant to Article 29.
The Commission shall, by means of implementing acts, specify the technical formats for the
report provided for in paragraph 1 of this Article. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 27(2).
Article 29
Penalties
1. Member States shall lay down the rules on effective, proportionate and dissuasive
penalties for infringements of this Regulation and shall take all measures necessary
to ensure that they are implemented. Member States shall, without delay, notify the
Commission of those rules and measures and of any subsequent amendment affecting
them.
2. Member States shall ensure that financial penalties for violations of this Regulation,
perpetrated through fraudulent or deceptive practices, reflect, in accordance with
national law, at least either the economic advantage for the professional operator or,
as appropriate, a percentage of the professional operator’s turnover.
Article 30
Amendments of Regulation (EU) 2016/2031
Regulation (EU) 2016/2031 is amended as follows:
(1) in Article 37, paragraph 4 is replaced by the following:
‘4. The Commission shall, by means of an implementing act, where appropriate,
set out measures to prevent the presence of Union regulated non-quarantine
pests on the plants for planting concerned, as referred to in Article 36, point (f),
of this Regulation. Those measures shall, where appropriate, concern the
introduction into and the movement within the Union of those plants.’;
(2) in Article 83, the following paragraph is added:
‘5a. In the case of plants for planting produced, or marketed, as categories source identified, selected, qualified or tested, as referred to in Regulation (EU)
…/…*+, the plant passport shall be included, in a distinct form, in the official
label produced in accordance with the respective provisions of that Regulation.
Where this paragraph applies,
(a) the plant passport for movement within the Union territory shall contain
the elements set out in Parts E and F of Annex VII to this Regulation;
(b) the plant passport for introduction into, and movement within, a
protected zone shall contain the elements set out in Part H of Annex VII
to this Regulation.’;
______________________
Pag. 49
* Regulation (EU) .../... of the European Parliament and of the Council of ... …
(OJ ...).’;
+ OJ: Please insert in the text the number of this Regulation and institutions and
insert the number, date, title and OJ reference of this Regulation in the
footnote.
(3) Annex VII is amended in accordance with Annex VII to this Regulation.
Article 31
Amendments of Regulation (EU) 2017/625
Regulation (EU) 2017/625 is amended as follows:
(1) in Article 1(2), the following point is added:
‘(l) production and marketing of forest reproductive material.’;
(2) in Article 3, the following point is added:
‘(52) ‘forest reproductive material’ means material as defined in Article 3(1) of
Regulation (EU) …/… of …*+
______________________
* Regulation (EU) .../... of the European Parliament and of the Council of ... …
(OJ ...).’;
+ OJ: Please insert in the text the number of this Regulation and
institutions and insert the number, date, title and OJ reference of this
Regulation in the footnote.
(3) the following article is inserted after Article 22a:
‘Article 22b
Specific rules on official controls and for action taken by the competent authorities in
relation to forest reproductive material
1. Official controls to verify compliance with the rules referred to in Article 1(2),
point (l), shall include official controls on the production and marketing of
forest reproductive material, and on operators subject to those rules.
2. The Commission is empowered to adopt delegated acts in accordance with
Article 144 to supplement this Regulation by laying down rules for the
performance of official controls on forest reproductive material in order to
check compliance with Union rules referred to in Article 1(2), point (l),
applicable to those goods and for action taken by the competent authorities
following the performance of those official controls.
Those delegated acts shall lay down rules on:
(a) specific requirements for the performance of such official controls on the
production and marketing within, the Union of particular of particular
forest reproductive material subject to the rules referred to in Article
1(2), point (l), to respond to non-compliance with the Union rules on
forest reproductive material of a particular origin or provenance;
Pag. 50
(b) specific requirements for the performance of such official controls on the
activities of professional operators related to the production of particular
forest reproductive material subject to the rules referred to in Article
1(2), point (l), to respond to non-compliance with the Union rules on
forest reproductive material of a particular origin or provenance; and
(c) the cases where the competent authorities are to take one or more of the
measures referred to in Article 137(2) and Article 138(2) in relation to
specific non-compliances.
3. The Commission shall, by means of implementing acts, lay down rules on
uniform practical arrangements for the performance of official controls on
plant reproductive material in order to verify compliance with Union rules
referred to in Article 1(2), point (l), applicable to those goods and for action
taken by the competent authorities following such official controls on:
(a) uniform minimum frequency of such official controls, where a minimum
level of official control is necessary to respond to recognised uniform
risks of non-compliance with the rules on forest reproductive material of
a particular origin or provenance;
(b) frequency of official controls performed by competent authorities on
operators authorised to issue official labels under official supervision in
accordance with Article 16(1) of Regulation (EU) …/…*+
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 145(2).
______________________
* Regulation (EU) .../... of the European Parliament and of the Council of
... … (OJ ...).’
+ OJ: Please insert in the text the number of this Regulation and
institutions and insert the number, date, title and OJ reference of this
Regulation in the footnote.
CHAPTER IX
FINAL PROVISIONS
Article 32
Repeal of Directive 1999/105/EC
Directive 1999/105/EC is repealed.
References to that repealed act shall be construed as references to this Regulation and shall be
read in accordance with the correlation table in Annex VIII.
Article 33
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
It shall apply from … [3 years after the date of entry into force of this Regulation].
Pag. 51
It shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament For the Council
The President The Presiden