EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 6.5.2013  
COM(2013) 262 final 
2013/0137 (COD) 
  
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
On the production and making  available on the ma rket of plant repro ductive material 
(plant reproductive material law) 
(Text with EEA relevance) 
{SWD(2013) 162 final} 
{SWD(2013) 163 final}  EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
Plant reproductive material is a fundament al input for the productivity, the diversity, 
and the health and quality of agriculture,  horticulture and food and feed production 
and our environment. Forests cover a large area of the Union and fulfil multiple social, economic, environmental, ecologica l and cultural functi ons. The current EU 
legislation for making available on the market  of plant reproductive material is based 
on two main pillars, namely the registration of varieties/material and the certification 
of individual plant reproductive material lots of plant species as identified in the 
Directives ('EU listed species').  
The draft proposal consolidates and update s the legislation on marketing of plant 
reproductive material by repealing and replacing the following 12 Directives: 
Council Directive 66/401/EEC on the marketing of f odder plant seed, Council 
Directive 66/402/EEC on the marketing of cereal seed, C ouncil Directive 
2002/53/EC on the common catalogue of vari eties of agricultu ral plant species, 
Council Directive 2002/54/EC on the marke ting of beet seed, Council Directive 
2002/55/EC on the marketing of vegetabl e seed, Council Directive 2002/56/EC on 
the marketing of seed potatoes, Council Directive 2002/57/EC on the marketing of 
seed of oil and fibre plants, Council Directive 68/193/EEC on the marketing of 
material for the vegetative propagation of the vine, Council Dire ctive 1998/56/EC on 
the marketing of propagating material of  ornamental plants, Council Directive 
92/33/EEC on the marketing of vegetable propagating and planti ng material, other 
than seed, Council Directive 2008/90/EC on the marketing of fruit plant propagating 
material and fruit plants intended fo r fruit production and Council Directive 
1999/105/EC of 22 December 1999 on the marke ting of forest reproductive material. 
The majority of Council Directives for ma king available on the market of plant 
reproductive material have first been adopted between 1966 and 1971 and some 
Directives are more recent. The old Directives have been updated both frequently and substantially, creating the need for clarity and transparency. As a consequence of this history, the Directives are quite dive rse in the technical backgrounds they are 
based on, but also in their approaches, ranging  from official cont rols on products to 
official supervision of processes. In part icular, the product control is very demanding 
for competent authorities. 
Furthermore, the complexity and fragmentati on of the existing legislation is likely to 
perpetuate existing uncertainties and discre pancies in its implementation between the 
Member States. This creates an uneven play ing field for professional operators on the 
single market. There is a need to harmonise  implementation of the legislation, reduce 
cost and administrative burdens and support innovation. It is also important to adapt to the technical progre ss in plant breeding, and to the ra pid evolution of the European 
and global market of plant reproductive ma terial. All those needs make the update 
and modernisation of the legislativ e framework imperative. The aim of in situ 
conservation of agro-biodiversity should be further strengthened. In addition, the weak horizontal coordination with other EU legislation, policies a nd strategies is an 
obstacle to their more efficient implementati on. In the past years,  agricultural policy 
in the EU has come to be seen as strategi cally important for food security and safety, 
the nutritional value of food, the environm ent, biodiversity and climate change. 
"Sustainable intensification" and greeni ng of food crop production, in which yields EN 3   EN are increased without advers e environmental impact and w ithout the cultivation of 
more land, have become a central concern. Plant reproductive mate rial legislation is 
critically important for reaching this ai m. The EU Forest Strategy emphasises the 
importance of the multifunctional role of forest and its sustainable management. 
Coherence and synergies with the Plant Health Law concerning the plant health 
checks which are part of the plant reproduc tive material certification process or 
integration of general princi ples relating to official c ontrols embedded in Regulation 
(EC) No 882/2004 on official controls are needed. 
2. RESULTS  OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENTS 
The impact assessment of this proposal bui lds on the results of the evaluation of the 
EU legislation on the marketing of seed and plant propagating material (now plant 
reproductive material) that was carri ed out in 2007/2008 by the Food Chain 
Evaluation Consortium (FCEC), on the re sults of a study on variety registration 
conducted by the same consortium in the firs t half of 2010. It is furthermore based on 
a broad survey of all interest ed parties, in particular th e competent authorities in the 
Member States, private sector representatives  at EU and at national level, relevant 
international standard se tting bodies, non-government al organisations and the 
Community Plant Variety Office (CPVO). A number of Comm ission Horizontal 
Working Party meetings covering all the plant species were held in 2009-2011. In 
May 2011, four task forces created under the Hungarian presidency worked on specific topics. In addition, the Commissi on consulted the working group 'Seeds and 
Propagating Material' of the Advisory Group on the Food Chain, Animal and Plant 
Health on several occasions from 2009 – 2011. On 18 March 2009 an open conference "Ensuring Seed Availability in the 21st Century" was organised to 
present and discuss the evaluation results w ith different stakeholders. Finally, a web-
based stakeholder survey using an “Inter active Policy Making” (IPM) questionnaire 
to collect comments on an "Options a nd Analysis" paper was organised from 19 
April to 30 May 2011. It yielded 257 res ponses from a very wide range of 
stakeholder groups. 
The main objective of the consultations wa s to seek views on the provisions and 
application of existing legisl ation and the needs for change. Overall, stakeholders 
were satisfied with the pr inciples underlying the exis ting Directives, but supported 
the Commission's intention to revise the legislation. Room for improvement was in 
particular identified pertaini ng to legal simplification, cost reductions and efficiency 
gains, increased flexibility for professional operators, the level of harmonisation among Member States, the role of niche and emerging markets and the conservation 
of agro-biodiversity and plant genetic res ources. Maintaining the general principles 
of the current legislation – especially the pr ocedures for the regist ration of varieties 
and the pre-marketing certification of s eed lots – was strongly supported by a 
majority of stakeholders. In addition, concerning the EU legislation on forest 
reproductive material, the stakeholders reque sted to maintain the current approach. 
The Impact Assessment identified the fo llowing main axes along which the system 
has to change in order to be fit for th e changing economic, environmental, social, 
scientific circumstances: (i) Simplification of the basic legal acts (from 12 Directives to one Regulation), (ii) Cost recovery and improvement of th e effectiveness and 
efficiency of the system and (iii) Horizontal coordination with recent, already EN 4   EN adopted EU policies. Various ways – increased flexibilit y, deregulation or 
centralisation – are explored for improvi ng the efficiency of the system, while 
maintaining the assurances for high quality plant reproductive material, 
competitiveness and addressing new challenges such as biodiversity. Based on these 3 axes, 5 policy options were identified, where legal simplification and cost recovery are constant for all options. In the various options, issues regarding SMEs and micro-
enterprises have been addressed throughout, especially in order to ensure access for 
these enterprises to public services for th e execution of certain tasks they cannot 
perform themselves and to support and furt her develop their fl exibility to gain 
improved access to the plant reproductive mate rial market. Specific attention is given 
to trade-offs between transferring operati onal work and keeping of quality of plant 
reproductive material. 
The impact assessment concludes that no  single option succeeds in achieving the 
objectives of the review in an efficient, effective and coherent manner and suggests, 
in line with stakeholder opinion, a preferre d option which combines elements from 
option 2, 4 and 5. The proposal thus creates an environment providi ng legal security 
for professional operators and consumer s, guaranteeing high quality of plant 
reproductive material and securing compe titive advantage on the internal and the 
world markets. This combination aims at striking a balance between flexibility for professional operators (option 2 and 4) and biodiversity (option 4) and the necessary 
rigor in health and quality requirement (elements of option 2 and 5) for the fair 
functioning of the market and for mainta ining the quality and health of plant 
reproductive material. This is combined with  elements allowing minor crops or crops 
with particular uses low-bur den access to specific or small market segments, but with 
coupled minimum obligations ensuring trac eability, health and information to the 
consumer so that a level playing for a ll professional operators is established. 
3. LEGAL
 ELEMENTS  OF THE  PROPOSAL 
The aim of the proposal is to replace the existing 12 Directives by one single 
proposed Regulation.  
3.1. Part I – General provisions 
The scope of the proposed Regulation covers all types of plant reproductive material. 
The largest part of it covers, though, th e species currentl y regulated by the 
12 Directives (so called 'listed species'). However, to clarify and harmonise the existing approaches in the Member States on the other species, i.e. plant species not listed and thus not covered by the current Directives, also these species will be subject to some very basic rule s (see Part III,  Title III).  
In order to take into acc ount the needs of producers and the requirements of 
flexibility and proportionality, the Regulati on will not to apply to plant reproductive 
material intended for testing and scien tific purposes and intended for breeding 
(selection) purposes. In addi tion, it should not apply to material intended to or 
maintained in gene banks, organisations a nd networks of ex-sit u and in-situ or on 
farm conservation of genetic resources fo llowing national strategies on conservation 
of genetic resources. Furthermore, plant reproductive material exchanged in kind 
between two persons other than professional operators is excluded from the scope of 
the Regulation. 
As regards definitions, the main change is the introduction of a common term to 
cover all the plant reproductive material, either  in the form of seeds or other types of EN 5   EN plant propagating material. Plant reproductive material is defined to mean plants or 
parts of plant capable of and intended fo r producing or reproduc ing entire plants. 
This includes also young plants. All those t ypes of plant reproductive material are 
subject to common principles with regard to their production w ith a view to making 
available on the market and with regard to making them available on the market. 
3.2. Part II – Professional operators  
As under this Regulation the definition of operator does not incl ude private persons, 
the term 'professional operator' is used. Pr ofessional operators are defined by a single 
definition and shall be registered to ease the control activities. This register shall be combined with the register establishe d under [title of the new Plant Health 
Regulation]. Basic obligations will be introduced for professional operators 
concerning the identification of the plant re productive material th ey are producing or 
making available on the market, keeping of records, facilitatio n of controls and 
maintenance of the material. The traceabilit y of any plant reproductive material is 
ensured by the obligation for the professional operators to have information one step 
before and one step after their commercial activities. 
3.3. Part III – Plant reproductive material ot her than forest reproductive material 
Title I General provisions 
Definitions of variety and its maintenance, va riety with official de scription or variety 
with officially recognised de scription, clone as well as of the different marketing 
categories are laid down. 
Title II Production and making availabl e on the market of listed species 
In general, the basic approach on re gistration of varie ties/material and 
certification/inspection of lots before making available on the market will be 
maintained. However, more flexibility will be given to the prof essional operators so 
that they may decide to carry out the nece ssary examination for variety registration 
or inspections, sampling and analysis of plant reproductive materi al for certification 
under the official supervision of the compet ent authorities. In addition, secondary 
acts will be adopted setting out the specific requirements for the production and 
making available on the market of particular  species and their categories (pre-basic, 
basic, certified and standard material). This  is important to increase flexibility for 
changes due to technical and scientific developments and at the same time respecting 
proportionality and sustainability in regulatory approach. 
The requirements for making available on th e market of plant reproductive material 
may be summarised as follows:  
– it belongs to a variety or clone register ed in accordance the provisions of this 
Regulation;  
– it complies with the specific requiremen ts adopted for the marketing category 
concerned per genera and species;  
– it bears an official label for pre-basic,  basic or certified material, or an 
operator's label in case of standard material; 
– it complies with the handling requirements; 
– it complies with the requirements for certification and identification. EN 6   EN The obligation of variety registration shall not  apply to rootstocks  which do not fulfil 
the conditions of a variety. In addition, in order to introduce flexibility for future 
technical and scientific developments, hete rogeneous material, which does not fulfil 
the definition of a variety, could be ex empted under certain conditions from the 
requirement that that material belongs to a registered variety. Furt hermore, a specific 
derogation for niche market plant re productive material  is laid down.  
Certain genera and species of plant reproductive material , which are listed in the 
current Directives, should continue to be s ubject to enhanced requirements relating to 
their production and making available on the market (listed species). However, there 
is a need to set criteria to decide on these plant species. Genera or species of plants 
which represent a significant area and value of production, are produced and made 
available on the market by a significant num ber of professional operators or they 
contain substances requiring specific rule s to protect human, animal health or the 
environment should be included in the list.  
Plant reproductive material should only be produced and made available on the 
market as pre-basic, basic, certified or standard material, in  order to ensure 
transparency and informed choices for users.  Detailed criteria need to be established 
to decide which genera and plant species shall not be made available on the market as standard material to ensure enhanced quality and health, identity and traceability 
of plant reproductive material as we ll as food and feed security. Specific 
requirements should be adopted per genera and species for each of those categories. 
The requirements on identity, purity, health and other quality requi rements, labelling, 
lots, packaging including small packages, post-certification control tests, comparative tests and trial and mixtur es will continue to be applied.  
Derogations 
The existing permanent derogations on maki ng available on the market to a limited 
extent not-yet registered varieties for testing on farm and not finally certified 
material and authorisation of more st ringent national requirements should be 
maintained. This should also concern the important temporary derogations on 
emergency measures, temporary difficulties in supply and temporary experiments.  
Derogation on niche market plant reproductive material 
In addition, proportionate and sustainable ru les for small scale activities concerning 
plant reproductive material, wh ich is adapted to local c onditions, and made available 
on the market in small quantities, should be established. Such varieties should be 
exempted from the requirements on regist ration and making available on the market. 
This material is defined as niche market  plant reproductive ma terial. The exemption 
should concern e.g. farmer-breeders or gard ener-breeders whether being professional 
operators or not. However, some basic rules on labelling and traceability of the material should be laid down. In order to  prevent an abuse of the exemption the 
material should only be made available on th e market in a defined size of packages.  
Imports and exports 
The EU equivalence system is maintained as a basic condition for imports from third 
countries. However, exports are included in the scope of the Regulation. Exports 
should take place in line with  legislation, standards, code  of practice or any other 
legal or administrative procedure in pl ace in the importing third country. Where a 
bilateral or multilateral agreement between the Union and the third country exists, 
the exports from the Union shall comply w ith the agreement. Furthermore, in the EN 7   EN absence of the latter, an agreement c onducted between the professional operators 
shall apply.   
Title III Production and making available on the market of plant reproductive 
material belonging to non-listed genera or species  
Plant reproductive material not belonging to the listed genera and species shall also 
be subject to a few basic requirements with regard to its health status, fitness for 
purpose, appropriate reference to varieties, where applicable, and identification of the 
respective material and imports.  
Title IV Registration of varieties  in national and Union registers 
Variety registers The varieties, in order to be made avai lable on the market throughout the Union, 
shall be included in a national register or in the Union regi ster via direct application 
procedure to the CVPO. CPVO will keep  the updated information on all plant 
varieties that can be made available on the market in the Union, including the 
varieties registered in national regi sters (Union plant variety database). 
For new improved varieties the basic requ irement of DUS (distinct, uniform and 
stable) will be maintained. The uniformity  examination should take into account the 
type of variety and type of reproducti on. In addition, by secondary act it can be 
decided for which plant species additiona l requirements on value for cultivation and 
use (VCU) can be laid down. The Member St ates shall adopt more detailed criteria 
for the VCU examination of these plant species as regards their yield, quality characteristics, resilience and suitability for low input production systems including 
organic production. Thus, given the specific  characteristics re quired for organic 
farming, the methodology and requirements established for variety examination 
should take due account of the specific needs. 
Rules on a sustainable value for cultivation will be laid down and harmonised in the 
EU by adopting specific requirements conc erning resistance to specific pests, 
reduced need for input of resources, decreas ed content of undesirable substances or 
increased adaptation to divergent agro-climatic environment. This is an important tool to guide the breeding proce ss to a more sustainable direction. 
If a variety has been granted a Union Pl ant Variety Right pursuant to Regulation 
(EC) No 2100/1994, or pursuant to national rules, that va riety should be deemed to 
be distinct, uniform and stable and to ha ve a suitable denomination for the purposes 
of variety registration under this Regulation. 
The basic principle of the use of a singl e denomination throughout the Union for one 
variety is kept. In certain specific cases synonyms will be allowed. The CPVO is best 
made available to have an overview of applicable denominations of varieties 
throughout the Union. Therefore, and in or der to ensure cohe rence regarding the 
assignment of denominations throughout th e Union, the competent authorities should 
consult CPVO to check a denomination, before the respective variet y is registered in 
a national variety register.  
The Regulation establishes the detailed requirements for the variety registration 
procedure regarding conditions for re gistration, submission and content of 
applications, formal and technical examin ations, examination reports, decisions on 
registration, period of validity and its renewal, revocation/deletion of registration and EN 8   EN maintenance of varieties. For coherence, the same rules shall also apply to direct 
variety applications to the CPVO for regi stration in the Union variety register.  
Specific provisions are set out on the regi stration in the Union variety register and 
with regard to the possibility for the applicant to launch an appeal against a CPVO decision. Such provisions are not laid down fo r the registration in the national variety 
registers, because they are subject to national administ rative procedures. 
A new obligation for each national variety examination centre to be audited by the 
CPVO will be introduced with the aim to en sure the quality and harmonisation of the 
variety registration process in the Union. The examination centre of the professional 
operators will be audited and approved by th e national competent authorities. In case 
of direct application to the CPVO it will a udit and approve the examination centres it 
uses for variety examination. 
The competent authorities and the CPVO shou ld charge fees for the processing of 
applications, the formal and technical examinations including audits, variety 
denomination, and the maintenance of the va rieties for each year for the duration of 
the registration. Therefore, ha rmonised rules for those fees should be set out in this 
Regulation. The general principle of cost re covery shall prevail. However, the micro-
enterprises shall be exempted from fees to fulfil the Commission's commitment to lower the burden on very small businesses, in line with its new policy on minimizing 
regulatory burden for SMEs and adapting EU regulation to th e needs of micro-
enterprises. Moreover, the f ee for registration of varietie s with officially recognised 
description and heterogeneous material sha ll be reduced in a manner to ensure that 
the fee does not constitute a barrier to th e registration of the variety or material 
concerned.  
Old traditional varieties 
Concerning old varieties, such  as conservation varieties (i ncluding landraces), or so 
called 'amateur varieties', less stringent re quirements should continue to be laid down 
in view of promoting their on farm conser vation and use as curre ntly regulat ed under 
the Directives 2008/62/EC and 2009/145/EC. The varieties will continue to be 
registered, however, on the basis of an 'offi cially recognised description' which shall 
be recognised – but not produced – by the comp etent authorities. Fo r that description 
DUS examination is no longer obligatory. The officially recognised description shall 
only describe the specific characteristics of the plants and parts of plants which are 
representative for the variety concerned a nd make the variety identifiable, including 
the region of origin. This de scription can be ba sed on an old official description of 
the variety, description produced at the time by e.g. a scientific, academic body or 
organisation. The accuracy of its content could be supported by previous official inspections, unofficial examinations or know ledge gained from practical experience 
during cultivation, reproduction and use. The current quan titative restrictions are 
abolished. The users are informed about the material by a label indicating that this variety is identified by an officially rec ognised description and the region of origin. 
Plant reproductive material belonging to  those varieties should only be made 
available on the market as standard material. 
3.4. Part IV – Production and making available on the mark et of forest reproductive 
material 
The EU legislation sets a specific appro ach including specific terminology on forest 
reproductive material. Therefore, for this area a separate part is laid down in which EN 9   EN the current basic approach is kept. The re quirements for forest reproductive material 
concern approval of basic material, inclus ion in national register and Union list, 
master certificate, marketing categories, lots, mixtures, labelling, packaging and 
establishment of the conditi ons of EU equivalence fo r imports. In addition, the 
following derogatory rules need  to be set: authorisation of more stringent national 
requirements, prohibition to make available to end user specified forest reproductive 
material, rules concerning temporary difficu lties in supply and rules concerning 
temporary experiments. 
3.5. Part V – Procedural provisions 
Rules for delegated acts and the committee procedure are laid down. 
3.6. Part VI – Final provisions 
The Regulation (EC) NO 2100/94 on Commun ity Variety Rights is amended as 
regards the name and role of CPVO. The na me of the agency is amended to follow 
the recommendations of the EU inter-in stitutional working group to 'European 
Agency on Plant Varieties' (EAPV). The mi ssion of CPVO is exte nded to the area of 
variety registration, in partic ular the management of Uni on variety register and the 
registration of plant varieties via direct  application procedure to the CPVO. In 
addition, a number of tasks are attributed  to the CPVO within its new mission on 
offering recommendations on variety de nominations, database on reference 
collections of varieties, harmonisation of tec hnical examination of varieties, audits of 
technical examination centres, advisory tasks, training and technical support. 
The necessary rules on penalties are laid down.  
3.7. Part VII – Union competence, subsidiarity and legal form  
The plant reproductive material legislative framework is based on the Treaty on the 
Functioning of the European Union (TFE U) Article 43 implementing the Common 
Agricultural Policy (CAP). The objectives of  that policy are to increase agricultural 
productivity, to ensure a fair  standard of living for th e agricultural community, to 
stabilise markets, to assure the availability  of supplies and to ensure that supplies 
reach consumers at reasonable prices. Requirements with regard to the sustainability of agriculture have been integrated thr ough the successive revisions of the CAP. The 
Lisbon Treaty qualifies agri culture as shared competen ce between the EU and its 
Member States. It is obvious , however, that to a very large extent all fields of 
agricultural activity as well as ancillary  activities upstream and downstream have 
been regulated at the EU level. This means that legislation is predominantly a role for 
the institutions of the European Union. 
The proposal takes the form of a Regulation of the European Parliament and of the 
Council. Other means would not be appr opriate because the objectives of the 
measure can be achieved most effici ently by fully harmonised requirements 
throughout the Union, ensuring free moveme nt of plant reproductive material. 
4. BUDGETARY
 IMPLICATION 
The financial appropriations for implemen ting the Regulation up to 31 December 
2020 are being presented in the Regula tion on laying down provisions for the 
management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant hea lth and plant reproductive material. EN 10   EN 5. OPTIONAL  ELEMENTS EN 11   EN 2013/0137 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
On the production and making available on the market of plant reproductive material 
(plant reproductive material law) 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL 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 Commission, 
After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the Eur opean Economic and Social Committee,  
Having regard to the opinion of the Committee of the Regions,  
Acting in accordance with the or dinary legislative procedure
1, 
Whereas: (1) The following Directives set out rules fo r the production and marketing of seeds and 
propagating material of agricultural crops , vegetables, vine, fruit plants, forest 
reproductive material and ornamental plants: 
(a) Council Directive 66/40 1/EEC of 14 June 1966 on the marketing of fodder 
plant seed
2; 
(b) Council Directive 66/40 2/EEC OF 14 June 1966 on the marketing of cereal 
seed3; 
(c) Council Directive 68/193/ EEC of 9 April 1968 on the ma rketing of material for 
the vegetative propagation of the vine4; 
(d) Council Directive 98/56/EC of 20 Ju ly 1998 on the marketing of propagating 
material of ornamental plants5; 
(e) Council Directive 1999/105/EC of 22 December 1999 on the marketing of 
forest reproductive material6; 
                                                 
1 Position of the European Parliament  of … and position of the Council at first reading of ... Position of 
the European Parliament of ... an d decision of the Council of .... 
2 OJ L 125, 11.7.1966, p. 2298.  
3 OJ L 125, 11.7.1966, p. 2309. 
4 OJ L 93, 17.4.1968, p. 15. 
5 OJ L 226, 13.8.1998, p. 16. 
6 OJ L 11, 15.1.2000, p. 17. EN 12   EN (f) Council Directive 2002/53/ EC of 13 June 2002 on the common catalogue of 
varieties of agricultural plant species7; 
(g) Council Directive 2002/54/EC of 13 J une 2002 on the marketing of beet seed8; 
(h) Council Directive 2002/55/EC of 13 J une 2002 on the marketing of vegetable 
seed9; 
(i) Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed 
potatoes10; 
(j) Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil 
and fibre plants11; 
(k) Council Directive 2008/72/EC of 15 Ju ly 2008 on the marketing of vegetable 
propagating and planting ma terial, other than seed12; 
(l) Council Directive 2008/90/EC of 29 Se ptember 2008 on the marketing of fruit 
propagating material and fruit pl ants intended for fruit production13.  
(2) The basic objective of the above Directiv es is sustainable agri cultural, hor ticultural 
and forestry production. In order to en sure productivity, the health, quality and 
diversity of plant reproductive material is  of outmost importance for agriculture, 
horticulture, food and feed secu rity, and the economy in gene ral. Moreover, to ensure 
sustainability, legislation should take acc ount of the need to meet consumers' 
expectations, to ensure the adaptability  of production to manifold agricultural, 
horticultural and environmental conditions, to  face the challenges of climate change 
and to foster the protection of agro-biodiversity. 
(3) Evolution in the areas of agriculture, hor ticulture, forestry, plant breeding and making 
available on the market of plant reproductive  material has shown that the legislation 
needs to be simplified and further adapted to the developments of the sector. Therefore, the above Directives should be replaced by a single Regulation on the 
production, with a view to ma king available on the market , and the making available 
on the market, of plant reproducti ve material within the Union. 
(4) Plant reproductive material, should be de fined in a comprehensive manner, including 
all plants capable of, and intended for, pr oducing (including reproducing at any further 
stage of production) entire plants. This Re gulation should, therefore, cover seeds, as 
well as all other forms of plant at any gr owth stage, intended for and capable of 
producing entire plants.  
(5) This Regulation should also cover plant re productive material used for the production 
of agricultural raw materials intended for industrial purposes, since that material 
represents a major part of several sectors and should fulfil certain quality standards. 
(6) In order to determine the scope of the se veral provisions of th is Regulation it is 
necessary to define the concepts of “pro fessional operator” and “making available on 
the market”. In particular, in view of th e marketing developments of the sector, the 
                                                
 
7 OJ L 193, 20.7.2002, p. 1. 
8 OJ L 193, 20.7.2002, p. 12. 
9 OJ L 193, 20.7.2002, p. 33. 
10 OJ L 193, 20.7.2002, p. 60. 
11 OJ L 193, 20.7.2002, p. 74. 
12 OJ L 205, 1.8.2008, p. 28. 
13 OJ L 267, 8.10.2008, p. 8. EN 13   EN definition of 'making available on the market' should be as wide as  possible to ensure 
all forms of transactions of  plant reproductive material. Th at definition should include 
inter alia  persons concluding sales through distan ce contracts (e.g. electronically) and 
persons who collect basic forest material.  
(7) Given the needs of produ cers and the requirements for flexibility and proportionality, 
this Regulation should not appl y to reproductive ma terial intended solely for testing, 
scientific and breeding purpos es, to gene banks, organisatio ns and networks devoted to 
the exchange and conservati on of genetic resources (inc luding on-farm conservation), 
or to reproductive material exchanged in kind between persons other than professional 
operators. 
(8) Directive 94/62/EC of 20 December 1994 on packaging and packaging waste14, 
Regulation (EC) No 338/97/EC of 9 Decem ber 1996 on the protection of species of 
wild fauna and flora by regulating trade therein15, 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/EEC16, Regulation (EC) No 1829/2003 of  the European Parliament 
and of the Council of 22 September 2003 on genetically modified food and feed17, 
Regulation (EC) No 1830/2003 of the European  Parliament and of the Council of 22 
September 2003 concerning the traceability a nd labelling of genetically modified 
organisms and the traceability of food a nd feed products produced from genetically 
modified organisms and am ending Directive 2001/18/EC18 and Regulation (EU) No 
…/… [ Office of publications, please add number of Regulation on protective measures 
against pests of plants ], should also apply for the pr oduction and making available on 
the market of plant reproductive material. 
(9) In order to ensure transparency and more effective controls on the production and 
making available on the market of plant repr oductive material, professional operators 
should be registered. Howeve r, in order to reduce th e administrative burden for 
professional operators, by allowing them to regi ster only once in a si ngle register, it is 
appropriate that they register in the public  registers established by the Member States 
pursuant to Regulation (EU) No …/… ( Office of Publication, please insert number of 
Regulation on protective measur es against pests of plants ).  
(10) Basic obligations should  be introduced for professi onal operators active in the 
production and making available on the market of plant reproductive material area to 
ensure the proper applica tion of this Regulation. 
(11) Experience has shown that the reliability  and quality of reproductive material made 
available on the market can be jeopardised where it is impossible to trace reproductive 
material not complying with applicable standa rds. It is therefore necessary to establish 
a comprehensive system of traceability al lowing withdrawals to be undertaken or 
information to be given to consumers or competent authorities. For that reason, the 
keeping of the necessary information and r ecords on transfers from and to professional 
users should be mandatory. On the basis of the principle of proportionality, that rule 
should not apply in case that supply is part  of making available on the market in retail. 
                                                 
14 OJ L 365, 31.12.1994, p. 10–23 
15 OJ L 61, 3.3.1997, p. 1–69 
16 OJ L 106, 17.4.2001, p. 1–39 
17 OJ L 268, 18.10.2003, p. 1–23 
18 OJ L 268, 18.10.2003, p. 24–28 EN 14   EN (12) Certain genera and species of plant re productive material s hould be subject to 
enhanced requirements concerning their production and making available on the 
market due to their increased economic, h ealth or environmental importance. That 
importance should be determined through th e area or value of production of those 
genera or species, the number  of professional operators or  the content of substances 
which present a potential risk for health or the environment. The majority of those genera and species is currently regulated by the above Directives. Those genera and 
species should be inserted in a specific li st (hereinafter: 'listed genera and species'). 
(13) In order to ensure transparency and enable informed choices by consumers, plant 
reproductive material belonging to listed ge nera and species should only be produced 
or made available on the market under pred efined categories. Those categories should 
reflect different quality levels and produc tion stages and be named “pre-basic”, 
“basic”, “certified” and “standard”,  
(14) In order to ensure the widest possible availability of  plant reproductive material and 
choices by its users, professional operators should, in principle, be able to make 
available on the market plant reproductive material belonging to  listed genera or 
species under any of the categories. Howe ver, in order to ensure food and feed 
security, and to achieve a high level of identity, quality a nd health of plant 
reproductive material, plant reproductive materi al should not be made  available on the 
market as standard materi al if the certificat ion costs are proportionate to those 
objectives.  
(15) Plant reproductive material belonging to varieties with officially recognised 
description, as well as heterogeneous materi al and niche market material, should be 
subject to minimum requirements. Therefore,  such material should in all cases be 
produced and made available on the ma rket only as standard material. 
(16) In order to allow for informed choices by users concerning its identity and 
characteristics, plant reproductive materi al belonging to listed genera and species 
should only be produced and made available on  the market if it belongs to varieties 
registered in national variety register s or in the Union variety register. 
(17) In order to facilitate ad aptation to developments in pl ant breeding, and to possible new 
techniques, heterogeneous plant reproducti ve material, which does not fulfil the 
definition of a variety in the meaning of this Regulation, should be allowed to be 
produced or made available on the market, under certain conditions , without belonging 
to a registered variety, and even if it does not comply with the requirements 
concerning registration of varieties, namely di stinctiveness, uniformity or stability, or 
the requirements concerning the satisfactory va lue for cultivation or those concerning 
the sustainable value for cultivation. The regi stration of such material should take into 
account its contribution to increase the geneti c variability of agri cultural crops, the 
genetic resource basis and biodive rsity in the Union, as well as  to the sustainability of 
agriculture and thus  to the adaptation to climat e change. The methodology for the 
registration should particularly take into ac count those specific ch aracteristics and it 
should be based on the minimum possible bur den for operators who wish to register 
such material. It would also be appropriat e and proportionate to exempt from the same 
requirement rootstocks, as they have a sign ificant commercial and practical value for 
the sectors where they are used, but they fr equently do not fulfil the definition of a 
variety. 
(18) Rules should be set out for the certificati on of plant reproductive material, as well as 
for the activities aiming at verifying the reliability of certification at the post-EN 15   EN certification stage, to ensure the fulfilmen t of the applicable quality requirements. 
Those rules should be adapted to the t echnical and scientif ic developments.  
(19) The quality requiremen ts and certification scheme s should take into account 
international recommendations, such as the Seed Scheme Rules and Regulations of the 
Organisation for Economic Co-operation an d Development (OECD), the seed potato 
standards of the United Nations Economic  Commission for Europe (UNECE) and the 
rules on sampling and testing of the Interna tional seed testing a ssociation (ISTA).  
(20) Given the thresholds established for the presence of quality pests by Regulation (EU) 
No …/… ( Office of Publication, please insert  number of Regulation on protective 
measures against pests of plants ) on protective measures against pests of plants19, it is 
appropriate to establish detailed inspecti on and examination procedures leading to a 
single certification as regards compliance wi th the requirements adopted pursuant to 
this Regulation and to Regulation (EU) No. .../… ( Office of Publication, please insert 
number of Regulation on protective measures against pests of plants ). 
(21) In order to ensure the maximum possible purity of the material and the homogeneity of 
production, plant reproductive mate rial belonging to listed ge nera or species should be 
kept in separate lots. 
(22) In view of the diversity of plant repr oductive material, profe ssional operators should 
have the option to produ ce and make available on th e market plant reproductive 
material in the form of individual pl ants, packages, containers or bundles. 
(23) Rules should be adopted fo r the labelling of plant repr oductive material of listed 
genera or species to ensure the appropriate id entification of that material. In the case of 
material of the categories subject to certificat ion, the label (hereinafter: 'official label') 
should be produced and affixed by authoris ed professional operators and under the 
official supervision of the competent au thorities. However, and since certain 
professional operators may not have the re sources to carry out the certification 
activities and issue official labels, it shoul d be provided that official labels may be 
issued by competent authorities upon request of professional operators. 
(24) For the preservation of th e natural environment in the c ontext of the conservation of 
genetic resources, it is desirable to allow the mixture of plant reproductive material 
belonging to listed genera or species with non-listed genera or species. Those mixtures 
should be permitted only if their composition is  naturally linked to a certain region. In 
order to ensure transparency  and better control concerning the quality of the mixtures 
concerned, the production and making availa ble on the market of those mixtures 
should be subject to the authorisat ion by the competent authorities. 
(25) Rules should be adopted for the import of plant reproductive materi al of listed genera 
or species into the Union, only allowing th e import of plant reproductive material 
fulfilling the same production and quality re quirements as for material produced and 
made available on the market in the Union.  
(26) To ensure flexibility, and facilitate ad aptation of the professi onal operators and the 
markets to specific circumstances, or in cas es of temporary supply difficulties, it is 
appropriate to provide for certain derogations from th e general rules of this 
Regulation. Those derogations should be gr anted under specific conditions to avoid 
                                                 
19 ( Office of Publication, please insert OJ reference number of Regulation on protective measures against 
pest of plants ). EN 16   EN abuses and to ensure that the overall purpos es of this Regulati on are respected. They 
should concern plant reproductive material be longing to varieties, the registration of 
which is pending, plant reprodu ctive material which is no t finally certified or not 
certified as complying with applicable germination requirements. The possibility 
should also exist to adopt emergency measur es to address risks for human, animal and 
plant health, and the environment. 
(27) Plant reproductive materi al which is made available on the market only in limited 
quantities by small producers (“niche market plant reproductive material”) should be 
exempted from the requirement of belonging to  a registered variet y. That derogation is 
necessary to prevent undue constraints to the making available on the market of plant 
reproductive material, which is of lesser comm ercial interest, but is important for the 
maintenance of genetic diversity. However, it should be ensured that that derogation is 
not regularly used by a wide range of pr ofessional operators and it is only used by 
professional operators which cannot afford the costs and admini strative burden of 
variety registration. This is important to avoi d abuses of that derogation and to ensure 
the application of the rules of this Regulati on. Therefore, niche mark et material should 
only be made available on the market by professional operators employing a small number of persons and with  a small annual turnover.  
(28) It is desirable to orga nise temporary experiments for the purpose of seeking improved 
alternatives to any measures adopted for listed genera or sp ecies. In the organisation of 
those experiments the evolution of technique s relating to the production and control of 
plant reproductive material s hould be taken into account. 
(29) Exported plant reproductive material of listed genera or species to third countries 
should comply with the rules on plant reproductive material produced and made available on the market in the Union, unle ss the material concerned is subject to 
bilateral or multilateral agreements or rules of third countries.  
(30) Basic requirements should be set for plant reproductive mate rial not belonging to 
listed genera or species, to ensure minimum quality and identification standards for 
their production and making available on the market.  
(31) In order to ensure that  all varieties have access to registration and are subject to 
common rules and conditions rules should be  established for th e registration of 
varieties and should apply to vari eties of listed genera or spec ies as well as to varieties 
of non-listed species.  
(32) Experience so far has shown that some breeders are interested in making available on 
the market their varieties in the entire Union market, or in the bigger part of it. It is 
therefore appropriate to offer the breeders the option of register ing their varieties 
either in a national variety register or in a Union variety re gister. The task of 
establishing , publishing and updating the Union variety register should be assigned to 
the European Agency on Plant Varieties (her einafter: 'the Agency'), previously titled 
'Community Plant Variety Office' as established pursuant to Article 4 of Regulation (EC) No 2100/1994 of the Council, which is currently in charge of granting plant 
variety rights. The activities of the Agency  should thus cover all aspects of plant 
variety management.  
(33) Varieties should, in principl e, be registered on the basis of an official description 
produced by a competent authority or the Agency. However, in order to reduce the 
burden for the competent authorities and th e Agency and ensure flexibility, it is EN 17   EN appropriate to provide for the possibility that the examinations necessary to produce 
the official description may also be carried out by the applicants. 
(34) Further to the basic registration require ments, varieties bel onging to species with 
particular importance for the development of  agriculture and horticulture in the Union 
should be subject to the a dditional requirements ensuring satisfactory and sustainable 
value for cultivation or use.  
(35) The requirements ensuring sustainable valu e for cultivation shoul d be established at 
Union level in order to s upport sustainable development,  direct plant breeding and 
meet breeders', producer and consumer demands  concerning that type of development. 
The requirements ensuring satisfactory valu e for cultivation and use may be only 
developed by Member States according to  their agro-climatic and agricultural 
conditions. Therefore, the respective varietie s should only be registered in the national 
variety registers. The requirements ensuring satisfactory value for cultivation and use should concern yields and quality characteri stics. When Member States develop and 
apply such requirements, they should consid er the constraints characterising specific 
agricultural management practices. In partic ular, they should duly take into account 
the specific needs of organic farming as regards resilience and low input conditions. 
(36) In the context of the Conve ntion on Biological Diversity to  which the Union is a party, 
the Union has committed to maintain the gene tic diversity of cultivated plants, and of 
wild relatives, and to minimise genetic erosion. That commitment complements the 
objective of the Union to halt biodivers ity loss by 2020. In that  context, certain 
varieties should be allowed to be produced  and made available on the market even if 
they do not comply with the requirements concerning distinctiveness, uniformity or 
stability, to ensure their c onservation and sustainable use and thus contribute to the 
sustainability of agriculture and the adapta tion to climate change. Therefore, those 
varieties should only be registered on the ba sis of an officially recognised description. 
(37) However, the varieties regi stered on the basis of an o fficially recognised description 
should be produced in the re gion where they have been  historically grown and 
adapted, to ensure their authenticity and their added value for the conservation of 
genetic diversity and the prot ection of the environment. Th erefore, they should only be 
included in national variety re gisters. For the same reason, those varieties should have 
been available on the market and/or collected e.g. in gene banks before the entry into force of this Regulation, or, should have b een deleted for more than five years from 
the national variety register or Union variety register, in case  they have been registered 
there on the basis of a technical examinati on concerning their distinctness, uniformity 
and stability. 
(38) Rules should be established concerning the procedures for the registration of varieties 
and clones in the national variety registers to ensure  uniform conditions for all 
applications and a transparent fram ework for all interested parties. 
(39) Certain varieties which are naturally ad apted to the local and regional conditions and 
threatened by genetic erosion, or which have no intrinsic value for commercial crop production but have been developed for growing under particul ar conditions, are 
already accepted in national catalogues, lists or register s of varieties pursuant to 
Article 3 of Directive 20 08/62/EC of the Commission of 20 June 2008 providing for 
certain derogations for acceptance of agricu ltural landraces and varieties which are 
naturally adapted to the local and regional conditions and threatened by genetic EN 18   EN erosion and for marketing of seed and seed  potatoes of those la ndraces and varieties20, 
and pursuant to Article 3(1)  of Directive 2009/145/EC of the Commission of 26 
November 2009 providing for certain dero gations, for acceptance of vegetable 
landraces and varieties which ha ve been traditionally grown in particular localities and 
regions and are threatened by genetic eros ion and of vegetable varieties with no 
intrinsic value for commercial crop pr oduction but developed for growing under 
particular conditions and for marketing of  seed of those landraces and varieties21. 
Those varieties have not been subject to complete technical examination concerning 
their distinctiveness, uniformity or stabil ity. It is therefore appropriate that those 
varieties be registered dire ctly in the national variety registers without any further 
proceedings as varieties with an o fficially recognised description.  
(40) The Union variety register should also in clude all varieties that are registered in the 
national variety registers. In this way, it will be ensured that the Union variety register offers a transparent over view of all varieties re gistered in the Union.  
(41) Rules should be adopted for the regist ration of varieties and clones in the Union 
variety register. For the purpos es of consistency, those ru les should be similar to the 
rules on registration in na tional variety registers. 
(42) The competent national authorities and the Agency should charge fees for the 
processing of applications, the formal and t echnical examinations and for each year of 
the registration period. This would be necessa ry to ensure the necessary resources for 
the overall system of registration of varietie s, and that the main beneficiaries of that 
registration bear the costs for the functio ning of that system. Rules concerning the 
fixing of those fees should be set out in this Regulation. 
(43) In order to facilitate the registration of varieties which serve at combating genetic 
erosion in the Union, Member States shoul d apply a reduced fee for varieties with 
officially recognised descrip tion and for heterogeneous ma terial. Such reduced fees 
should be sufficiently low as not to constitu te a deterrent or a ba rrier to the making 
available on the market of those varietie s. In order to provide support to micro-
enterprises, they should be fully exempted from the payment of fees. 
(44) In order to protect the commercial intere sts and intellectual property of professional 
operators, the results of the examination and the description of  the genealogical 
components should be treated as  confidential, if the breede r so requests. For the sake 
of transparency, all descriptions  of varieties listed in the na tional variety re gisters or in 
the Union variety register shoul d be made publicly available. 
(45) Forests cover a large area of the Uni on and fulfil social, economic, environmental, 
ecological and cultural functions . There is, therefore, a need for specific approaches 
and actions for the different types of forest s, considering the wide range of conditions 
characterising the forests in the Union. 
(46) Forest reproductive material of tree speci es and artificial hybr ids which are important 
for forestry purposes should be  genetically suited to lo cal conditions and of high 
quality. The conservation and enhancement of  biodiversity of fore sts, including the 
genetic diversity of the trees, are essen tial to sustainable forest management. 
                                                
 
20 OJ L 162, 21.6.2008, p. 13–19. 
21 OJ L 312, 27.11.2009, p. 44–54. EN 19   EN (47) Requirements should be set for forest re productive material as regards basic material, 
categories under which the material may be made available on the market, lots, labelling, small packages, to ensure the a ppropriate quality and marketing standards, 
and to adapt to the technical and scie ntific developments of the sector. 
(48) In order to ensure flexibility and adapta tion to particular circ umstances, derogations 
should be provided, under conditions, for the production and making available on the 
market of forest reproductive material . Those derogations should concern the 
possibility for Member States to adopt mo re stringent requirements, the case of 
temporary difficulties of supply, the need of making seed rapidly available on the 
market, the conduct of temporary experiments and the adoption of emergency measures. 
(49) In order to serve the interest of cons ervation and sustainable use of forestry plant 
genetic resources, Member States shoul d be allowed to adopt less stringent 
requirements on forest reproductive material which is naturally adapted to the local 
and regional conditions and th reatened by genetic erosion. 
(50) The competent authorities should charge fees for the registration/approval of basic 
forest material and the issuance of master certificates for the forest material derived 
from registered/approved basic forest materi al. This would be necessary to ensure the 
necessary resources for the ce rtification of forest reproduc tive material, and that the 
main beneficiaries of that certification bear  the respective costs. In order to provide 
support to micro-enterprises, they should be fully exempted from the payment of fees. 
The rules concerning those fees should be se t out in this Regulation, as they concern 
the effective production, regi stration and making available on the market of forest 
reproductive material. 
(51) Regulation (EC) No 2100/1994 needs to be amended to include va riety registration in 
the mission of the Agency and to amend its  former title 'Community Plant Variety 
Office'. 
(52) In order to ensure that the Annexes of this Regulation ar e adapted 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 amending th e Annexes of this 
Regulation. 
(53) In order to follow the te chnical and economic developments  of the sector, the power to 
adopt acts in accordance w ith Article 290 TFEU should  be delegated to the 
Commission in respect of listing the gene ra or species whose plant reproductive 
material may not be placed on the market as standard material.  
(54) In order to follow the te chnical and economic developments  of the sector, the power to 
adopt acts in accordance w ith Article 290 TFEU should  be delegated to the 
Commission in respect of setting out the plant reproductive material which may be 
produced and made available on the market w ithout belonging to a registered variety, 
and the requirements for its production and making available on the market. 
(55) In order to ensure that plant reproduc tive material of listed genera or species, and 
certain types of forest reproductive materi al, fulfils the highest possible identity, 
quality and health requirements, as appropr iate for the characteristics of the genera, 
species or categories concerned, the power to adopt acts in accordance with Article 
290 TFEU should be delegated to the Comm ission in respect of adopting production 
and quality requirements, and certification sche mes, for those genera  or species, and in 
respect of adopting quality requirements for making available on the market specific EN 20   EN parts of plants and planting stock of sp ecies and artificial hybrids of forest 
reproductive material.  
(56) In order to ensure  that plant reproductive material is made available on the market 
under conditions adapted to the specific charac teristics of particular genera or species 
to which it belongs, the power to adopt acts in accordance with Article 290 TFEU 
should be delegated to the Commission in respect of the maximum size, composition 
and identification of lots, and the requireme nts concerning small packages, of plant 
reproductive material belonging to pa rticular genera or species.  
(57) In order to adapt the rule s concerning the official labels  and operators' labels to the 
characteristics of certain types of plant re productive material, the power to adopt acts 
in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out additional rules concerning the label for specific categories and other groups of plant reproductive material , indications concerni ng a label number, 
indications of generations of  pre-basic, basic, certified  and standard material, the 
indication of variety types including intraspecific or interspecific hybrids, the 
indication of subdivisions of categories sa tisfying different conditions, in case of 
mixtures, the indication of the percentage  by weight of the various components by 
species and, where appropriate, by variety, and indications concerning the intended 
use of the material.  
(58) In order to ensure the ability of the pr ofessional opera tors to proper ly carry out a 
reliable certification of th e plant reproductive material concerned, the power to adopt 
acts in accordance with Article 290 TFEU s hould be delegated to the Commission in 
respect of setting out more detailed requi rements concerning th e qualification of 
professional operators and of the inspectors which may be entrusted with certification 
activities, suitability of premises and availabi lity of particular equi pment to be used by 
the professional operators and laboratories.  
(59) In order to ensure updated standards for th e official supervision of certification carried 
out by operators as appropriate for the characteristics of part icular genera or species, 
the power to adopt acts in a ccordance with Article 290 TF EU should be delegated to 
the Commission in respect of setting out more detailed requirements concerning the 
way competent authorities must supervise the certification.  
(60) In order to ensu re updated standards for post-cer tification as appropriate for the 
characteristics of particular genera or species, the power to adopt acts in accordance 
with Article 290 TFEU should be delegated to the Commission in respect of setting 
out requirements concerning proportion of samples to be submitted to tests and concerning testing procedures.  
(61) In order to ensure that  mixtures of plant reproductive material are produced and made 
available on the market pursuant to the a ppropriate quality requirements per genera 
and species, and in order to ensure informed choices for their users, the power to adopt 
acts in accordance with Article 290 TFEU s hould be delegated to the Commission in 
respect of adopting rules concerning the production and making available on the market of mixtures of plant reproductive ma terial belonging to different genera or 
species listed in Annex I, or different vari eties of those genera or species, and in 
respect of adopting rules concerning mixtur e of plant reproductiv e material belonging 
to genera or species listed in Annex I, with plant reproductive material belonging to 
genera or species not listed in Annex I. EN 21   EN (62) In order to ensure that plant reproductive material belong ing to varieties, registration 
of which is pending, is made available on th e market in a transparent manner and to a 
limited extent only, the power to adopt ac ts in accordance with Article 290 TFEU 
should be delegated to the Commission in  respect of setti ng out requirements 
concerning labelling of packages and the maximum authorised quantities which may 
be made available on the market fo r specific genera or species.  
(63) In order to ensure that niche market material is made available on the market in a 
limited and transparent manner, the power to adopt acts in accordance with Article 290 
TFEU should be delegated to the Commission in respect of setting out the maximum 
size of packages, containers or bundles, and requirements concerning traceability, lots, 
and labelling of the niche market material concerned.  
(64) It is important to ensure  that plant reproductive material  not finally certified, and seed 
not confirmed as complying with germin ation requirements, can be produced and 
made available on the market under partic ular conditions. Therefore, the power to 
adopt acts in accordance w ith Article 290 TFEU should  be delegated to the 
Commission in respect of se tting out specific rules for plant reproductive material 
concerning the packages, containers and bundles, rules on small packages and 
containers, the labelling of that material, the duration of period in which such seed may be made available on the market, and th e content of the prov isional analytical 
reports concerning germination. 
(65) It is important to ensure  that plant reproductive material  imported from third countries 
fulfils the requirements of this Regulati on. Therefore, the power  to adopt acts in 
accordance with Article 290 TFEU  should be delegated to the Commission, in respect 
of deciding whether plant reproductive material of specific genera, species οr 
categories produced in a third country, or pa rticular areas of a third country, fulfils 
requirements equivalent with those applicab le to plant reproductive material produced 
and made available on the market in the Union. 
(66) It is important to ensu re that the production and making available on the market of 
plant reproductive material of particular genera or species responds to increased 
requirements of the society concerning th eir agricultural performance and quality 
characteristics for processing. In orde r to follow the technical and economic 
developments of the sector, the power to adopt acts in accordance with Article 290 
TFEU should be delegated to the Commi ssion in respect of listing the genera or 
species with particular importance for the satisfactory and sustainable development of 
agriculture in the Union.  
(67) In order to ensure updated standards for th e registration of varieties as appropriate for 
the characteristics of genera or species w ith particular importance for the sustainable 
development of agriculture in the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to th e Commission in respect of setting out 
rules for the registration of varieties of those genera or species concerning resistance to 
pests, reduced need for input of specific resources, decreased content of undesirable 
substances and increased adaptation to divergent agro-climatic environment.  
(68) In order to ensure updated conditions for the suitability of variety denominations in 
particular cases, the power to adopt acts  in accordance with Ar ticle 290 TFEU should 
be delegated to the Commission in respect of  setting out rules concerning the relation 
of denominations to trade marks, their relation to geographical indications or 
designations of origin for agricultural produ cts, written consents of holders of prior 
rights to remove impediments to the suitabi lity of a denomination, specific criteria to EN 22   EN determine whether a denomination is misl eading or confusing, and the use of a 
denomination in the form of a code.  
(69) It is important to ensure  that plant reproductive materi al belonging to clones may only 
be produced and placed on the market if it  fulfils particular quality and health 
requirements, and also belongs to genera or  species which have a particular value for 
particular market sectors. Therefore, the power to adopt acts in accordance with 
Article 290 TFEU should be delegated to the Commission in respect of adopting quality and health requirements for clones of particular genera or species, and in respect of listing the genera or species, to which the clones must belong in order to be 
made available on the market. 
(70) In order to ensure that the information provided in the applicatio ns for registration of 
varieties remain up to date to the developmen ts of the sector, and is relevant to the 
particular features of the va rieties belonging to those gene ra or species, the power to 
adopt acts in accordance w ith Article 290 TFEU should  be delegated to the 
Commission in respect of setti ng out additional items to be included in th e application 
for particular genera or species.  
(71) In order to ensure update d standards for the audits by the Agency and the competent 
authorities of premises of technical exam inations and of the organisation of those 
examinations, the power to adopt acts in accordance with Article 290 TFEU should be 
delegated to the Commission in respect of setting out rules concerning those audits.  
(72) In order to ensure update d standards for the technical ex aminations of varieties, the 
power to adopt acts in  accordance with Article 290 TF EU should be delegated to the 
Commission in respect of setting out rules concerning obligations for the qualification 
and training of the staff of competent au thorities or the app licants, the equipment 
necessary to carry  out the technica l examination, the establishm ent of variety reference 
collections, the establ ishment of quality management systems, and the conduct of 
growing trials and laboratory tests fo r particular genera or species.  
(73) In order to ensure proportionate, fair and updated amounts for the fees to be paid by 
the applicants for the registra tion of a variety in the Uni on variety register, the power 
to adopt acts in accordance with Article  290 TFEU should be delegated to the 
Commission in respect of se tting out the amount of the fees to be paid by the 
applicant. 
(74) In order to ensure a comprehensive submi ssion of information for particular categories 
or species of forest reproductive material, the power to adopt acts in accordance with 
Article 290 TFEU should be delegated to th e Commission in respect of setting out 
conditions under which the operator's la bel be supplemented by another document 
produced by the professional operator. 
(75) In order to avoid risks in relation to quality and health of the forest reproductive 
material concerned, the power to adopt acts in accordance with Article 290 TFEU 
should be delegated to the Commission in respect of supplementing the requirements 
set out in this Regulation concerning cl ones and clonal mixtures, by determining the 
maximum number of years or the maximum number of ramets to which the approval of clones or clonal mixtur es should be restricted. 
(76) In order to ensure that the exemption of small quantities of seeds of forest reproductive 
material, from the information requirements concerning germination or viability, is applied in a proportionate manner, the power to adopt acts in acco rdance with Article 
290 TFEU should be delegated to the Comm ission in respect of setting out the EN 23   EN maximum quantities of those small quanti ties for particular types of forest 
reproductive material. 
(77) In order to ensure that the cost items for the fees char ged by the competent authorities 
on the registration of approved basic forest  material and the issuance of master 
certificates are appropriate to the conducte d work and updated, the power to adopt acts 
in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting out those items.  
(78) It is of particular importance that th e Commission carry out appropriate consultations 
during its preparatory work for the adoption of delegated acts, including at expert 
level. The Commission, when preparing and drawing-up delegated acts, should ensure 
a simultaneous, timely and appropriate tran smission of relevant documents to the 
European Parliament and to the Council. 
(79) Implementing powers should be conferre d on the Commission in order to ensure 
uniform conditions for the implementation of the provisions of this Regulation concerning the following: 
(a) authorisation of Member States to adopt more st ringent requirements than 
those adopted pursuant to this Regul ation concerning plant reproductive 
material of listed genera or species a nd forest reproductive material of listed 
species and artificial hybrids,  
(b) adoption of emergency measures,  
(c) authorisation of Member States to pe rmit, for a maximum period of one year, 
the production and making available on the market of plant reproductive 
material belonging to a variety of listed genera or species not yet included in a 
national variety register or  in the Union register,  
(d) authorisation of Member States to pe rmit, for a maximum period of one year, 
the making available on the market of plant reproductive material of listed 
genera or species complying with lower requirements that those adopted 
pursuant to this Regulation,  
(e) the organisation of temporary experiments,  
(f) the format of the national variety regi sters and the Union variety register, 
(g) the format for the application for the registration of varieties, 
(h) modalities concerning the submissi on of notifications concerning the 
registration of varieties,  
(i) the form of national lists concer ning forest reproductive material, 
(j) the format of the notificati on of inclusion of forest reproductive material in the 
national list, and 
(k) the format of master certificates for forest reproductive material. 
(80) Those implementing powers should be exer cised in accordance with 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. 
(81) This Regulation respects the fundamental rights and observe s the principles recognised 
in particular by the Charter of Fundamental  Rights of the European Union and notably 
respect for private and family life, the right  to property, the protec tion of personal data, EN 24   EN freedom to conduct business and the freedom  of art and science. This Regulation 
should be applied by the Member Stat es in accordance with those rights and 
principles. 
(82) Since the objective of this Regulation, namely to establish the rules concerning 
production and making available on the mark et of plant reproductive material to 
ensure quality of th e material and informed choi ces for the users, cannot be 
sufficiently achieved by the Member States an d can therefore, by reason of its effect, 
complexity, trans-border and international char acter, 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, 
HAVE ADOPTED THIS REGULATION: EN 25   EN PART I 
GENERAL PROVISIONS 
Article 1 
Scope  
This Regulation lays down rules on:  
(a) the production, with a view to making av ailable on the market, of plant reproductive 
material; and  
(b) the making available on the market  of plant reproductive material. 
Article 2 
Exclusions 
This Regulation shall not apply to plant reproductive material:  
(a) intended solely for tes ting or scientific purposes; 
(b) intended solely for breeding purposes;  (c) intended solely for, and maintained by, gene banks, organisations and networks of 
conservation of genetic resources, or pe rsons belonging to those organisations or 
networks;  
(d) exchanged in kind between persons other than professional operators.  
Article 3 
Definitions  
For the purposes of this Regulation, th e following definitions shall apply: 
(1) 'plants' means plants as defined in Article 2(1) of Regulation (EU) No …/… ( Office 
of Publications, please insert number of  Regulation on protective measures against 
pests of plants ) on protective measures against pests of plants; 
(2) 'plant reproductive material' means plan t(s) capable of, and intended for, producing 
entire plants; 
(3) 'mother plant' means an identified plant from which plant reproductive material is 
taken for reproduction of new plants; 
(4) 'generation' means a group of plants constitu ting a single step in the line of descent of 
plants; 
(5) ‘making available on the market’ means the holding for the purpos e of sale within 
the Union, including offering for sale or for any other form of transfer, and the sale, 
distribution, import into, and export out of , the Union and other forms of transfer, 
whether free of charge or not; 
(6) 'professional operator' means any natural or legal person carrying out, as a 
profession, at least on e of the following activ ities with regard to plant reproductive 
material:  
(a) producing ;  
(b) breeding;  EN 26   EN (c) maintaining;  
(d) providing services;  (e) preserving, includi ng storing; and  
(f) making available on the market.  
(7) 'competent authorities' means competent au thorities as defined in accordance with 
Article 2(5) of Regulation (EU) No …/…. [ Office of Publication, please insert 
number of Regulation on Official Controls ]; 
(8) 'genetically modified organism' means a ge netically modified orga nism as defined in 
Article 2(2) of Directive 2001/18/EC; 
(9) 'forest reproductive material' means plant reproductive material intended for forestry 
purposes; 
(10) 'lot' means a unit of pl ant reproductive material, identifiable by its homogeneity of 
composition and origin. 
Article 4  
Free circulation 
Plant reproductive material shal l be subject to no restrictio ns concerning its production and 
making available on the market, other than thos e laid down in this Regulation, in Directive 
94/62/EC, Regulation (EC) No 338/97, Directive 2001/18/ EC, Regulation (EC) No 
1829/2003, Regulation (EC) No 1830/2003, Regulation (EU) No …/… [ Office of Publication, 
please insert number of Regulation on pr otective measures against pests of plants ] and in 
Union legislation restricting the production or  making available on the market of invasive 
alien species. EN 27   EN PART II 
PROFESSIONAL OPERATORS 
Article  5 
Registers of professional operators 
Professional operators shall be registered in the registers referred to in Article 61 of 
Regulation (EC) No …/… ( Office of Publication, please insert number of Regulation on 
protective measures against pests of plants ) in accordance with the pr ovisions of Article 62 of 
that Regulation. 
Article 6 
General responsibilities of  professional operators 
Professional operators shall en sure that plant reproductive material produced and made 
available on the market under their control fu lfils the requirements of this Regulation. 
Article 7 
Specific responsibilities of professional operators produci ng plant reproductive material  
Professional operators producing plan t reproductive material shall: 
(a) be available personally, or designate a pers on, to liaise with the competent authorities 
for the purpose of facilitating the official controls; 
(b) identify and monitor the critical points of the production process, or of the making 
available on the market, which may influe nce the quality of the plant reproductive 
material; 
(c) keep records of the monitoring of the criti cal points referred to in point (b), which 
shall be available for examination when requested by the competent authorities; 
(d) ensure that lots remain separately identifiable; (e) keep updated information on the premises and other locations used for the production 
of plant reproductive material; 
(f) make sure that competent authorities  have access to the premises of production, 
including premises and fields of third cont racting parties, and to the records of the 
monitoring and all related documents; 
(g) take measures, where appropriate, for the maintenance of the identity of the plant 
reproductive material in accordance with th e applicable requirements of this 
Regulation; 
(h) make available to the competent authori ties, on request, any contracts with third 
parties. 
Article  8 
Traceability 
1. Professional operators shall ensure that plan t reproductive material is traceable at all 
stages of production and ma king available on the market. EN 28   EN 2. For the purpose of paragraph 1, professi onal operators shall keep information 
allowing them to identify the professional operators, which have supplied them with 
plant reproductive material, a nd the material concerned.  
On request, they shall make such informa tion available to the competent authorities. 
3. For the purpose of paragraph 1, professi onal operators shall keep information 
allowing them to identify the persons to whom they have supplied plant reproductive 
material and the material concerned, unless th at material has been supplied in retail. 
On request, they shall make such informa tion available to the competent authorities. 
4. In the case of plant reproduc tive material, other than forest reproductive material, 
professional operators shall k eep records of the plant reproductive material referred 
to in paragraphs 2 and 3 for three years af ter that material has been respectively 
supplied to or by them.  
In the case of forest reproductive material , the respective period shall be ten years.  EN 29   EN PART  III 
PLANT REPRODUCTIVE MATERIAL OTHER THAN 
FOREST REPRODUCTIVE MATERIAL 
TITLE I  
General Provisions 
Article 9 
Scope  
This Part shall apply to the pr oduction, with a view to making available on the market, and to 
the making available on the market of plan t reproductive material  other than forest 
reproductive material. 
Article 10 
Definitions 
For the purposes of this Part, the following definitions shall apply: 
(1) 'variety' means a plant grouping within a single botanical taxon of the lowest known 
rank, which fulfils all of the following requirements: 
(a) it is defined by the expression of the ch aracteristics that results from a given 
genotype or combination of genotypes; 
(b) it is distinguished from any other plan t grouping by the expre ssion of at least 
one of the characteristics refe rred to in point (a); and  
(c) it is considered as a unit with regard  to its suitability for being reproduced 
unchanged; 
(2) 'official description' means a variety description that has been produced by a 
competent authority, includes the specific ch aracteristics of the variety and makes the 
variety identifiable by examination of its distinctiveness, uniformity and stability;  
(3) 'officially recognised description' means a description of a va riety, which has been 
recognised by a competent authority, include s the specific characteristics of the 
variety, makes it identifiable and has been obtained by means other than examination 
of the variety's distinctiveness, uniformity and stability pursuant to the rules applicable at the time of re gistration of that variety in  accordance with Article 79;  
(4) 'clone' means an individual progeny, orig inally derived from another plant by 
vegetative reproduction, which remains ge netically identical  to the latter; 
(5) 'variety maintenance' means the actions to ensure that a variety remains consistent 
with its description; 
(6) 'pre-basic material' means plant reproductive  material which is at the first step of 
production and is intended for the production of other categories of plant reproductive material; 
(7) 'basic material' means plant reproductiv e material which has been produced from 
pre-basic material, and is intended fo r the production of certified material; EN 30   EN (8) 'certified material" means plant reproduc tive material which has been produced from 
pre-basic or basic material; 
(9) 'standard material' means plant reproductive  material other than pre-basic, basic or 
certified material; 
(10) 'category' means pre-basi c material, basic material, cert ified material or standard 
material.  
TITLE II 
Production and making availa ble on the market of plant 
reproductive material belonging to genera and species listed in 
Annex I 
CHAPTER I 
Introductive Provisions  
Article 11 
Scope 
1. This Title shall apply to the production a nd making available on the market of plant 
reproductive material belonging to genera and species which comply with one or 
more of the following criteria: 
(a) they represent a significant area of production; (b) they represent a signif icant value of production; 
(c) they are produced or made available on the market by a significant number of 
professional operators in the Union; 
(d) they contain substances which, for all or particular uses, must be subject to 
particular rules concerning the protection of human a nd animal health, and the 
environment. 
2. The genera and species referred to in  paragraph 1 are listed in Annex I. 
3. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, amending Annex I in  order to adapt it to the developments of technical 
knowledge, scientific knowledge and economic data. 
4. This Title shall also apply to rootstocks a nd other parts of plants  (hereinafter jointly 
referred to as "rootstocks"), which belong to genera and species not  listed in Annex I, 
if material of one of the genera or species  listed in Annex I, or their hybrids, is 
grafted on them. 
Article 12  
Categories of plant reproductive material 
1. Plant reproductive material may only be pr oduced and made available on the market, 
under one of the following categories:  
(a) pre-basic material, (b) basic material, EN 31   EN (c) certified material, 
(d) standard material. 
2. Plant reproductive material may not be pr oduced and made available on the market 
as standard material, if it belongs to genera or species for which the costs and 
certification activities necessary to produce and make available on the market plant 
reproductive material as pre-ba sic, basic and certified material are proportionate:  
(a) to the purpose of ensuring  food and feed security; and  
(b) to the higher level of identity, health and qualit y of the plant reproductive 
material which result from the fulfilment of the requirements for pre-basic, basic and certified material compared  to those for standard material. 
3. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, listing the genera or species w hose plant reproductive material may not 
be placed on the market as standard ma terial, as referred to in paragraph 2. 
4. By way of derogation to paragraph 2 and 3, plant reproductive mate rial shall only be 
produced and made available on the market as standard material if one or more of the 
following cases apply: 
(a) it belongs to a variety provided with an officially rec ognised description; 
(b) it is heterogeneous material in the meaning of Article 14(3); (c) it is niche market material in the meaning of Article 36(1). 
CHAPTER II 
Requirements for the production  and making available on the 
market  
SECTION 1 
LIST OF REQUIREMENTS  
Article 13 
Production and making available on the market  of pre-basic, basic, certified and standard 
material 
1. Plant reproductive material produced and ma de available on the market shall comply 
with: 
(a) the registration requireme nts set out in Section 2; 
(b) the production and quality requirements set out in Section 3 for the relevant 
category; 
(c) the handling requirement s set out in Section 4; 
(d) the identification, and, wh ere applicable, certificati on requirements set out in 
Section 5. 
2. Paragraph 1(b) shall not apply to production requireme nts of plant reproductive 
material referred to in Article 14(3) and Article 36. EN 32   EN Article 14 
Requirement to belong to registered varieties 
1. Plant reproductive material may be produ ced and made available on the market only 
if it belongs to a variety registered in a nati onal variety register re ferred to in Article 
51 or in the Union variety regist er referred to in Article 52.  
2. By way of derogation to paragraph 1 of th is Article, rootstocks may be produced and 
made available on the market without belongi ng to a variety registered in a national 
variety register or in th e Union variety register. 
3. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out that, by way of der ogation to paragraph 1 of this Article, 
plant reproductive material may be produ ced and made available on the market 
without belonging to a variety in the meaning of point (1) of Article 10 ('hereafter 
'heterogeneous material') and not fulfilling the requirements on distinctiveness, uniformity and stability as set out in arti cles 60, 61 and 62 and satisfactory value for 
cultivation and/or use or su stainable value for cultivati on and/or use as set out in 
articles 58 and 59. 
Those delegated acts may set out one or more of the following for heterogeneous 
material: 
(a) rules on labelling and packaging; (b) rules concerning description of the material, including the breeding methods 
and parental material used, descripti on of the production scheme for the plant 
reproductive material and availabi lity of standard samples; 
(c) rules relating to information and sa mples of production to be kept by the 
professional operators and the maintenance of the material; 
(d) establishment by the competent author ities of registers for heterogeneous 
material, modalities for registration and content of those registers; 
(e) establishment of fees, and cost ite ms for the calculation of those fees, 
concerning the registration of heterogeneous material referred to in point (d) in 
a manner ensuring that the fee does not cons titute a barrier to the registration of 
the heterogeneous material concerned. 
Those delegated acts shall be adopted by [Office of Publications, please insert date 
of application of this Regulation…] . 
They may be adopted per particular genera or 
species.  
Article 15 
Requirement to belong to registered clones  
Plant reproductive material belonging to a clone  may be produced and made available on the 
market only if that clone is registered in a natio nal variety register referr ed to in Article 51 or 
in the Union variety register  referred to in Article 52. EN 33   EN SECTION 2 
PRODUCTION AND QUALITY REQUIREMENTS  
Article 16 
Production and quality requirements  for plant reproductive material  
1. Plant reproductive material shall be produced in accordance with the production 
requirements set out in Part A of Annex II a nd shall be made available on the market 
only if it fulfils the quality requiremen ts set out in Part B of Annex II.  
2. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, supplementing the requirements  referred to in paragraph 1. Where 
appropriate, those delegated acts may specify those requirements set out in Part D of 
Annex II.  
3. Those delegated acts shall ta ke into account the relevant international technical and 
scientific standard recommendations:  
(a) the Seed Scheme Rules and Regulations of the Organisation for Economic Co-
operation and Development (hereinafter: 'OECD');  
(b) the seed potato standards of th e United Nations Economic Commission for 
Europe (hereinafter: 'UNECE');  
(c) the rules on sampling and testing of th e International Seed Testing Association 
(hereinafter 'ISTA'); and  
(d) the rules of the European and Med iterranean Plant Protection Organisation 
(EPPO). 
4. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, amending Part A and Part B of Annex II to adapt them to the technical 
and scientific developments. 
SECTION 3 
HANDLING REQUIREMENTS  
Article 17 
Lots 
1. Plant reproductive material shall be made available on the market in lots. Those lots 
shall be sufficiently homogene ous and identified as distinct  from other lots of plant 
reproductive material. 
2. During processing, packaging, storage, tr ansport or at delivery, lots of plant 
reproductive material of different origins may be merged into a new lot. In that case 
the professional operator shall keep records including data about the origin of the 
individual components of the new lot.  
3. During processing, packaging, storage, tr ansport or at delivery, lots of plant 
reproductive material may be split into two or  more lots. In that case the professional 
operator shall keep records concerning the origin of the new lots.  
4. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, establishing additional rules for part icular genera or species in relation to 
one or more of the following elements: EN 34   EN (a) maximum size of lots to ensure homoge neity of the plant reproductive material 
concerned;  
(b) composition of lots to ensure the maintenance of the identity of the plant 
reproductive material concerned; 
(c) identification of lots to ensure the tr aceability of the plant reproductive material 
concerned. 
Article 18 
Packages, containers and bundles, and rules on small packages and containers 
1. Plant reproductive material shall be ma de available on the market as individual 
plants, or in packages, containers or bundles. 
2. Packages and containers shall be closed in such a way that they cannot be opened 
without damaging the closure and, in the case of packaging, w ithout the packaging 
showing signs of tampering. 
3. Bundles shall be tied up in such a way th at the material formi ng parts of the bundles 
cannot be separated without damaging the tie or ties. 
4. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out rules for specific genera or species one or more of the 
following elements:  
(a) the closure, including se aling or resealing, of pack ages, containers or bundles 
to ensure the identity of the plant reproductive materi al concerned and to avoid 
uncontrolled mixtures of lots; 
(b) the establishment of a requirement th at plant reproductive material is to be 
made available on the market only in p ackages, containers or bundles in order 
to facilitate the traceability of the lots concerned. 
5. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting ou t specific rules for the produc tion and making available on the 
market of particular genera or species in small packages, containers or bundles. 
Those rules may concern one or mo re of the following elements: 
(a) maximum size and volume of the small packages, containers or bundles; (b) colour and content of labels, and met hods of labelling, of the small packages, 
containers or bundles; 
(c) examination of the small packages, containers or bundles and the contained 
plant reproductive material; 
(d) closure of the small packages. 
SECTION 4 
CERTIFICATION , IDENTIFICATION AND LABELLING REQUIREMENTS  
Article 19 
Certification and identification of pre-basic, basic or certifie d material, and identification 
of standard material 
1. Pre-basic, basic or certified material shall be certified and identified through an 
official label ('official label').  EN 35   EN 2. Official labels shall certify that pre-basi c, basic or certified material complies with 
the relevant production and quality require ments as referred to in Article 16. 
3. The certification referred to in paragraphs 1 and 2 shall be based on field inspections, 
sampling and testing carried out in accordance  with the rules referred to in Article 20 
(hereinafter: 'certification schemes') and with the provisions of Articles 22 to 26. 
4. Standard material shall be identified thr ough an operator's label ('operator's label'). 
5. Operators' labels shall attest that standard material complies with the relevant quality 
requirements as referred to in Article 16. 
Article 20 
Certification schemes  
1. The certification schemes for pre-basic, basic or certified material are set out in Part 
C of Annex II.  
2. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, supplementing the certificati on schemes. Where appropriate, those 
delegated acts may specify those schemes,  as set out in Part D of Annex II.  
3. Those delegated acts shall take into account the applicable intern ational technical and 
scientific standard recommendations such as:  
(a) the Seed Scheme Rules and Regulations of OECD;  (b) the seed potato standards of UNECE;  (c) the rules on sampling and testing of ISTA; and  (d) the rules of EPPO. 
3. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, amending Part C and Part D of Annex II to adapt th em to the technical 
and scientific developments. 
Article 21 
Content of the official label and operator's label  
1. The official label and the ope rator's label shall contain the information set out in Part 
A of Annex III. 
2. The official label and the ope rator’s label shall be written in one of the official Union 
languages. They shall be legi ble, indelible, prin ted on one side, not previously been 
used and easily visible. 
3. The official label shall have a distinct  colour per category of plant reproductive 
material. 
4. In case the issuance of a pl ant passport is required pur suant to Article 74(1) and 
Article 75(1) of Regulation (EU) No …/… [ Office of Publication, please insert 
number of Regulation on protective measures against pests of plants ], the official 
label shall include the plant passport as set out in Article  78(3) of that Regulation. 
5. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out requirements, furt her to the requirements referred to in 
paragraphs 1 and 2, for official labels a nd operators' labels. Those requirements shall 
concern one or more of the following elements: EN 36   EN (a) the colours of the label for specific categories and other groups of plant 
reproductive material;  
(b) indications concerning a label number; (c) indications of generations  of pre-basic, basic, cer tified and standard material; 
(d) the indication of variety types including intraspecific or interspecific hybrids;  
(e) the indication of subdivisions of cat egories satisfying different conditions; 
(f) in case of mixtures, the indication of the percentage by weight of the various 
components by species and, where appropriate, by variety;  
(g) indications concerning the in tended use of the material. 
6. This Article shall apply without prejudice  to Article 49 (4) of Regulation (EC) No 
1107/2009 concerning the label and the docu ments accompanying treated seeds in 
the meaning of that Regulation. 
7. The Commission shall, by means of implem enting acts, adopt the format(s) of the 
official label and operator's label. Those formats may be adopted per genera or species. Those implementing acts shall be  adopted in accordance with the 
examination procedure referre d to in Article 141(3).  
Article 22 
Responsibility to produce an d affix official labels 
The official labels shall be produced and affixed by: 
(a) the professional operator, under the offici al supervision of the competent authority; 
or 
(b) the competent authority, if requested so  by the professional operator, or if the 
professional operator concerned is not authorised pursuant to Article 23. 
Article 23 
Authorisation of professional operators to carry  out certification and produce official labels  
1. Professional operators may be authorised by the competent authority to carry out the 
certification and produce the official labels und er official supervision, as referred to 
in point (a) of Article 22 , only if they fulfil all of the following conditions: 
(a) they possess the necessary knowledge  to fulfil the production and quality 
requirements and comply with the certi fication schemes adopted pursuant to 
Articles 16(2) and 20(2), and, where appli cable, fulfil the requirements adopted 
pursuant to point (a) of para graph 3 of this Article;  
(b) they possess, or have access to, ade quate equipment and laboratories to apply 
correctly and efficiently the requirements referred to in Articles 16(2) and 20(2), in particular equipment a nd laboratories complying with the 
requirements adopted pursuant to poi nt (b) and (c) of paragraph 3;  
(c) they have identified, and ha ve the capability to monito r, the critical points of 
the production process which may influen ce the quality and identity of the 
plant reproductive material, and keep records of the results of that monitoring; 
(d) they are capable to ensure that lots remain identifiable as referred to in 
Article 7; EN 37   EN (e) they have in place systems and provisions to ensure the fulfilment of the 
traceability requirements set out in Article 8; 
(f) they use appropriately qualified inspect ion and laboratory sta ff, in particular 
inspection and laboratory staff, comp lying with the requirements adopted 
pursuant to point (c) of paragraph 3. 
2. The authorisation referred to in paragra ph 1 may be granted for particular or all 
genera or species.  
3. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, supplementing the provisions of pa ragraph 1, to ensure the ability of the 
professional operators to properly carry ou t a reliable certification of the plant 
reproductive material concerned. Those dele gated acts may concern one or more of 
the following elements:  
(a) qualification, training and activities of professional operators, and of other 
persons which may be entrusted, by th e professional operat ors, with field 
inspections, sampling and testing; 
(b) suitability of premises and availabilit y of particular equipment to be used by 
the professional operators concerned; 
(c) requirements for laboratories which may be entrusted with testing by the 
professional operators. 
Article 24 
Official supervision by the competent authorities 
1. For the purposes of the official supervis ion referred to in point (a) of Article 22, 
competent authorities shall, at least once per year, conduct audits to ensure that the 
professional operator fulfils the requi rements referred to in Article 23.  
2. For the purposes of the official supervis ion referred to in point (a) of Article 22, 
competent authorities shall furthermore car ry out official inspection, sampling and 
testing on a proportion of the crops in the fi elds and the lots of plant reproductive 
material, to confirm compliance of that  material with the production and quality 
requirements referred to in Article 16(2).  That proportion shall be determined on the 
basis of the potential risk of non- compliance with those requirements. 
3. In addition to the inspection, sampling and testing referred to in paragraph 2, the 
competent authorities may carry out further field inspections, sampling or testing, if 
requested so by the pr ofessional operator. 
4. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, supplementing the provisions of paragraphs 1, 2 and 3. Those delegated 
acts may concern one or more of the following elements:  
(a) the proportion of the crops  in the fields to be subject to inspections, sampling 
and testing, as referred to in paragraph 2, for particular genera or species;  
(b) monitoring activities to be carried  out by the competent authorities. EN 38   EN Article 25 
Official labels produced by the competent authorities  
Where the official labels are produced by the comp etent authorities, as referred to in point (b) 
of Article 22, the competent authorities sha ll carry out all necessary field inspections, 
sampling and testing in accordance with the certification schemes,  adopted pursuant to Article 
20(2), to confirm compliance wi th the production and quality requirements adopted pursuant 
to Article 16(2). 
Article 26 
Withdrawal or modificati on of the authorisation   
1. Where a competent authority finds, after granting the authorisation referred to in 
Article 23(1), that a professional operator doe s not fulfil the requirements referred to 
in that Article, it shall request the prof essional operator to ta ke corrective actions 
within a specified period of time. 
2. The competent authority shall without dela y withdraw, or modify as appropriate, the 
authorisation if the profe ssional operator does not appl y the corrective measures 
referred to in paragraph 1 of this Articl e within the specified period of time.  
Article 27 
Notification of the intended production and certification of pre-basic, basic and certified 
material  
Professional operators shall inform the competen t authorities in due time about their intention 
to produce pre-basic, basic and certified material plant reproduc tive material, and to carry out 
the certification referred to in Article 19(1). Th at notification shall state the plant species and 
categories concerned. 
Article 28 
Production of operator's label for standard material 
Operators' labels shall be produced and affi xed by the professional operator after verifying 
through its own inspections, sampling and tes ting, that the plant reproductive material 
complies with the production and quality re quirements as referred to in Article 16. 
Article 29 
Reference to lots  
1. The official label and the operator's label shall be produced with reference to a lot. 
They shall be affixed, where applicable, to  individual plants or  on the outside of 
packages, containers and bundles.  
2. If a lot is split into more lots, a new official label or operator's label shall be issued 
for each lot. If several lots are merged into a new lot, a new official label or 
operator's label shall be issued for that new lot. EN 39   EN CHAPTER III 
Tests  
Article 30 
Post certification tests for pre-bas ic, basic and certified material  
1. After the certification referred to in Article 19(1), the competent authorities may 
carry out tests on the plant reproductive material (hereinafter 'post certification tests') to confirm that it complies with the quality  requirements as referred to in Article 
16(2) and the certificatio n schemes adopted pursuant to Article 20(2).  
2. Competent authorities shall de sign and plan the post certif ication tests on the basis of 
a risk analysis concerning possible non-compliance of th e respective plant 
reproductive material with those requirements. 
3. Post certification tests shall be carried out through samples taken by the competent 
authority. They shall assess the identity and purity of the plant reproductive material concerned. 
4. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out rules for the post certification tests of plant reproductive 
material belonging to particular genera or species. Those rules shall take into account 
the development of scientific and tec hnical knowledge. They may concern the 
following: 
(a) the proportion of samples per genera and species and categories submitted to 
tests;  
(b) the testing procedure. 
Article 31 
Non-compliance of professional operators with  quality requirements and certification 
schemes  
1. Where the post certification tests show that pre-basic, basic or certified material has 
not been produced or made available on the market in compliance with the 
production and quality requirements referre d to in Article 16(2), and with the 
certification schemes referred to in Article  20(2), the competent authorities shall 
ensure that the professional operator concerned takes the necessary corrective 
actions. Those actions shall ensure that the material concerned either complies with those requirements or is withdrawn from the market. 
2. If it is repeatedly found, during the post ce rtification tests, that a professional 
operator produces or makes available on th e market plant reproductive material 
which does not comply with the quality requi rements referred to in Article 16(2), or 
with the certification schemes referred to  in Article 20, the pr ovisions of Article 
26(2) shall apply. EN 40   EN CHAPTER IV 
Mixtures  
Article 32 
Mixtures of genera and sp ecies listed in Annex I 
1. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, adopting rules concerning th e production and making available on the 
market of mixtures of plant reproductive ma terial belonging to different genera or 
species listed in Annex I, or different variet ies of those genera or  species. Those rules 
may derogate from the following provisions:  
(a) the production and quality requirements  adopted pursuant to Article 16(2);  
(b) the provisions of Ar ticle 17 concerning lots;  
(c) the provisions of Article 18 concerni ng packages, containers and bundles, and 
rules on small packages and containers; and 
(d) the provisions of Article 21, concerning the content and format of the official 
label and operator's label. 
2. The rules referred to in paragraph 1 shal l concern one or more of the following 
elements: 
(a) maximum size and volume of lots, packages, containers or bundles; (b) colour and content of labels; (c) denomination of the mixture and descri ption of the composition of the mixture; 
(d) closure of packages, containers or bundles; (e) requirements for the production a nd inspections of those mixtures; 
(f) requirements facilitating the traceability of the percentage by weight of the 
various components shown by species and, where appropriate, by variety. 
Article 33 
Preservation mixtures  
1. Competent authorities may authorise th e production and maki ng available on the 
market of a mixture of plant reproductive material belonging to  genera or species 
listed in Annex I, with plant reproductive ma terial belonging to genera or species not 
listed in Annex I, if that mixture fulfils both of the following conditions: 
(a) it contributes to the conservation of genetic resources and the preservation of 
the natural environment; 
(b) it is naturally associated with a pa rticular region (hereinafter: 'region of 
origin'). Hereinafter, such mixture is referred to as 'preservation mixture'. 
2. When a competent authority authorises the production and making available on the 
market of a preservation mixture, it shall identify the region of origin taking into 
account information from plant genetic re source authorities or organisations.  
3. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out, with regard to all or particular genera or species, the 
following: EN 41   EN (a) a procedure for the authorisa tion referred to in paragraph 1; 
(b) requirements for the authorisation refe rred to in paragraph 1, further to the 
requirements set out in that paragraph; 
(c) requirements for the packages and c ontainers of a preservation mixture; 
(d) labelling requirements for preservation mixtures; 
(e) rules on the identificat ion of region of origin; 
(f) the obligation for prof essional operators to re port on the production and 
making available on the market of preservation mixtures; 
(g) the obligation for Member States  to report to the Commission on the 
application of the provi sions of this Article. 
CHAPTER V 
Derogations  
SECTION 1 
DEROGATIONS FROM REGISTRATION REQUIREMENTS  
Article 34 
Plant reproductive material of varie ties whose registration is pending  
1. By way of derogation from Article 14( 1), competent authorities may authorise 
professional operators, for a specified pe riod of time, to make available on the 
market for tests and trials, on farms or other production premises, maximum 
quantities of plant reproductive material belo nging to a variety no t registered in a 
national variety register pursu ant to Article 79 or the Uni on variety register pursuant 
to Article 94(1). 
2. The authorisation referred to in para graph 1 may only be gr anted if the plant 
reproductive material belongs  to a variety for which an application has been 
submitted for registration in a national variety register pursuant to Article 66 or for 
registration in the Union variety register pursuant to Article 94. 
3. In order to obtain the authorisation refe rred to in paragraph 1, the professional 
operator shall submit to the competent authorities of the Member States, where the relevant tests and trials are to take place,  a request with the following information:  
(a) a description of the proposed tests and trials; (b) the objectives pursued by t hose proposed tests and trials; 
(c) the locations in which those tests and trials are to be carried out; (d) the provisional denomination of the va riety indicated in the application for 
registration; 
(e) the procedure for the maintenance of the variety; (f) information about the authority before which the application for the registration 
of the variety is pending, and the refe rence assigned to that application; 
(g) the duration of the au thorisation requested; 
(h) the quantities of the material to  be made available on the market. EN 42   EN 4. The Member States whose competent auth orities have granted the authorisation 
referred to in paragraph 1 shall inform  thereof the other Member States, the 
Commission and the European Agency fo r Plant Varieties (h ereinafter: "the 
Agency"). 
5. By 31 March of each year, the Agency shall report to the Commission and the 
Member States on the authorisations gr anted pursuant to paragraph 1 and the 
information submitted pursuant to paragraph 3 during the preceding year. 
6. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, supplementing paragraphs 1, 2 and 3 by setting out requirements 
concerning the following elements:  
(a) labelling of packages; and  (b) the maximum quantities which may be  made available on the market for 
specific genera or species pursuant to paragraph 1.  
Article 35 
Derogations from registration requirements in the case of temporary difficulties in supply  
1. By way of derogation from Article 14(1),  and in order to remove temporary 
difficulties in the general supply of plant re productive material that may occur in the 
Union, the Commission may, by means of implementing acts, authorise Member 
States to permit, for a maximum peri od of one year, the production and making 
available on the market of plant reproduc tive material belongi ng to a variety not 
included in a national variety register or  in the Union variety register. Those 
implementing acts may set out the maxi mum quantities which may be made 
available on the market per genera or species.  
2. The implementing acts referred to in para graph 1 shall be adopted in accordance with 
the examination procedure referred to in accordance with Article 141(3). 
3. The authorisations referred to in paragr aph 1 shall be grante d on the basis of a 
reasoned request submitted by the Member State concerned.  
4. Those authorisations shall only be granted if the derogation referred to in paragraph 1 
is necessary and proportionate to the object ive of removing the temporary difficulties 
in the general supply of the plan t reproductive mate rial concerned. 
5. The label of the plant reproductive material  made available on the market pursuant to 
paragraph 1 shall be brown. It shall state that the reproductive material in question 
belongs to a non-registered variety. 
Article 36 
Derogations from registration requirements in the case of niche market plant reproductive 
material  
1. Article 14(1) shall not apply to plant re productive material where all of the following 
conditions are fulfilled:  
(a) it is made available on the market in small quantities by persons other than 
professional operators, or by professi onal operators employing no more than 
ten persons and whose annual turnover or balance sheet to tal does not exceed 
EUR 2 million; 
(b) it is labelled with the indicat ion 'niche market material'. EN 43   EN That plant reproductive material  is hereinafter referred to as 'niche market material'. 
2. The persons who produce niche market materi al shall keep records of the quantities 
of the material produced and made available on the mark et, per genera, species or 
type of material. On request, they sha ll make those records available to the 
competent authorities. 
3. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out, with regard to the production and ma king available on the 
market of niche material belonging to particul ar genera or species, one or more of the 
following:  
(a) the maximum size of packages, containers or bundles; (b) requirements concerning traceability, lo ts and labelling of the niche market 
material concerned. 
(c) modalities of making available on the market. 
SECTION 2 
DEROGATION FROM PRODUCTION AND QUALITY REQUIREMENTS  
Article 37 
Reduced germination requirements, and other reduced quality requirements, in case of 
temporary difficulties in supply 
1. In order to remove temporary difficulties in the general supply of plant reproductive 
material that may occur in a Member Stat e, the competent authority of the Member 
State concerned may authorise the making av ailable on the market of seed with a 
reduced germination rate, provided that such rate is reduced by less than 5% compared to the germination rate re quired pursuant to Article 16(2).  
That authorisation shall be granted, on the basis of a reasoned request submitted by 
the professional operator concerned, for a sp ecific period of time which shall not 
exceed four months.  
The label of the seed referred to in pa ragraph 1 shall indicate the actual lower 
germination rate. 
2. In order to remove temporary difficulties in the general supply of plant reproductive 
material that may occur in a Member Stat e, the competent authority of the Member 
State concerned may authorise the maki ng available on the market of plant 
reproductive material with reduced quality  requirements, other than the reduced 
germination requirements as referred to in paragraph 1, compared to the quality requirements applicable pur suant to Article 16(2).  
That authorisation shall be granted, on the basis of a reasoned request submitted by 
the professional operator concerned, for a sp ecific period of time which shall not 
exceed four months.  
The label of the plant reproductive material made available on the market pursuant to 
this paragraph shall be brown. It shall state that the reproductive material in question 
complies with lower quality requirements than those referred to in Article 16(2). 
3. Member States shall notify the Commission and the other Member States of each 
authorisation granted pursua nt to paragraphs 1 and 2. EN 44   EN 4. The Commission may decide, by means of im plementing acts, that the authorisations 
referred to in paragraphs 1 or 2 are to be repealed or amended, in case those 
measures are not in compliance with the conditions of those paragraphs, or are 
deemed inappropriate or disproportiona te to achieve the objectives of those 
paragraphs. Those implementing acts sha ll be adopted in accordance with the 
examination procedure refe rred to in Article 141(3). 
SECTION 3 
DEROGATIONS FROM LABELLING , CERTIFICATION AND IDENTIFICATION 
REQUIREMENTS  
Article 38 
Plant reproductive material which is not finally certified 
1. Plant reproductive material, other than the seeds referred to in Article 39, which has 
been harvested in one Member  State, but has not yet be en finally certified as pre-
basic, basic or certif ied material pursuant to Article 19(1), may be made available on 
the market by reference to those categories if: 
(a) prior to the harvesting, a field inspec tion has been carried out by the competent 
authority and has confirmed compliance of  that material with the production 
and quality requirements referred to in Article 16(2); 
(b) the plant reproductive material is iden tified as not finally certified material 
pursuant to Article 19; and 
(c) the requirements set out in paragraphs 2 to 6 are fulfilled.  
2. Plant reproductive material referred to in  paragraph 1 may be made available on the 
market only once from one professional opera tor to another, without being further 
transferred to any other person.  
3. The professional operator shall inform in advance the competent authority concerned 
of its intention to make available on the market plant reproductive material referred 
to in paragraph 1. 
4. If the Member State, where the plant reproductive material has been harvested 
(hereinafter: 'Member State of production' ), and the Member State where the plant 
reproductive material is certif ied pursuant to Article 19( 1) (hereinafter: 'Member 
State of certification' ) are different, the competent auth orities of the Member States 
concerned shall exchange the relevant in formation concerning the making available 
on the market of that material. 
5. On request, the Member State of produc tion shall supply all relevant production 
information to the Member State of certifi cation. The Member St ate of certification 
shall supply information on the quantities certified to the Member State of production.  
6. The Commission shall be empowered to a dopt, in accordance  with Article 140, 
delegated acts setting out sp ecific rules for plant reproductiv e material referred to in 
paragraph 1, concerning the following elements:  
(a) packages, containers and bundles, and ru les on small packages and containers; 
(b) the labelling of that material. EN 45   EN 7. Plant reproductive material, other than the seeds referred to in Article 39, which has 
been harvested in a third country, but has not  yet been finally certified as pre-basic, 
basic or certified material pursuant to Ar ticle 19(1), may be made available on the 
market by reference to those categories if: 
(a) a decision on equivalence has been adopted pursuant to Article 44 concerning 
that third country,  
(b) the requirements set out in paragraphs 1(a) and (b), 2 and 3 and adopted 
pursuant to paragraph 6 are fulfilled,  
(c) the competent authorities of the Me mber State and thir d country concerned 
exchange the relevant information concerning the making available on the market of that material, and 
(d) on request, the competent authorities of  third country concerned supplies all 
relevant production information to the Member State of certification. 
8. For that purpose references made in t hose paragraphs to the Member States of 
production shall be construed as references made to the third country concerned, and 
references made in those paragraphs to the requirements set out pursuant to Article 16(2) shall be construed as references  made to equivalent requirements.  
Article 39 
Seeds not certified as complying wi th applicable germination requirements   
1. Competent authorities may authorise the ma king available on the market of seeds for 
a specific period of time, as pre-basic, basic or certified ma terial, without the 
germination requirements established pursuant to Article 16(2) having been yet confirmed, if this is considered necessary  to make seed rapidly available on the 
market.  
2. Seed referred to in paragraph 1 may be made available on the market only once, from 
one professional operator to a nother, without being furthe r transferred to any other 
person, on the basis of a provisional an alytical report concerning germination. 
3. The Commission shall be empowered, in  accordance with Article 140, to adopt 
delegated acts setting out the conditions unde r which seed of particular genera or 
species may be made available on the market as pre-basic, basic material or certified 
material pursuant to paragraphs 1 and 2. Those conditions may concern the 
following:  
(a) labelling requirements;  (b) the duration of period in which such  seed may be made available on the 
market; and  
(c) the content of the provisional analy tical reports concerning germination.  
SECTION 4 
DEROGATIONS FROM MISCELLANEOUS REQUIREMENTS  
Article 40 
More stringent quality requirements 
1. The Commission may authorise Member Stat es, by means of implementing acts, to 
adopt more stringent producti on and quality requirements th an those referred to in EN 46   EN Article 16(2), or more stringent certificati on rules than those referred to in Article 
20(1).  
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(3). 
2. In order to obtain the author isation referred to in paragraph 1, Member States shall 
submit to the Commission a request setting out: 
(a) the draft provisions contai ning the proposed requirements; 
(b) a justification on the necessity and pr oportionality of such requirements; and 
(c) whether the proposed requirements w ould be permanent or for a specified 
period. 
3. The authorisation referred to in paragra ph 1 shall be granted only if the following 
conditions are fulfilled: 
(a) the implementation of the draft provisi ons, as referred to in point (a) of 
paragraph 2, ensures improvement of the quality of the plant reproductive material concerned, protection of th e environment or sustainability of 
agricultural development; and 
(b) the draft provisions are necessary and proportionate to their objective. 
Article 41 
Emergency measures   
1. Where plant reproductive material is likely  to constitute a serious risk to human, 
animal and plant health and environmen t, and such risk cannot be contained 
satisfactorily by means of measures ta ken by the Member State concerned, the 
Commission shall take without delay, by means of implementing acts, any 
appropriate interim emergency measures. Those measures may include provisions 
restricting or prohibiting the making av ailable on the market of the plant 
reproductive material concerned, depending on the gravity of the situation.  
2. The measures referred to in paragra ph 1 may be taken on the Commission’s own 
initiative or at the request of a Member State. They shall be adopted in accordance 
with the examination procedure referred to in Article 141(3). 
3. On duly justified imperative grounds of urge ncy to address a serious risk to human 
health, the Commission shall adopt immedi ately applicable implementing acts in 
accordance with the procedure referred to in Article 141(4). 
4. Where a Member State officially inform s the Commission of the need to take 
emergency measures and the Commission has not acted in accordance with paragraph 1, that Member State may a dopt any appropriate interim emergency 
measures. Those measures may include provi sions restricting or prohibiting within 
the territory of that Member State the ma king available on the market of the plant 
reproductive material concerned, depending on the gravity of the situation. The 
Member State concerned shall immediately inform the other Member States and the 
Commission of the measures adopted, stating the grounds for its decision. 
5. The Commission may decide, by means of  implementing acts, that the national 
interim emergency measures referred to in paragraph 4 are to be repealed or 
amended. Those implementing acts shall be  adopted in acco rdance with the 
examination procedure referred to in Ar ticle 141(3). The Member State concerned EN 47   EN may maintain its national interim emergency measures until the date of application of 
the implementing acts referred to in this paragraph.  
6. This Article shall apply w ithout prejudice to any meas ures adopted pursuant to 
Article 23(2) of Directiv e 2001/18/EC or Article 34 of Regulation (EC) No 
1829/2003 which prohibits or restricts the cultivation of genetically modified 
organisms.  
Article 42 
Temporary experiments 
1. The Commission may, by means of implemen ting acts, decide the organisation of 
temporary experiments to identify improved alternatives to any measures set out in, 
or adopted under, this Part. Those impl ementing acts may provi de for derogations 
from the provisions of this Part. They shall be adopted in accordance with the examination procedure refe rred to in Article 141(3). 
2. The implementing acts referred to in paragr aph 1 shall specify th e genera or species 
concerned, the conditions of the experiment s per genera or species, the duration of 
the experiments, and the monitoring and reporting obligations of  the participating 
Member States. They shall take into account the evoluti on of techniques for 
reproduction, production and control of the plant reproductive material concerned.  
3. The duration of an experiment shall not exceed seven growing cycles of the plant 
reproductive material concerned, and shall in any case, not exceed seven years. 
CHAPTER VI 
Imports from and exports to third countries 
SECTION 1 
IMPORTS  
Article 43 
Imports on the basis of Union equivalence 
Plant reproductive material may be imported from third countries only if it is established, 
pursuant to Article 44, that it fulfils requirem ents equivalent to thos e applicable to plant 
reproductive material produced and made available on the market in the Union. 
Article 44 
Commission Decision on  equivalence  
1. The Commission may decide, by means of implementing acts, whether plant 
reproductive material of specific genera, species οr categories produced in a third 
country, or particular areas of a third country, fulfils re quirements equivalent with 
those applicable to plant reproductive material produced  and made available on the 
market in the Union, on the basis of:  
(a) a thorough examination of information and data provided by the third country 
concerned pursuant to Article 124( 1) of Regulation (EU) No …/… [ Office of 
Publications, please inse rt the number of the Regul ation on official controls ]; 
and EN 48   EN (b) the satisfactory outcome of a control performed in accordance with Article 
119(1) of Regulation (EU) No …/… [ Office of Publications, please insert the 
number of the Regulatio n on official controls ]. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(3). 
2. When adopting the decisions referred to  in paragraph 1, the Commission shall 
consider whether: 
(a) the controls on variety maintenance carri ed out in the third country afford the 
same assurances as those provided for in Article 86, if varietie s registered in a 
national variety register or in the Union variety register  are to be maintained in 
the third country concerned; and 
(b) the requirements in the third countr y concerning the prod uction and making 
available on the market of plant reproductive material: 
(i) afford the same assurances as the production requirements set out in Part 
A to Annex II, and the requirements adopted pursuant to Article 16(2); 
(ii) afford the same assurances as the quality requirements set out in Part B to 
Annex II, and the requirements a dopted pursuant to Article16(2); 
(iii) afford the same assurances as the certification schemes of Part C to 
Annex II, and the requirements a dopted pursuant to Article 20(1); 
(iv) afford the same assurance as the controls carried out according to 
Regulation (EU) No …/… [ Office of Publications, please insert number 
of Regulation on Official Controls ]. 
3. For the purpose of adopting the decisions referred to in paragraph 1, the Commission 
may apply the provisions of Article  71 of Regulation (EU) No …/… [ Office of 
Publication, please insert numbe r of Regulation on Official Controls ] concerning the 
approval of pre-export controls  carried out by third countries. 
 Article 45 
Information to be provided  in the case of imports  
1. Plant reproductive material imported from th ird countries shall be made available on 
the market with the following information: 
(a) an indication that the plant reproductive material concerned 'meets EU rules 
and standards'; 
(b) the species, variety, cate gory and lot number of the plant reproductive material 
concerned; 
(c) the date of official closure, in ca se of making available on the market in 
containers, packages or bundles; 
(d) the third country of production a nd the respective competent authority; 
(e) where applicable, the last third country where the plant reproductive material is 
imported from;  
(f) the declared net or gross weight of the imported plant reproductive material or 
declared number of imported lots  of plant reproductive material; 
(g) the person importing the pl ant reproductive material. EN 49   EN 2. The information referred to in paragraph 1 shall be provided:  
(a) in the case of pre-basic,  basic or certified material , on an official document or 
on an additional official label;  
(b) in the case of standard material, on the operator's label.  
SECTION 2 
EXPORTS  
Article 46 
Exports from the Union  
1. Where the export of plant reproductive mate rial to a third country is governed by an 
agreement with that third country, that e xport shall comply with that agreement.  
2. Where the export of plant reproductive mate rial to a third count ry is not governed by 
an agreement with that country, that export shall take place in accordance with the 
rules of the third country into which th at plant reproductive material is to be 
exported.  
3. Where the export of plant reproductive materi al to a third country  is neither governed 
by an agreement with a third country nor by the rules of the third country into which that plant reproductive material is to be exported, the requirements for production 
and making available on the market of pl ant reproductive material within the Union 
territory, as set out in Ar ticles 13 to 42, shall apply.  
TITLE III 
Production and making availa ble on the market of plant 
reproductive material not belonging to genera or species listed in 
Annex I 
Article 47 
Scope  
This Title shall apply to the production an d making available on the market of plant 
reproductive material belonging to genera and species other than the ones listed in Annex I. 
Article 48 
Basic requirements  
1. Plant reproductive material shall be made available on the market  in accordance with 
the following requirements: 
(a) it shall be visually free from any defects likely to impair its usefulness for the 
purposes it is intended; 
(b) it shall have good vigour and appropriate dimensions , as appropriate for the 
genera and species concerned, to ensure  its usefulness for the purposes it is 
intended; 
(c) in the case of seeds, it shall have satis factory germination, as appropriate for 
the genera and species concer ned, to allow an appropria te number of plants per 
area after sowing, and to ensure the maximum yield and quality of the 
production; EN 50   EN (d) if made available on the market with reference to a variety, it shall have 
sufficient varietal identity and purity, as  appropriate for the genera and species 
concerned, to ensure informed choices by its users; 
(e) it shall at least on visu al inspection, be substantia lly free from any pests 
impairing quality, or any signs or symptoms thereof, which reduce its usefulness. 
2. Compliance with the requirements of points (a ), (b), (c), (d) a nd (e) of paragraph 1 
shall be assessed in light of the applicable  international standa rd recommendations:  
(a) the Seed Scheme Rules and Regulations of OECD;  (b) the seed potato standards of UNECE;  (c) the rules on sampling and testing of the International seed testing association 
ISTA for the genera or species concerned;  
(d) and the rules of EPPO. 
3. Where no international standard recomm endations exist for genera or species 
concerned, compliance with the requirements of points (a), (b), (c), (d) and (e) of 
paragraph 1 shall be assessed in the light of, the relevant nati onal standards of the 
Member State, where the plan t reproductive material is fo r first time made available 
on the market 
4. Plant reproductive material sh all be made available on the market in lots. Where lots 
of plant reproductive material of different  origins are merged into a new lot during 
packaging, storage, transport or at deliv ery, the professional operator shall keep 
records including data about compositi on and the origin of the individual 
components of the new lots. 
If a lot is split into more lots, the professional operator shall keep records for each 
new lot and its origin. 
Article 49 
Labelling  
1. Plant reproductive material, when made  available on the market, shall be 
accompanied by a label, containing the information set out in Part B to Annex III. 
2. The label referred to in paragraph 1 sha ll be produced by the professional operator 
and shall be clear and indelible . It shall be affixed on the outside of the package, the 
container or the bundle of plan t reproductive material. It shall be printed in at least 
one of the official languages of the Union. 
3. Where reproductive material is made available on the market with a reference to 
genera or species rather than a variety, th e professional operator  shall indicate on the 
label referred to in paragraph 1 the species  or group of species in such a way as to 
avoid confusion with any varietal denomination. 
4. The colour and form of the label shall be substantially distinct from the colour and 
the form of the official labels referred to in Articles 19(1). 
5. This Article shall apply without prejudice  to Article 49 (4) of Regulation (EC) No 
1107/2009 concerning the label and documents accompanying treated seeds in the meaning of that Regulation. EN 51   EN Article 50 
Making available on the market  with reference to varieties 
1. Plant reproductive material shall be made available on the market with reference to a 
variety only in one or more of the following cases: 
(a) the variety is legally protected by a pl ant variety right in accordance with the 
provisions of Regulation (EC) No 2100/94 or in accordance with national 
provisions; 
(b) the variety is registered in a national variety register as referred to in Article 51 
or in the Union variety register as referred to in Article 52;  
(c) the variety has been entere d in any other public or priv ate list with an official 
or officially recognised de scription and a denomination. 
2. Plant reproductive material made available on the market pursuant to points (a) and 
(b) of paragraph 1 shall bear  the same variety denomination in all Member States. 
Where the variety is not protected by a plan t variety right or re gistered pursuant to 
Title IV, as referred to in points (a) and (b ) of paragraph 1, but has been entered in a 
public or private list with an official or  officially recognised description and a 
denomination as referred to in points (b) and (c) of that paragraph, the professional 
operator may request the advice of the Agen cy concerning the suitability of the 
denomination pursuant to the provisions of Article 64. Followi ng that request, the 
Agency shall submit to the applicant a recommendation on the suitability of the 
variety denomination, as requested by th e applicant, taking into account the 
requirements set out in Article 64.  
TITLE IV 
Registration of varieties in na tional and Union variety registers  
CHAPTER I 
Establishment of national an d Union variety registers 
Article 51 
Establishment of national variety registers  
1. Each Member State shall establish, publish and update a single na tional register of 
varieties and clones (hereinafter  'national variety register'). 
2. The Commission shall adopt, by means of implementing acts, the format of the 
national variety registers. Those implemen ting acts shall be adopted in accordance 
with the examination procedure referred to in Article 141(3).  
Article 52 
Establishment of a Union variety register 
1. The Agency shall establish, publish and upda te a single register of varieties and 
clones (hereinafter "Uni on variety register"). 
The Union variety register shall include the following: 
(a) varieties and clones dire ctly registered in the Un ion variety register in 
accordance with Chapter V; and  EN 52   EN (b) varieties and clones registered in nati onal variety registers in accordance with 
Chapter IV, as notified by the Member St ates to the Agency in accordance with 
Chapter VI. 
2. The Commission shall adopt, by means of implementing acts, the format of the 
Union variety register. Those implementing acts shall be adopted in accordance with 
the examination procedure referred to in Article 141(3). 
CHAPTER II 
Content of the national an d Union variety registers 
Article 53 
Data concerning varieties  
1. For varieties, the national and Union va riety registers shall include at least: 
(a) the name of the genus or speci es to which the variety belongs; 
(b) the denomination of the variety and, fo r varieties made available on the market 
before the entry into force of this Re gulation, where appli cable, its synonyms; 
(c) the name, and, where applicable, the reference number, of the applicant; 
(d) the date of the registration of the va riety and, where applicable, of the renewal 
of the registration; 
(e) the date of the end of validity of registration; (f) the official description of the variet y, or, where, applicable, the officially 
recognised description of th e variety with an indicati on of the region(s) where 
the variety has historically  been grown and to whic h it is naturally adapted 
("region(s) of origin"); 
(g) the name of the professional operato r responsible for the maintenance of a 
variety; 
(h) where applicable, the indication that th e variety contains a genetically modified 
organism; 
(i) where applicable, the indication that the variety is a component variety of 
another registered variety; 
(j) where applicable, the indication that plant reproductive material belonging to 
the variety is only produced and made av ailable on the market in rootstocks; 
(k) where applicable, a summary of the resu lts of the examinations for satisfactory 
value for cultivation and/or use as referre d to in Article 58, or sustainable value 
for cultivation and/or use as referred to in Article 59. 
2. Notwithstanding point (g) of paragraph 1, the names of the pr ofessional operators 
need not be indicated in the register when several profe ssional operators are 
responsible for the maintenance of the vari ety. In that case, the national variety 
registers and the Union variety register sh all indicate the competent authority holding 
the list of names of professional operators responsible for the maintenance of the variety. EN 53   EN Article 54 
Data concerning clones  
For clones, the national and Union variet y registers shall include at least: 
(a) the name of the genus or sp ecies to which the clone belongs; 
(b) the reference under which the variety, to wh ich the clone belongs, is registered in the 
national variety register or  Union variety register; 
(c) the denomination of the variety to which the clone belongs and, for varieties made 
available on the market before the entry into force of this Regulation, where applicable its synonyms; 
(d) the date of the registration of the clone and, where applicable, of  the renewal of the 
registration; 
(e) the end of validity of the registration; (f) where applicable, the indication that the variety to which the clone belongs has been 
registered with an officially recognised desc ription, including the re gion of origin of 
that variety; 
(g) where applicable, the indication that the cl one contains, or consis ts of, a genetically 
modified organism. 
Article 55 
Additional data to be included in the Union variety register 
In the case of a variety or clone, notified by a Member State to the Agency in accordance with 
Chapter VI, the Union variety register shall in clude, in addition to the data required pursuant 
to Articles 53 and 54: 
(a) the name of the Member States having established the releva nt national variety 
register(s); and 
(b) the reference under which the variety or clone has been registered in the national 
variety register(s). 
CHAPTER III 
Requirements for registration in the national and Union variety 
registers   
SECTION 1 
VARIETIES  
Article 56 
Registration requirements for varieties  
1. Varieties may be registered in a national va riety register pursuant to Chapter IV, or in 
the Union variety register pursuant to Chapter V, only if they fulfil the following requirements: 
(a) they bear a denomination deemed  suitable pursuant to Article 64; 
(b) they do not pose an unacceptable risk for human, animal and plant health, or 
the environment; EN 54   EN (c) in case of varieties belonging to a gene tically modified organism, that organism 
is authorised for cultivation pursuant  to Directive 2001/18/EC or Regulation 
(EC) 1829/2003. 
2. In order to be registered in a national variety register pursuant to Chapter IV, 
varieties shall fulfil, in addition to the requirements set out in paragraph 1, the following requirements: 
(a) they have an official description sh owing compliance with the requirements of 
distinctiveness, uniformity and stability set out in Articles 60, 61 and 62, or are 
provided with an officially recognise d description pursuant to Article 57; 
(b) in case they belong to genera or sp ecies with particular importance for the 
satisfactory development of agriculture in the Union, as referred to in paragraph 5, they have a satisfactory value for cultivation and/or use pursuant to Article 58; 
(c) in case they belong to genera or sp ecies with particular importance for the 
sustainable development of agriculture in  the Union, as referred to in paragraph 
6, they have a sustainable value for cult ivation and/or use pursuant to Article 
59. 
3. The requirements set out in paragraph 2(b)  and (c) shall not apply to the following 
varieties: 
(a) varieties provided only with an officially recognised description; 
(b) varieties used only as components for the creation or production of other 
varieties. 
4. In order to be registered in the Union vari ety register pursuant to  Chapter V, varieties 
shall fulfil, in addition to requirements set out in paragraph 1, the following requirements: 
(a) they have an official description sh owing compliance with the requirements of 
distinctiveness, uniformity  and stability set out in Articles 60, 61 and 62; 
(b) they do not belong to genera or speci es with particular importance for the 
satisfactory development of agriculture in the Union, as referred to in paragraph 5;   
(c) in case they belong to genera or sp ecies with particular importance for the 
sustainable development of agriculture in  the Union, as referred to in paragraph 
6, they have a sustainable value for cult ivation and/or use pursuant to Article 
59; 
(d) they are not used as mere component s for the creation or  production of other 
varieties. 
5. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, listing the genera or species with particular importance for the satisfactory development of agriculture in the Union. Those genera or species shall 
be listed in accordance with the crite ria set out in Part A of Annex IV. 
6. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, listing the genera or species with particular importance for the sustainable development of agriculture in the Union.  Those genera or species shall be 
listed in accordance with the criteri a set out in Part B of Annex IV. EN 55   EN Article 57 
Registration of varieties provided with  an officially recognised description 
1. A variety may be registered in a national va riety register on the ba sis of an officially 
recognised description if one of the following conditions are complied with:  
(a) in case the variety had been previous ly not registered in a national variety 
register or in the Union variety re gister and plant reproductive material 
belonging to that variety has been made  available on the market before the 
entry into force of this Regulation;  
(b) in case the variety had been previous ly registered in any national variety 
register or in the Union va riety register on the basis of a technical examination 
pursuant to Article 71, but has been delete d from those registers more than five 
years before the submission of the curre nt application and would not fulfil the 
requirements laid down in Articles 60, 61 and 62 and, where applicable, Article 
58(1) and Article 59(1). 
2. In order to be registered on the basis of an officially r ecognised descri ption, a variety 
shall comply, in addition to paragr aph 1, with the following conditions:  
(a) it is produced in the region(s) of origin; (b) it is not included in a na tional variety register or in  the Union variety register, 
as a variety with an official description; 
(c) it is not protected by a Un ion plant variety right as pr ovided for in Article 62 of 
Council Regulation (EC) No 2100/94, or by a national plant variety right, and 
it is not the subject of a pending application for such a right.  
3. After the registration of a variety in a na tional variety register pursuant to paragraph 
2(a), competent authorities may approve ad ditional region(s) of origin for that 
variety. 
4. The officially recognised de scription shall comply with  the following requirements: 
(a) it is based, where available, on information from plant genetic resources 
authorities or from organisations rec ognised for that purpose by the Member 
States; and 
(b) its accuracy is supported by the results of previous official inspections or 
unofficial examinations or knowledge ga ined from practical experience during 
cultivation, reproduction and use. 
Article 58 
Satisfactory value for cultivation and/or use  
1. For the purpose of paragraph 2(b) of Arti cle 56, varieties shall be  deemed to have a 
satisfactory value for cultivation and/or use if, compared to other varieties examined 
under similar agro-climatic conditions and similar production systems, their characteristics, taken as a whole, offer, at least as far as produc tion in any region is 
concerned, a clear improvement either for cu ltivation in general or for the specific 
uses which can be made of the crops or the products derived therefrom.  
2. Member States shall adopt  rules concerning the examin ations to determine the 
satisfactory value for cultivation and/or use of the varieties to be registered in their national variety register. Thos e rules shall concern the char acteristics of the varieties 
in one or more of the following areas: EN 56   EN (a) quality and agronomic charac teristics, incl uding yields; 
(b) suitability for cultivation in resi lience and low input production systems, 
including for organic agricultural production. 
Each Member State shall publish those ru les and notify them to the Agency, the 
Commission and the other Member States. 
Article 59 
Sustainable value for cultivation and/or use 
1. For the purpose of paragraph 2(c) and para graph 3(c) of Article 56, varieties shall be 
deemed to have a sustainable value for cult ivation and/or use if, compared to other 
varieties examined under similar agro-climatic conditions and similar production systems, their characteristics, ta ken as a whole, offer, at least as far as susceptibility 
to pests, input of resources, susceptibility to undesirable substances or adaptation to divergent agro-climatic conditions are c oncerned, a clear improvement either for 
cultivation in general or for the specific uses which can be made of the crops or the products derived there from. 
2. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out rules concerning the examinations to determine the sustainable value for cultivation and/or use of the varieties. Those rules shall concern 
the characteristics of the varieties in  one or more of the following areas: 
(a) resistance to pests;  (b) reduced need for input of specific resources;  (c) decreased content of un desirable substances; or  
(d) increased adaptation to divergent agro-climatic environment. Those rules shall take into account, where applicable, the available technical 
protocols. 
Article 60 
Distinctness  
1. For the purposes of the official descripti on, referred to in point (a) of Article 56(2) 
and (3), a variety shall be deemed to be di stinct, if it is clearly distinguishable, by 
reference to the expression of the characte ristics that results from a particular 
genotype or combination of genotypes, from  any other variety whose existence is 
commonly known on the date of the applica tion determined pursuant to Article 70.  
2. The existence of another variety, as referred to in paragraph 1, sh all be deemed to be 
commonly known, if on the date of the app lication determined pursuant to Article 70 
one or more of the following conditions are complied with: 
(a) that variety is included in a national variety register or in a Union variety 
register; 
(b) an application has been filed for regist ration of that variety in a national variety 
register pursuant to Article 66, or in the Union variety re gister pursuant to 
Article 95(1), or for the granting of a plant variety right in  respect of that 
variety in the Union;  EN 57   EN (c) an official description of that vari ety has been produced in the Union, and the 
technical examination has been conduc ted pursuant to th e provisions of 
Article 69, Article 71 and, wher e applicable, Article 73 . 
3. Where point (c) of paragraph 2 applies, the person(s) responsible for the technical 
examinations shall make available to the competent authorities and the Agency the 
official description of the variety examined by them. 
Article 61 
Uniformity 
For the purposes of the official description, referr ed to in point (a) of Article 56(2) and (3), a 
variety shall be deemed to be uniform if, subjec t to the variation that may be expected from 
the particular features of its reproduction and ty pe, it is sufficiently uniform in the expression 
of those characteristics which are included in th e examination for distinctness, as well as in 
the expression of any other characteristics  used for its official description. 
Article 62 
Stability 
For the purposes of the official description referr ed to in point (a) of Article 56(2) and (3), a 
variety shall be deemed to be stable if th e expression of those characteristics which are 
included in the examination for distinctness, as well as any other characteristics used for the 
variety description, remains unchanged after repeat ed reproduction or, in the case of cycles of 
reproduction, at the end of each such cycle. 
Article 63 
Granted plant variety rights 
If a variety has been granted a plant variety ri ght pursuant to Article 62 of Regulation (EC) 
No 2100/1994, or pursuant to the legi slation of a Member State, th at variety shall be deemed 
to be distinct, uniform and stable, for the purpose of the official description as referred to in 
point (a) of Article 56(2) and (3) and to have a suitable denomination for the purposes of point 
(a) of Article 56(1). 
Article 64 
Denomination of varieties  
1. For the purposes of point (a) of Article 56( 1), the denomination of a variety shall not 
be deemed suitable if: 
(a) its use in the territory of the Union is precluded by the prior right of a third 
party; 
(b) it may commonly cause its users diffi culties as regards recognition or 
reproduction; 
(c) it is identical to, or may be confus ed with, a variety denomination under which 
another variety of the same or of a cl osely related species is entered in a 
national variety register or in the Union variety regist er, or under which 
material of another variety has been made  available on the market in a Member 
State or in a Member of the Interna tional Union for the Protection of New 
Varieties of Plants, unless that other variety no longer remains in existence and 
its denomination has acquire d no special significance; EN 58   EN (d) it is identical to, or may be confus ed with, other designations which are 
commonly used for the making available on the market of goods or which have to be kept free pursuant to other Union legislation; 
(e) it is liable to give offence in one of the Member States or is contrary to public 
order; 
(f) it is liable to mislead or to cause conf usion concerning the characteristics, the 
value or the identity of the variet y, or the identity  of the breeder. 
2. Without prejudice to paragraph 1, if a variet y is already registered in other national 
variety registers, or in th e Union variety register, the denomination shall only be 
deemed suitable if it is identical to that appearing in t hose registrations.  
3. Paragraph 2 shall not apply if: 
(a) the denomination is likely to misl ead or cause confusion concerning the 
relevant variety in one or  more Member States; or 
(b) the rights of third parties impede the free use of that denomination in 
connection with the variety in question. 
4. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out specific rules co ncerning the suitability of variety 
denominations. Those rules may concern: 
(a) their relation to denominations of trade marks; (b) their relation to geographical indicat ions or designations of origin for 
agricultural products; 
(c) written consents of holders of prio r rights to remove impediments to the 
suitability of a denomination; 
(d) specific criteria to determine wh ether a denomination is misleading or 
confusing as referred to in paragraph 1(f); and 
(e) the use of a denomination in the form of a code. 
SECTION 2 
CLONES  
Article 65 
Registration requirements for clones  
1. A clone may be included in the national va riety register, or in the Union variety 
register, only if it complies w ith the following requirements: 
(a) it belongs to genera or species which have a particular value for particular 
market sectors and listed pursuant to paragraph 3; 
(b) it belongs to a variety re gistered in a national vari ety register pursuant to 
Chapter IV or in the Union variety register pursuant to Chapter V;  
(c) it has been subject to genetic selection; 
(d) it bears a suitable denomination. 
2. For the purpose of establishing whether a denomination is suitable as referred to in 
paragraph 1(d) of this Article, the provi sions of Article 64 shall apply with the EN 59   EN necessary modifications. References made in Article 64 to varieties shall be 
construed as references to clones. 
3. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, listing the genera or species, the clones of which have a particular value 
for particular market sectors. 
4. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out the following:  
(a) that clones belonging to particular genera  or species shall be subject to sanitary 
selection for the purpose of inclusion in a national variety re gister or in the 
Union variety register; and  
(b) the requirements for the sanitary selection referred to in point (a); 
CHAPTER IV 
National variety re gister procedures  
SECTION 1 
VARIETY REGISTRATION PROCEDURE  
Article 66 
Submission of applications  
1. Any person may submit to the competent aut hority an application for registration of a 
variety in the nationa l variety register.  
2. The application referred to in paragra ph 1 shall be submitted in writing. That 
submission may take place electronically. 
Article 67 
Content of applications  
1. The application for registrati on of a variety in a national va riety register shall contain 
the following items: 
(a) a request for registration; 
(b) the identification of the botanical taxon (genus or spec ies) to which the variety 
belongs; 
(c) the reference number of the applican t, where applicable, and its name and 
address, or, where appropriate, the name s and addresses of the joint applicants, 
and the credentials of any procedural representative; 
(d) a provisional denomination; (e) the name and address of the person responsible for the maintenance of the 
variety, and, where applicable, the reference number of that person; 
(f) a description of the main  characteristics of the va riety and, if available, a 
completed technical questionnaire; 
(g) a description of the proce dure of variety maintenance; 
(h) the geographic origin of the variety; EN 60   EN (i) information on whether the variety is registered in anot her national variety 
register, or the Union variety regist er, and on whether it is known to the 
applicant that an application for regi stration in one of those registers is 
pending; 
(j) where the variety contains or consis ts of a genetically modified organism, 
evidence that the genetically modified organism in question is authorised for 
cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 
1829/2003; 
(k) where the application is based on an officially recognised description of the 
variety, a file containing that desc ription and any document or publication 
supporting it; 
(l) in the case of an application concer ning varieties granted a plant variety right 
as referred to in Article 63, the proof that  the variety is protected by such right, 
with the corresponding o fficial description; 
(m) where applicable, a declaration that  the variety has satisfactory value for 
cultivation and/or a use as referred to in  Article 58(1) and/or  sustainable value 
for cultivation and/or use as referred to in Article 59(1). 
2. The application for registra tion of a variety in a nationa l variety register shall be 
accompanied by the submission of a sample of sufficient quality and quantity of the variety, as specified by the competent authority. 
3. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out additional items to be included in the application for particular genera or species, in relation w ith the particular features of the varieties 
belonging to those gene ra or species.  
Article 68 
Application format 
The Commission shall adopt, by means of implem enting acts, the format of the application 
referred to in Article 66. Those implementing ac ts shall be adopted in accordance with the 
examination procedure refe rred to in Article 141(3). 
Article 69 
Formal examination of application  
1. The competent authority shall register each application for registration in the national 
variety register it receives,  and shall carry out the fo rmal examination of that 
application. The formal examination of the application shall examine whether the 
application complies with: 
(a) the content requirements laid down in Article 67; and (b) the format adopted pursuant to Article 68. 
2. If the application does not comply with the requirements laid down in Article 67 or 
the format adopted pursuant to Article 68, the competent author ity shall give the 
applicant the possibility to make its a pplication compliant within a given time. EN 61   EN Article 70 
Date of application  
The date of application for registration shall be the date on which an application complying 
with the content requir ements laid down in Article 67 and the format adopted pursuant to 
Article 68 was submitted to the competent authority. 
Article 71 
Technical examination  
1. Where, as a result of the formal examinat ion, the application is found to comply with 
the content requirements referred to in Artic le 67 and the format adopted pursuant to 
Article 68, a technical examination of the va riety shall be carried out for the purpose 
of establishing an official description. 
2. The technical examination referred to in paragraph 1 shall verify: 
(a) the compliance with the requirements  for distinctiveness, uniformity and 
stability of the variety, as laid down in Articles 60, 61 and 62;  
(b) where applicable, that the variety has a satisfactory value for cultivation and/or 
use, according to Article 58(1) and a su stainable value for cultivation and/or 
use according to Article 59(1). 
3. The technical examination referred to in  paragraph 1 shall be carried out by the 
competent authorities in acco rdance with the requirements  referred to in Article 74. 
On request submitted by the applicant to the competent authority, the technical 
examination, or part of it, may be carried out by the applicant, in accordance with the 
provisions of Article 73 and the requ irements referred to in Article 74. 
4. In case an official description of the va riety, produced by the Agency or a competent 
authority, is already available, the competen t authority shall decide that the technical 
examination referred to in pa ragraph 1 is not necessary. 
5. By way of derogation from paragraph 4, th e competent authority may decide that the 
technical examination referred to in paragraph 1 is necessa ry in the case of a variety 
the registration of which is requested pursuant to point (b) Article 57(1). 
Article 72 
Audit of the competent authority 's premises and organisation 
1. The competent authority may carry out th e technical examination referred to in 
Article 71(1) only if its premises, which mu st be dedicated to this purpose, and its 
organisation have been audited by the Agency.  
That audit shall verify whether the premis es and the organisation of the competent 
authority are suitable for carrying out th e technical examination as regards:  
(a) compliance with the requirements for di stinctiveness, uniformity and stability 
referred to in Articles 60, 61 and 62; and  
(b) compliance with the requirements of a sustainable value for cultivation and/or 
use referred to in Article 59(1).  
2. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out the ru les concerning the audit refe rred to in paragraph 1.  EN 62   EN 3. On the basis of the audit referred to in paragraph 1, the Agency may recommend to 
the competent authority, if appropriate, ac tions to ensure the suitability of the 
premises and organisation of the competent au thorities. Further to the audit referred 
to in paragraph 1, the Agency may carry out additional audits and, where applicable, recommend to the competent authorities correc tive actions to ensure the suitability of 
their premises and organisation. 
Article 73 
Technical examination by the applicant  
1. The applicant may carry out the technical ex amination referred to in Article 71(1), or 
part of it, only if it has been authorised thereto by the competent authority. Technical 
examination by the applicant shall be carried out in particular premises, which are dedicated to this purpose. 
2. Prior to granting the authorisation to carry out the technical examination, the 
competent authority shall audit the premises  and the organisation of the applicant. 
That audit shall verify whether the pr emises and organisation are suitable for 
carrying out the technical ex amination as regards:  
(a) compliance with the requirements for di stinctiveness, uniformity and stability 
referred to in Articles 60, 61 and 62; and  
(b) compliance with the requirements of a satisfactory value for cultivation and/or 
use referred to in Article 58(1); 
(c) compliance with the requirements of a sustainable value for cultivation and/or 
use referred to in Article 59(1).   
3. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out the ru les concerning the audit re ferred to in paragraph 2. 
4. On the basis of the audit referred to in  paragraph 1, the comp etent authority may 
recommend to the applicant, if appropriate, actions to ensure the suitability of the 
applicant’s premises and organisation. 
5. Further to the authorisation and audit re ferred to in paragr aph 1, the competent 
authority may carry out addi tional audits and, where a pplicable, recommend to the 
applicant, within a specific period of time, corrective actions concerning the 
applicant’s premises and the organisation.  
In case the competent authority concludes that the applicant’s premises and organisation are 
not suitable, it may revoke or modify the au thorisation referred to in paragraph 1. 
Article 74 
Additional rules on technical examination 
1. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, supplementing the requirements on the technical examination laid down in Articles 71, 72 and 73. Those delegated acts may concern: 
(a) qualification, training and activities of staff of the competent authority, or of 
the applicant, for the purposes of th e technical examination referred to in 
Article 71(1);  
(b) the necessary equipment, includi ng laboratories for disease resistance 
characteristics, necessary to carry  out the technical examination; EN 63   EN (c) the establishment of a variety referen ce collection to assess  distinctness, and 
the storage management of su ch reference collection;  
(d) the establishment of quality management  systems, including record of activities 
and protocols or guidelines, to be us ed for the technical examination; 
(e) the conduct of growing trials and labor atory tests for particular genera or 
species. 
Those delegated acts shall take into account  the available techni cal and scientific 
protocols. 
2. Where no requirements have been adopt ed pursuant to paragraph 1, technical 
examinations shall be carried  out in accordance with nationa l protocols as regards the 
elements referred in points (a) to (e) of paragraph 1. 
Article 75 
Confidentiality  
1. Where, in the framework of the technical examination referred to in Article 71(1), an 
examination of the genealogical component s is necessary, the results of that 
examination and the description of the gene alogical components shall be treated as 
confidential, if the applicant so requests. 
2. In the case of varieties of  plant reproductive material intended exclusively for the 
production of agricultural raw materials for in dustrial purposes, and if so requested 
by the applicant, the results of the technical examination referred to in Article 71(1) 
and the intended uses of those varietie s shall be treated as confidential. 
Article 76 
Provisional examination report and provisional official description 
1. Following the technical examination referred to in Article 71(1), the competent 
authority shall produce a provisional examina tion report and, where it considers that 
the distinctiveness, uniformity and stability requirements, as referred to in 
Articles 60, 61 and 62, are complied with, a pr ovisional official description of the 
variety on the basis of that report. 
2. The provisional examination report may refer to findings of other examination 
reports, produced on the relevant variet y, by the competent authority concerned, 
other competent authorities or the Agency. 
3. The competent authority shall communicate the provisional examination report and 
the provisional official description of the variety to the applicant. 
4. Where the competent authority does not consid er the examination report to constitute 
a sufficient basis for a decision on the regi stration of the variet y, it shall provide a 
complementary examination of  its own motion, after consul ting the applicant, or on 
request of the applicant. Any complementar y examination carried out until a decision 
is taken pursuant to Article 79(1) shall be considered to be part of the technical examination referred to in Article 71(1). EN 64   EN Article 77 
Examination report and official description 
1. After having given the applicant an opportunity to comment on the provisional 
examination report and the provisional offi cial description, the competent authority 
shall establish a final examination re port and a final official description. 
2. Competent authorities shall, on reasoned request, make available the examination 
reports to third parties, subject to nationa l or Union provisions on data protection and 
applicable rules on confidentiality.  
Article 78 
Examination of the denomination  
1. After the formal examination of the applic ation referred to in Ar ticle 69, and prior to 
the registration of a variety in a national variety register  pursuant to Article 79, the 
competent authority shall consult the Ag ency on the variety denomination proposed 
by the applicant. 
2. The Agency shall submit to the comp etent authority a recommendation on the 
suitability of the variety denomination pr oposed by the applicant, in accordance with 
the requirements set out in Article 64. The competent authority shall inform the applicant on that recommendation.  
Article 79 
Decision on registration  
1. If, on the basis of the procedure set out in  Articles 66 to 78, it is concluded that the 
variety complies with the applicable requirements se t out in Article 56, the 
competent authority shall decide to regi ster the variety in the national variety 
register. 
2. The competent authority shall adopt a deci sion refusing registra tion in the national 
variety register if: 
(a) it establishes that the applicable requirements set out in Article 56, are not 
fulfilled; or 
(b) the applicant has failed to comply with  any obligations set out for it in Articles 
66 to 74. 
3. Decisions refusing the regist ration shall state the reasons  justifying the refusal.  
4. The competent authority shall communicate to the applicant a copy of the decision 
referred to in paragraphs 1 and 2.  
Article 80 
Already registered varieties and clones 
1. By way of derogation from Ar ticles 66 to 79, the competent authorities shall register 
in their national variety regist ers all varieties officially acc epted or registered, before 
the entry into force of this Regulation, in th e catalogues, lists or registers established 
by their Member States pursu ant to Article 3 of Direc tive 2002/53/EC, Article 3(2) 
of Directive 2002/55/EC, Article 7(4) of  Directive 2008/90/EC and Article 5 of 
Directive 68/193/EEC and all clones regist ered pursuant to Artic le 5 of Directive 
68/193/EEC, Article 7(4) of Directive 2008/90/EC, Chapter II of Directive EN 65   EN 2008/62/EC and Section I of Chapter II and Section I of Chapte r III of Directive 
2009/145/EC. 
2. Varieties accepted in accordance with Ar ticle 3 of Directive 2008/62/EC and Article 
3(1) of Directive 2009/145/EC shall be registered in the national variety registers as 
varieties provided with an o fficially recognised description. 
Article 81 
New denomination after registration  
Where, after the registration of a variety, it is established by the competent authority that at 
the time of the registration the denomination of the variety was not suitable within the 
meaning of Article 64, the appl icant shall submit an applicat ion for a new denomination. The 
competent authority shall decide on that appl ication upon consultation with the Agency. The 
competent authority may permit the previous  denomination to be used temporarily. 
SECTION 2 
REGISTRATION PERIOD AND VARIETY MAINTENANCE  
Article 82 
Validity period of the registration  
1. The validity period of the regi stration of a variety in a na tional variety register shall 
be 30 years. 
2. In the case of varieties consisting of, or containing, a genetically modified organism, 
the validity of the registration shall be limite d to the period for which that genetically 
modified organism is authorised for cultiv ation pursuant to Di rective 2001/18/EC or 
Regulation (EC) No 1829/2003. 
Article 83 
Duration of the renewal period 
1. The registration of a variety in a national variety register may be renewed for further 
periods of 30 years, in accordance with th e procedure and the conditions laid down in 
Article 84. 
2. In the case of a variety c onsisting of or containing a genetically modified organism, 
the renewal shall be limited to the peri od for which that genetically modified 
organism is authorised for cultivati on pursuant to Dir ective 2001/18/EC or 
Regulation (EC) No 1829/2003. 
Article 84 
Procedure and conditions for registration renewal  
1. Any person intending to renew the re gistration of a variety shall submit an 
application, no earlier than 12 months, an d no later than six months, before the 
expiration of the validity period as referred to in Article 82. 
2. The application shall be submitted in writing. That submission may take place 
electronically. It shall be accompanied by evidence showing that the conditions set 
out in paragraphs 3 and 4 are fulfilled. 
3. The renewal of the registration of a variety in a national variety register shall only be 
granted if the following conditions are met:  EN 66   EN (a) the variety continues complying with  the requirements of Article 56, and, 
where applicable of Article 57;  
(b) the competent authority determines that  a person is responsible for maintaining 
the variety in accordance with  the provisions of Article 86. 
4. The competent authority may renew the regi stration of a variety in a national variety 
register, without an application for renewa l being submitted pursuant to paragraphs 1 
and 2, where it considers that the renewal of that registration serves sustainable 
agricultural production and the preservati on of genetic divers ity, and that the 
conditions of paragraph 3 are fulfilled. 
Article 85 
Deletion from national variety registers  
1. The competent authority shall decide to delete a variety from the national variety 
register, in the following cases: 
(a) if the competent authority concludes, on the basis of any new evidence, that the 
requirements for registration, as set out in Article 56 are no longer fulfilled;  
(b) if a request to delete the variety fr om the national variety register has been 
submitted by the applicant; 
(c) if the applicant does not pay the annua l fee pursuant to point (d) of Article 
87(1)(e); 
(d) if the person responsible for the mainte nance of the variety, as referred to in 
Article 86(1), so requests, unless main tenance of the variety is assured by 
another person; 
(e) if the variety is no longer maintained  pursuant to requirements of Article 86; 
(f) if the variety is maintained in a third country, that third country has not 
provided assistance on the c ontrols of that maintenance pursuant to Article 
86(8); 
(g) if at the time of th e application, false or fr audulent data were supplied 
concerning the facts on the basis of which the registration was decided; 
(h) if, by the deadline to submit an applic ation for renewal referred to in Article 
84(1), the applicant has not submitted such an application and the validity period referred to in Article 82(1) has expired. 
2. On request by the applicant, the compet ent authority may allow a variety deleted 
from the national variety register in accordance to paragraph 1(b) to continue to be made available on the market until 30 June of the third year following the deletion 
from the register. 
That request shall be submitted no later than the date of the expiration of the 
registration period. 
3. After a variety is deleted from the national variety regi ster, the competent authority 
shall submit a sample of that variety, and its description, to a gene bank dedicated to 
the conservation of genetic resources. EN 67   EN Article 86 
Variety maintenance  
1. Varieties registered in a na tional variety register  shall be maintained by the applicant 
or by any other person acting in mutual agreement with the applicant. That other 
person shall be notified by the appl icant to the competent authority. 
2. Variety maintenance shall take place in accordance with accepted practices 
concerning, as appropriate, genera, sp ecies or types of varieties.  
3. The persons referred to in paragra ph 1 shall keep records concerning the 
maintenance of the variety. It shall at all times be possible for the competent authority to check the maintenance of the variety from those records. Those records 
shall also cover the production of pre-basi c, basic, certified and standard material, 
and the stages of production pr ior to pre-basic material. 
4. Varieties provided with an officially rec ognised description shall be maintained in 
their region(s) of origin. 
5. The competent authority shall carry out controls on the manner in which variety 
maintenance is carried out and may, to this  purpose, take samples of the varieties 
concerned. 
6. Where a competent authority finds th at the person responsible for variety 
maintenance does not comply with paragra phs 1 to 4, it shall give that person the 
opportunity to take corrective action. 
7. Where variety maintenance takes place in a Member State other than the Member 
State in whose national variety register the variety has been registered, the competent authorities of the two Member States concerne d shall assist each ot her in the controls 
on variety maintenance. 
8. Where variety maintenance takes place in a third country, the competent authorities 
of the Member State in whose national variet y register the variety has been registered 
concerned shall request the third country's authorities assistance in the controls on 
variety maintenance. 
SECTION 3 
REGISTRATION FEES  
Article 87 
Registration fees 
1. The competent authorities shall charge fees  to recover the nece ssary costs incurred 
for the following actions: 
(a) the formal examination of the a pplication referred to in Article 69; 
(b) the technical examination and the audits  referred to in Article 71 and Article 
73(1); 
(c) the examination of the variety de nomination referred to in Article 78; 
(d) the decision on registration referred to in Article 79, and any administrative 
appeal lodged pursuant to national rules against that decision;  
(e) the inclusion of the variety, or where applicable the clone, in the national 
variety register for each year of the duration of the registration;  EN 68   EN (f) controls on the maintenance as  referred to in Article 86(5). 
2. The actions referred to in paragraph 1 sh all only be carried out on demand submitted 
by the applicant to the competent authority, and after the respective fees have been 
paid. The demand shall be deemed not to have  been made, if the fees have not been 
paid within one month from the date on which the competent authority requested 
payment of the fees and indicated in that request the consequences of the failure to 
pay. 
3. The Commission shall be empowered to adopt  delegated acts, in accordance with the 
procedure referred to in Artic le 140, setting out the specific cost items to be covered 
pursuant to paragraph 1(a) to (f). 
Article 88 
Fees for varieties provided with an  officially recognised description  
1. In the case of varieties provided with an  officially recognised description, no fees 
shall be charged for the actions referred  to in point (e) of Article 87(1).  
2. In the case of varieties provided with an of ficially recognise d description, the 
competent authorities shall re duce the amount of the fee for the actions referred to in 
of points (a), (c), (d), and (f) of Article 87(1). That re duction shall take place in a 
manner to ensure that the fee does not consti tute a barrier to the registration of the 
variety concerned. 
Article 89 
Exemptions from the paym ent of registration fees  
1. Fees provided for in  Article 87 and 88 shall not direc tly or indirectly  be refunded, 
unless unduly collected.  
2. Applicants employing fewer than 10 pers ons and whose annual tu rnover or annual 
balance sheet total does not exceed EUR 2 million shall be exempted from the payment of the fees provided fo r in Article 87 and Article 88. 
3. The costs referred to in Ar ticles 87 and 88 shall not incl ude those incurred for the 
performance of official c ontrols on the applicants re ferred to in paragraph 2. 
SECTION 4 
REGISTRATION OF CLONES  
Article 90 
Applicable provisions  
1. For the registration of a clone in a nationa l variety register, Sec tions 1, 2 and 3 shall 
apply with the necessary modifications, excluding the following provisions: 
(a) the provisions on the content of a pplications as set out in Article 67; 
(b) the provisions referring to varietie s provided with officially recognised 
descriptions; 
(c) the provisions referring to varieties w ith sustainable or satisfactory value for 
cultivation and/or use. 
2. As regards the content of applications, Ar ticle 92 shall apply instead of Article 67. EN 69   EN Article 91 
References   
When applying Sections 1, 2 and 3 for the registra tion of a clone in a na tional variety register, 
references shall be construed as follows: 
(a) references to varieties shall be construed as references to clones; 
(b) references to Article 56 shall be co nstrued as references to Article 65;  
(c) references to the requirements set out in  Articles 60, 61 and 62 shall be construed as 
references to requirements set ou t in Article 65(1)(b) and (3); 
(d) references to Article 67, concerning the co ntent of applications, shall be construed as 
references to Article 92. 
Article 92  
Content of applications 
1. The application for registration of a clone in a national variety register shall contain 
the following items: 
(a) a request for registration; (b) the identification of the variety to which the clone belongs; 
(c) the name and address of the appli cant, or, where appropriate, the joint 
applicants, and the credentials of  any procedural representative; 
(d) a provisional denomination; (e) the name and address of the person responsible for the maintenance of the 
clone, and, where applicable, the re ference number of that person; 
(f) a description of the ma in characteristics of the clone and, if available, a 
completed technical questionnaire; 
(g) the geographic origin of the clone; (h) information on whether the clone is registered in anot her national variety 
register or Union variety register, and on whether it is known to the applicant 
that an application for regi stration of the clone in t hose registers is pending; 
(i) in the case of a clone containing or  consisting of a genetically modified 
organism, evidence that the genetically modified organism in question is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) 
No 1829/2003. 
2. The application for the registration of a cl one in a national variety register shall be 
accompanied by the submission of a sample of sufficient quality and quantity of the clone. EN 70   EN CHAPTER V 
Procedures concerning th e Union variety register 
SECTION 1 
SCOPE OF THE CHAPTER  
Article 93 
Relevant varieties and clones  
This Chapter shall apply to varieties and clones not registered in any na tional variety register 
pursuant to Article 79. 
SECTION 2 
REGISTRATION PROCEDURE  
Article 94 
Applicable provisions  
1. For the registration of a va riety or clone in the Union variety register, Chapter IV 
shall apply with the necessary modifi cations, excluding the following provisions: 
(a) the provisions on the examination of  denominations set out in Article 78; 
(b) the provisions on variety main tenance set out in Article 86; 
(c) the provisions referring to varieties provided with an officially recognised 
description; 
(d) the provisions on exemptions from the payment of registrati on fees, set out in 
Article 89(2) and (3). 
2. For the examination of denominations, fo r variety and clone maintenance and for 
exemptions from the payment of registrati on fees, Articles 95, 96 and 97 shall apply 
instead of the provisions referred to  in paragraph 1(a), (b) and (d). 
3. When applying Chapter IV for the registra tion of a variety or clone in the Union 
variety register, references sh all be construed as follows: 
(a) references to the competent authority shall be construed as references to the 
Agency;  
(b) references to national variety registers shall be construed as references to the 
Union variety register;  
(c) references to Article 78 shall be co nstrued as references to Article 95; 
(d) references to Article 86 shall be co nstrued as references to Article 96; 
(e) references to administrative appeal l odged pursuant to national rules against the 
respective decision shall be construed as re ferences to the appeal referred to in 
Article 98.  EN 71   EN Article 95 
Examination of the denomination 
1. After the formal examination of the applic ation referred to in Article 69, as applied 
pursuant to Article 94, and before a variety or  clone is registered in the Union variety 
register, the Agency shall examine the denom ination of the variety or clone proposed 
by the applicant. 
2. The Agency shall decide on the suitability  of the variety or clone denomination, in 
accordance with the requiremen ts set out in Article 64. 
Article 96 
Maintenance of varieties and clones 
1. Varieties and clones registered in the Uni on variety register shall be maintained by 
the applicant, or by any other person acting in mutual agreement with the applicant. 
The other person shall be notified to the Agency. 
2. The maintenance shall take place in  accordance with accepted practices, as 
appropriate per genera, species  or types of varieties. 
3. The person referred to in paragraph 1 sha ll keep records concerning the maintenance 
of the variety or the clone. It shall at all times be possible for the Agency to check the 
maintenance of the variety or the clone from  those records. Those records shall also 
cover the production of pre-basic, basic, certif ied and standard material, and stages of 
production prior to pre-basic material. 
4. The Agency shall check the way the main tenance is carried out and may, to this 
purpose, take samples of the varieties and the clones. 
5. The competent authorities of the Member State where the maintenance of the variety 
or the clone concerned takes place, shall a ssist the Agency as regards controls on 
maintenance. 
6. In case the Agency finds that the person responsible for the maintenance does not 
comply with the provisions of paragraphs  1, 2 and 3, it shall give that person the 
opportunity to take corrective action. 
Article 97 
Amount of fees 
1. The Commission shall be empowered to adopt delegated acts, in accordance with the 
procedure referred to in Artic le 140, setting out the amount of the fees referred to in 
Article 87(1) as applie d pursuant to Article 94. 
2. The level at which the fees are set pursuant  to paragraph 1 shall reflect the principle 
of sound financial management to allow th e Agency to maintain a balanced budget. EN 72   EN SECTION 3 
APPEALS  
Article 98 
Right of appeal  
An appeal shall lie from decisions of the Agen cy which have been taken pursuant to Section 
2. It shall be examined by the Board of Appeal of the Agency referred to in Article 46 of 
Regulation (EC) No 2100/1994. 
Article 99 
Provisions applicable to appeals   
1. Chapters V and VI of Part Four of Re gulation (EC) No 2100/ 1994 shall apply, with 
the necessary modifications, to a ppeals referred to in Article 98. 
2. Notwithstanding paragraph 1 of this Artic le, the following provisions of Chapters V 
and VI of Part Four of Regulation (E C) No 2100/1994 shall not apply to appeals 
referred to in Article 98: 
(a) Article 67 (1) and (3); (b) Article 74; (c) Article 80(5). 
Article100 
References  
For the purposes of Article 99(1), references cont ained in Chapters V and VI of Part Four of 
Regulation (EC) No 2100/1994 sha ll be construed as follows: 
(a) the reference made in Article 68 to Article 82 shall be omitted; (b) the reference made in Article 70(1) to "t he body of the Office which has prepared the 
decision" shall be construed as a reference made to the Agency; 
(c) the reference made in Article 76 to the "examination made pursuant to Articles 54 
and 55" shall be construed as a reference made to the technical examination of the application for registration carried out by the Agency pursuant to this Regulation; 
(d) the reference made in Article 78(3) a nd (4) to Article 90(2) shall be omitted; 
(e) the reference made in Article 79 to the "competent offices" shall be construed as a 
reference made to the competent authorities; 
(f) the reference made in Article 80(1) to the "applicant for a Community plant variety 
right or the holder" shall be  construed as a reference made to the applicant for 
registration; 
(g) the reference made in Article 80(3) to the "time limits specified in Article 52 (2), (4) 
and (5) shall be omitted; 
(h) the reference made in Article 81 to the "staff of the Examinat ion Offices" shall be 
omitted. EN 73   EN CHAPTER VI 
Notification of varieties to the Union variety register 
Article 101 
Notification procedure 
1. Each competent authority sh all notify within five working days the Agency of the 
application for registration of a variety, th e adoption of the decision referred to in 
Article 79, the new denomination after re gistration pursuant to Article 81, the 
renewal of the registration pursuant to Article 83, and the de letion of a variety 
pursuant to Article 85.  
2. Each competent authority shall notify the Agency of the person responsible for the 
maintenance of the variety pursuant to Artic le 86. That notifica tion shall take place 
within five working days from the date on which the competent authority has become 
aware of that person. 
3. The Commission shall establish, by mean s of implementing acts, procedures for 
submission of the notifications referred to in paragraph 1. Those implementing acts shall be adopted in accordance with th e examination procedure referred to in 
Article 141(3). 
CHAPTER VII 
Keeping and handling of information 
Article 102 
Documentation on the national variety regi sters and on the Union variety register 
1. The competent authority shall keep a file  on each variety regist ered in the national 
variety register, containing the official description, the examination report and any 
complementary examination report pursuant to  Article 76. Where applicable, the file 
shall only contain th e officially recognised descri ption of the va riety, and the 
documents supporting that description. 
2. The Agency shall keep a file on each variet y registered in the Un ion variety register, 
containing the official desc ription and the examination report issued pursuant to 
Article 94(1).  
Article 103 
Access to information of the national variety registers 
1. Each Member State shall inform the ot her Member States, the Agency and the 
Commission on the access to it s national variety register.  
2. By 31 March of each year, each competent authority shall notify to the other 
competent authorities and the Commission any amendments of the respective 
national variety registers which t ook place during the preceding year. 
3. Each competent authority sh all, on request, make avai lable to another competent 
authority, the Agency or the Commission: 
(a) where applicable, the examination re ports of varieties registered in the 
respective national variety register, as referred to in Article 77(1); EN 74   EN (b) where applicable, the results of techni cal examinations referred to in Article 
71(1); 
(c) the list of varieties for which an application for registration is pending; 
(d) any other information available in resp ect of registered or deleted varieties. 
4. The competent authority shall take appr opriate measures to make available the 
information contained in the files of th e national variety register to any person 
requesting access to this information. Th is provision shall not apply where the 
information must be treated as confidential pursuan t to Article 75. 
Article 104 
Access to information of the Union variety register 
1. The Agency shall notify the competen t authorities and the Commission of the 
information required to access the Union variety register. 
2. By 31 March of each year, the Agency shal l notify the competent authorities and the 
Commission of any amendments of the Un ion variety register made during the 
preceding year with regard to the varie ties registered pursuant to Article 94(1). 
3. The Agency shall, on request, and with rega rd to varieties registered in the Union 
variety register pursuant to Article 94(1), make available to a competent authority or 
the Commission: 
(a) the examination reports or the official description of the re gistered varieties; 
(b) the results of technical examinations; (c) the list of varieties for which a pplications for registration are pending; 
(d) any other information available in resp ect of registered or deleted varieties. 
4. The Agency shall take appropriate meas ures to make available the information 
contained in the files of the Union variety register to any person requesting access to 
that information. This provision shall not  apply where the information must be 
treated as confidential under Article 75. EN 75   EN PART IV 
PRODUCTION AND MAKING AVAILABLE ON THE 
MARKET OF FOREST REPRODUCTIVE MATERIAL 
TITLE I 
General provisions 
Article 105 
Scope 
This Part shall apply to the production a nd making available on the market, of forest 
reproductive material.  
Article 106 
Definitions  
1. For the purposes of this Part, the following definitions shall apply: 
(a) "basic forest material" means seed source, stand, seed orchard, parents of 
family, clone or clonal mixture; 
(b) "seed source" means trees within a delim ited area from which seed is collected; 
(c) "stand" means a delineated population of trees possessing sufficient uniformity 
in composition; 
(d) "seed orchard" means a plantation of selected clones or families, which is 
isolated or managed so as to avoid or reduce pollination from outside sources, and managed to produce frequent, abundant and easily harvested crops of seed; 
(e) "parents of family" means trees us ed to obtain progeny by controlled or open 
pollination of one identified parent used  as a female, with the pollen of one 
parent (full-sibling) or a number of identified or unidentified parents (half 
sibling); 
(f) "clone" means group of individuals (ra mets) derived originally from a single 
individual (ortet) by vegetative re production, including by cuttings, micro-
propagation, grafts, la yers or divisions; 
(g) "clonal mixture" means a mixture of  identified clones in known proportions; 
(h) ''Autochthonous stand" or "autochthonous  seed source" means a stand or seed 
source which:  
(i) has been continuously regenerate d by natural regeneration; or  
(ii) has been regenerated artificially from reproductiv e material collected in 
the same stand or seed source; or  
(iii) has been regenerated artificially from reproductiv e material collected in 
stands or seed sources, within  the close proximity, meeting the 
description in points (i) and (ii); EN 76   EN (i) "Indigenous stand" or 'i ndigenous seed source' means a stand or seed source 
raised artificially from seed, the origin of which is situated in the same region 
of provenance; 
(j) "origin" means:  
(i) for an autochthonous stand or seed  source – the place in which the trees 
are growing; 
(ii) for a non-autochthonous stand or seed source – the place from which the 
seed or plants were originally introduced; 
(k) "provenance" means the place in  which any stand is growing;  
(l) "region of provenance" means, for a sp ecies or sub-species,  the area or group 
of areas subject to suffici ently uniform ecological condi tions in which stands or 
seed sources showing similar phenotypic or genetic character s are found, and is 
delimited, where appropriate, by altitudinal boundaries; 
(m) "category" means any of the following groupings of derived forest reproductive 
material: source-identified, selected, qualified or tested reproductive material;  
(n) "source-identified": means derived from  basic forest material which may be 
either a seed source or st and located within a single region of provenance; 
(o) "selected": means derived from basic forest material co nsisting of a stand 
located within a single region of  provenance and which has been 
phenotypically selected at  the population level; 
(p) "qualified": means derived from basi c forest material consisting of seed 
orchards, parents of families, clones or clonal mixtures, the components of 
which have been phenotypically se lected at the individual level; 
(q) "tested": means derived from basic fore st material consisting of stands, seed 
orchards, parents of families, clones or clonal mixtures of superior quality; 
(r) "planting stock" means one of the following:  
(i) plants raised from seed units;  
(ii) plants raised from  parts of plants; or  
(iii) plants raised from natural regeneration(s); 
(s) "seed unit" means cones, infructesc ences, fruits and seeds intended for the 
production of planting stock; 
(t) "parts of plants" means stem cuttings, leaf cuttings and root cuttings, explants 
or embryos for micro-propagation, buds, layers, roots, scions, sets and any 
parts of a plant intended for th e production of planting stock; 
(u) "area of utilisation" means the area where the forest reproductive material is 
used for a specified purpose. EN 77   EN TITLE II 
Basic forest material 
Article 107 
Approval of basic forest material  
1. Basic forest material sha ll be approved by the competen t authority fo r the production 
of the relevant categories of forest reproduc tive material if it meets the requirements 
set out in Annexes V, VI, VII or VIII.  
2. Each unit of approved basic forest material (hereinafter: 'unit of approval') shall be 
identified by a unique reference to the register referred to  in Article 112(1). 
3. The approval shall be withdrawn, if the re quirements referred to in paragraph 1 are 
no longer met. 
4. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, supplementing the requirement s set out in point 3 of Annex VII 
concerning clones, and point 4 of A nnex VII concerning clonal mixtures, by 
determining the maximum number of years or the maximum number of ramets to 
which the approval of clones or clon al mixtures shall be restricted  
Article 108 
Provisional approval of basic fo rest material intended for th e production of tested material  
1. Basic forest material intended for the production of forest re productive material 
under the 'tested' category, whose compliance with the requirements referred to in 
Article 107(1) has not been establishe d, may provisionally be approved by the 
competent authorities for a maximum period of ten years, provi ded that it can be 
assumed that the basic forest material will, when tests have been completed, satisfy the requirements for approval. That assu mption shall be based on the provisional 
results of the genetic evaluation or comp arative tests referred to in Annex VIII. 
2. The provisional approval referred to in paragraph 1 may cover all or part of the 
territory of the Member Stated concerned.  
Article 109 
Post approval inspections 
After the approval referred to in Articles 107 and 108, basic forest material intended for the 
production of forest reproductive  material under the selected, qualified and test ed categories 
shall be re-inspected by the competent author ity at regular intervals to confirm compliance 
with those Articles.  
Article 110 
Demarcation of regions of provenance  
1. The Member States shall demarcate the regions of provenance of basic forest 
material consisting of stands or seed sour ces and intended for the production of forest 
reproductive material under the ‘source-id entified’ and ‘selected’ categories. 
2. Member States shall draw up and publish maps showing the demarcations of the 
regions of provenance. Those maps sha ll be communicated to the Commission and 
other Member States. EN 78   EN Article 111 
Notification of the intention to colle ct approved basic forest material 
The professional operators shall inform the co mpetent authorities in due time about their 
intention to collect material from  approved basic forest material. 
Article 112 
National register and national list of approved basic forest material  
1. Member States shall establis h a national register of basic forest ma terial approved on 
their territory pursuant to Article 107 and Article 108. Th at register shall contain 
information concerning the unit of approva l together with its unique register 
reference. 
2. Each Member State shall establish, publish and update a summary of the national 
register in the form of a national list.  
3. The national list referred to in paragraph 2 shall be drawn up in a common form. It 
shall enumerate each unit of approval. However, for basic forest material intended for the categories 'source-iden tified- and 'selected', a fu rther summarisation based on 
regions of provenance shall be permitted. 
4. The national list referred to in paragr aph 2 shall contain the following details: 
(a) botanical name; (b) category for the production of which th e basic forest material is intended; 
(c) purpose of the forest reproductive mate rial which will derive from the basic 
forest material; 
(d) type of basic forest material (see d source, stand, seed orchard, parents of 
family, clone or clonal mixture); 
(e) register reference to the unit of approval or, where appropriate, summary 
thereof or identity code of  the region of provenance; 
(f) location: a short name, if appropria te, and any of the following sets of 
particulars: 
(i) for basic forest material intended for production of the ‘source-identified’ 
category, region of provenance and ge ographical position defined by the 
latitudinal and longitudinal range; 
(ii) for basic forest material inte nded for production of  the ‘selected’ 
category, the region of provenance a nd the geographical position defined 
by latitude and longitude or the latitudinal and lo ngitudinal range; 
(iii) for basic forest material inte nded for production of the ‘qualified’ 
category, the exact geographical position(s) where the basic material is maintained; 
(iv) for basic forest material intende d for production of th e ‘tested’ category, 
the exact geographical position(s) where the basic material is maintained; 
(g) altitude or altitudinal range; (h) area: the size of a seed source( s), stand(s) or seed orchard(s); EN 79   EN (i) origin: whether the basic mate rial is autochthonous/indigenous, non 
autochthonous/non-indigenous or if the origin is unknown. For non-autochthonous/non-indigenous basic materi al, the origin shall be stated if 
known; 
(j) in the case of basic forest material intended for the ‘tested’ category, whether it 
is genetically modified. 
5. The Commission shall, by means of implementing acts, adopt the common form in 
which national lists shall be establishe d, as referred to in paragraph 3. Those 
implementing acts shall be adopted in acc ordance with the ex amination procedure 
referred to in Article 141(3). 
Article 113 
Union List of Approved Basic Forest Material  
1. Member States shall notify to the Agency, the Commission and the other Member 
States the national list referred to in Article 112(2) and any of its updates within five 
working days. 
2. On the basis of the national lists notified by each Member State, the Agency shall 
establish, publish and update a register entitled ‘Union Li st of Approved Basic Forest 
Material for the Production of Forest Reproductive Material'. 
The Agency shall include in that register  all elements of the Community List of 
Approved Basic Material for the Productio n of Forest Reproductive Material 
published pursuant to Article 11(1) of Directive 1999/105/EC. 
3. That Union list shall reflect the details contained in the national lists referred to in 
Article 112 and indicate the area of u tilisation, and any authorisations granted 
pursuant to Article 128.  
4. The Commission shall adopt, by means of implementing acts, the format of the 
notification referred to in paragraph 1 and of  the register referre d to in paragraph 2. 
Those implementing acts shall be adopted  in accordance with the examination 
procedure referred to in Article 141(3).  
TITLE III 
Making available on the market of material derived from basic 
forest material 
Article 114 
Scope 
This title shall apply to the making available on  the market of forest reproductive material 
derived from basic forest material. 
CHAPTER I 
List of requirements  
Article 115 
Requirements for making available on th e market of forest reproductive material  
Forest reproductive material may only be made  available on the market if it complies with: EN 80   EN (a) the registration requireme nts set out in Chapter II; 
(b) the quality requirements set out in Chapter III for the relevant category; 
(c) the handling requirement s set out in Chapter IV; 
(d) the certification and identification requirements set out in Chapter V. 
CHAPTER II 
Registration requirements 
Article 116 
Forest reproductive material de rived from basic forest materi al registered in a national 
register  
Forest reproductive material may be made ava ilable on the market only if it is derived from 
approved basic forest material re gistered in a national register pursuant to Article 112(1) and 
approved for the relevant cate gory pursuant to Title II. 
CHAPTER III 
Quality requirements 
Article 117 
Quality requirements 
1. Forest reproductive material shall be made available on the market under the 
categories ‘source-identified’, ‘selec ted’, ‘qualified’ or ‘tested’. 
2. Forest reproductive material  belonging to the species and artificial hybrids listed in 
Annex IX may not be made available on the market under the source identified 
category if it is has been obtained from vegetative reproduction of other forest 
reproductive material. 
3. Forest reproductive material belonging to  the artificial hybrids listed in Annex IX 
shall only be made availabl e under the categories ‘selected’ , ‘qualified’ or ‘tested’.  
4. Forest reproductive material  belonging to the species and artificial hybrids listed in 
Annex IX may only be made available on th e market under ‘selected’ category if it 
has been mass propagated from seeds 
5. Notwithstanding paragraphs 1 and 2, forest  reproductive material belonging to the 
species and artificial hybrids li sted in Annex IX, which cons ists wholly or partly of 
genetically modified organisms may only be  made available on the market under the 
‘tested’ category. 
6. The types of basic forest material whic h shall be used for the production of the 
various categories of forest reproductive material belonging to the species and 
artificial hybrids listed in A nnex IX are set out in Annex X. 
Article 118 
Additional requirements fo r certain forms of forest reproductive material  
Forest reproductive material belonging to the sp ecies and artificial hybr ids listed in Annex IX 
and referred to in Annex XI may only be made available on the market if it meets the quality 
requirements set out in Annex XI , in addition to those applic able pursuant to Article 117. EN 81   EN Article 119 
Additional requirements for certain parts of plants and planting stock  
The Commission shall be empowered to adopt de legated acts, in accordance with Article 140, 
setting out quality requirements for making ava ilable on the market specific parts of plants 
and planting stock of species and artificial hybrids listed in Annex IX, supplementing the 
requirements referred to in Articles 117 and 118 . Those requirements shall take into account 
the development of scientif ic and technical knowledge. 
CHAPTER IV 
Handling requirements  
Article 120 
Lots 
1. Forest reproductive material shall, duri ng all stages of produc tion, be kept in 
separated lots by reference to individual units of approval from which it derives.  
2. Forest reproductive material shall be made available on the market in lots.  
Article 121 
Packaging of seed units  
Seed units shall be made available on the mark et only in sealed pack ages. The sealing device 
shall be such that it will become uns erviceable when the package is opened. 
CHAPTER V  
Certification and identif ication requirements  
Article 122 
Master certificate  
1. After harvesting, a master certif icate showing the reference of  the register referred to 
in point (e) of Article 112(4)  shall be issued by the competent authority for all forest 
reproductive material derived from approved forest basic material.  
2. The master certificate shall contain the rele vant information set out, as applicable, in 
Part A, Part B and Pa rt C of Annex XII. 
3. For subsequent vegetative reproduction in  accordance with Article 117(2), a new 
master certificate shall be issued. 
4. Where mixing takes place in accordance with  Article 126(1), (2), (3) or (5), a new 
master certificate, or other document, identi fying the previous master certificates of 
the material composing the mixture shall be issued. 
5. The Commission shall determine, by means of implementing acts,  the model of the 
format of the master certificate as refe rred to in paragraph 1. Those implementing 
acts shall be adopted in accordance with the examination procedure referred to in 
Article 141(3). EN 82   EN Article 123 
Identification of lots   
1. Each lot shall remain clearly identifiable through the entire pr ocess from collection 
to delivery to the end user. 
2. Each lot of forest reproductive materi al shall be identif ied by the following 
information: 
(a) the master certificate code and number; (b) the botanical name; (c) the category of forest  reproductive material;  
(d) the purpose; (e) the type of basic forest material fr om which the forest reproductive material 
derives (seed source, stand, seed orchar d, parents or family, clone or clonal 
mixture);  
(f) the register reference of the basic forest  material or identity code of the region 
of provenance of the basic forest material; 
(g) whether the basic forest material, fro m which the forest reproductive material 
derives, is autochthonous or indige nous, non-autochthonous or non-indigenous, 
or whether its origin is unknown; 
(h) in the case of seed units, the year of ripening; (i) the age of planting stock, of seedlings or of cuttings;  (j) the type of planting stock (whether u ndercuts, transplants or containerised); 
(k) where applicable, the fact th at it is genetically modified; 
(l) where applicable, the fact that it  has been vegetatively reproduced. 
Article 124 
Labelling  
1. Each lot shall be accompanied by a labe l produced by the professional operator 
(hereinafter 'operator's label'). The operato r's label shall contain, in addition to the 
information required under Article 123, the following information: 
(a) the master certificate nu mber(s) issued under Article 122(1) or the reference to 
the other document available according to Article 122(4); 
(b) the reference number, where applicable , and the name of pr ofessional operator; 
(c) the quantity supplied; (d) in the case of forest reproductive materi al of the ‘tested’ category derived from 
basic forest material whic h is provisionally approved under Article 108(1), the 
words ‘provisionally approved’. 
2. In the case of seeds, the operator's label shall also include the following information:  
(a) the percentage by weight of pure seed, other seed and inert matter;  
(b) the germination rate of the pure seed, or, where germination rate is impossible 
or impractical to assess, the viability percentage assessed by reference to a 
specified method; EN 83   EN (c) the weight of 1 000 pure seeds; 
(d) the number of germinable seeds per k ilogram of product made available on the 
market as seed, or, where the number of  germinable seeds is impossible or 
impractical to assess, the number  of viable seeds per kilogram. 
3. The colour of the operator's label shall be yellow in the case of ‘source-identified’ 
reproductive material, green in the case of ‘selected’ reproductiv e material, pink in 
the case of ‘qualified’ reproductive material  and blue in the case of ‘tested’ 
reproductive material. 
4. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 140, setting out the conditions under which the operator's label shall be 
supplemented by another document produced by the professional operator. Those 
delegated acts shall determine the informati on items to be included in that document.  
Article 125 
Labelling of forest reproductive materi al belonging to Populus spp. species  
In the case of Populus spp., parts of plants shall only be ma de available on the market if the 
Union classification number according to point 2(b) of Annex XI, Pa rt C is given on the 
operator's label. 
Article 126 
Mixtures of forest reproductive material  
1. Mixtures of forest reproduc tive material shall be produced  and made available on the 
market in accordance with the provisions of this Article. 
2. Mixing of forest reproductive material de rived from two or more units of approval 
within the ‘source-identified’ category or within the ‘selected’ category may take 
place if the units of appr oval are located in the same region of provenance. 
3. When forest reproductive material derived from different seed s ources and stands is 
mixed pursuant to paragraph 2 within the ‘source-identified’ category, the new 
combined lot shall be certified as ‘reproducti ve material derived from a seed source’. 
4. When forest reproductive material de rived from non-autochthonous or non-
indigenous basic forest mate rial is mixed pursuant to paragraph 2 with forest 
reproductive material derived from basic fo rest material of unknown origin, the new 
combined lot shall be certifie d as being ‘of unknown origin’. 
5. When mixing takes place in accordance with paragraph 4, the identity code of the 
region of provenance may not be substituted for the register reference as provided for in Article 123(f). 
6. Mixing of forest reproductive material de rived from a single unit of approval from 
different years of ripening may take place provided that the actual years of ripening 
and proportion of material from each year are recorded by the professional operator. 
Article 127 
Amendments to Annexes V to XII  
The Commission shall be empowered to adopt de legated acts, in accordance with Article 140, 
amending Annexes V to XII. Those amendments shall take into account the development of 
scientific or technical kn owledge and economic data. EN 84   EN TITLE IV 
Derogations 
Article 128 
More stringent requirements and prohibitions 
1. The Commission may, by means of implementing acts, authorise Member States: 
(a) to adopt more stringent quality requir ements than those referred to in Article 
117 and 118; and 
(b) to prohibit the making available on th e market with a view to seeding or 
planting in all or part of its territory of  specified forest reproductive material.  
The prohibition referred to in  point(b) may be restricted  to making available on the 
market to the end users only. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to in Article 141(3).  
2. In order to obtain the authorisation referre d to in paragraph 1(a) and (b), Member 
States shall submit to the Co mmission a request setting out: 
(a) draft provisions concerning the pr oposed requirements or prohibitions; 
(b) a justification on the necessity and proportionality of such requirements or 
prohibitions;  
(c) whether the proposed requirements or pr ohibitions would be permanent or for a 
specified period. 
3. The authorisation referred to in para graph 1 shall be granted if the following 
conditions are fulfilled: 
(a) the implementation of the restrictions or  prohibitions referred to in paragraph 1, 
ensures improvement of the quality of  the forest reproductive material 
concerned, protection of the environment or conservation of genetic resources; 
and 
(b) the restrictions or prohibitions referred to in paragraph 1 are necessary and 
proportionate to their objective. 
4. The authorisation referred to in paragr aph 1 shall be granted on the basis of: 
(a) evidence relating to the region of provena nce or the origin of the material, and 
documentation showing the differences  in the respective climatic and 
ecological data; or 
(b) known results of trials, scientific resear ch, or the results obt ained from forestry 
practice concerning survival and deve lopment of planting stock, including 
growth, in relation to morphological and physiological characteristics. 
Article 129 
Temporary difficulties in supply  
1. In order to remove temporary difficulties in the general supply of forest reproductive 
material that may occur in a Member Stat e, the competent authority of the Member 
State concerned may authorise the making available on the market of forest EN 85   EN reproductive material belonging to the species and artificia l hybrids listed in Annex 
IX with reduced requirements, compared to the requirements of Articles 117 and, 
where applicable, Article 118 and Article 119. 
That authorisation shall be granted, on the basis of a reasoned request submitted by 
the professional operator concerned,  for a specific period of time.  
The label of the forest reproductive materi al made available on the market pursuant 
to this paragraph shall be brown. It shall state that the forest reproductive material 
complies with lower quality requirements than those referred to in Articles 117 and, where applicable, Article 118 and Article 119. 
Member States shall notify the Commission and the other Member States of each 
authorisation granted pursua nt to this paragraph. 
2. The Commission may, by means of implementing acts, require a Member State to 
repeal or amend an authorisation granted pur suant to paragraph 1, if it concludes that 
that authorisation is unnece ssary or not proportionate to the objective of removing 
the temporary difficulties in the general s upply of forest reproductive material. Those 
implementing acts shall be adopted in acc ordance with the ex amination procedure 
referred to in Article 141(3). 
Article 130 
Seed made rapidly available on the market  
In order to make seed of th e current season's crop rapidly available, forest reproductive 
material may be made available on the market  as far as to the first buyer, without the 
information on germination or viability being included on the operator's label pursuant to 
Article 124(2)(b) and (d). The in formation referred to in Article 124(2)(b) and (d) shall be 
provided by the professional ope rator as soon as possible. 
Article 131 
Exemption for small quantities  
1. In the case of seed made available on the market in small quantities, the information 
requirements concerning germination or viab ility as laid down in Article 124(2)(b) 
and (d) shall not apply.  
2. The Commission shall be empowered to adopt  delegated acts, in accordance with the 
Article 140, setting out the maximum size of  the small quantities referred to in 
paragraph 1 for particular categories or sp ecies of forest repr oductive material to 
ensure that the exemption of paragraph 1 is applied in a proportionate manner.  
Article 132 
Emergency measures  
1. Where it is evident that forest reproductive material is likely to constitute a serious 
risk to human, animal and plant health or the environment, and that such risk cannot 
be contained satisfactorily by means of measures taken by the Member State(s) 
concerned, the Commission on its own initiative  or at the request of a Member State, 
shall without delay take any appropriate  interim emergency measures, including 
measures restricting or prohibiting the ma king available on the market of the plant 
reproductive material concerned, depending on the gravity of the situation. Those EN 86   EN measures shall be adopted by means of implementing acts in accordance with the 
examination procedure refe rred to in Article 141(3). 
2. On duly justified imperative grounds of urge ncy to address a serious risk to human 
health, the Commission shall adopt immedi ately applicable implementing acts in 
accordance with the procedure referred to in Article 141(4). 
3. Where a Member State officially inform ed the Commission of the need to take 
emergency measures and the Commission has not acted in accordance with paragraph 1, the Member State concerne d may adopt any appropriate interim 
emergency measures, restricting or prohi biting, within its territory, the making 
available on the market of the forest reproductive material concerned, depending on 
the gravity of the situation. It shall immediately inform th e other Member States and 
the Commission thereof, stating the grounds  for its decision. The Commission may 
adopt implementing acts requiring the Member State to amend or repeal the national 
interim emergency measures. Those im plementing acts shall be adopted in 
accordance with the examination procedur e referred to in Article 141(3). The 
Member State may maintain its national in terim emergency measures until the date 
of application of the implementing act s referred to in this paragraph.  
4. This Article shall apply w ithout prejudice to any meas ures adopted pursuant to 
Article 23(2) of Directiv e 2001/18/EC or Article 34 of Regulation (EC) No 
1829/2003 prohibiting or restricting the cu ltivation of genetically modified 
organisms. 
Article 133 
Temporary experiments  
1. The Commission may decide, by means of im plementing acts, to organise temporary 
experiments in order to identify improved alternatives to any provisions set out in 
Articles 107, 117 and, where applicable , Article 118 and Article 119. Those 
implementing acts shall be adopted in acc ordance with the ex amination procedure 
referred to in Article 141(3). 
2. The implementing acts referred to in paragr aph 1 shall identify the genera or species 
concerned, the conditions of the experiment per genera or species , the duration of the 
experiments, and the monitoring and repor ting obligations of the participating 
Member States. They shall take into account the evoluti on of techniques for 
reproduction, production and control of the concerned material.  
The duration of an experiment shall not exceed seven years. 
Article 134 
Less stringent requirements to conserve genetic resources  
1. Member States may adopt requirements less stringent than those set out in Articles 
107, 117 and, where applicable, Article 118 and Article 119, in the interest of 
conservation and sustainable use of forest genetic resources. In doing so, they shall 
consider the need of producing and making available on the market forest reproductive material which is  naturally adapted to the local and regional conditions 
and threatened by genetic erosion.  
Member States shall submit to the Commission and the other Member States a 
reasoned notification of those measures.  EN 87   EN 2. The Commission may, by means of implementing acts, require a Member State to 
repeal or amend the measures referred to in paragraph 1, if it concludes that those 
measures are not necessary or not proporti onate to the objective of conservation and 
sustainable use of forest genetic resources . Those implementing acts shall be adopted 
in accordance with the examination pr ocedure referred to in Article 141(3). 
TITLE V 
Fees  
Article 135 
Registration and certification fees  
1. Competent authorities shall charge  fees for the following actions: 
(a) registration of approved basic forest material pur suant to Article 112; and 
(b) issuance of a master certifi cate pursuant to Article 122.  
2. The actions referred to in paragraph 1 sh all only be carried out on demand submitted 
by the professional operator to the competen t authority. The demand shall be deemed 
not to have been made if the fees have not  been paid within one  month from the date 
on which the competent authority requested pa yment of the fees and indicated in that 
request the consequences of the failure to pay. 
3. The Commission shall be empowered to adopt  delegated acts, in accordance with the 
procedure referred to in Artic le 140, setting out the specific cost items to be covered 
pursuant to paragraph 1(a) and (b).  
Article 136 
Exemptions from the paym ent of registration fees 
1. Fees provided for in Article 135(1) shall no t directly or indirec tly be refunded, unless 
unduly collected.  
2. Applicants employing fewer than 10 pers ons and whose annual tu rnover or annual 
balance sheet total does not exceed EUR 2 million shall be exempted from the payment of the fees provid ed for in Article 135(1). 
3. The costs referred to in Article 135(3)  shall not include t hose incurred for the 
registration of approved basic forest material and the issu ance of a master certificate 
referred to in paragraph 2. 
TITLE VI 
Imports from and exports of forest reproductive material to third 
countries 
Article 137 
Imports on the basis of Union equivalence  
1. Forest reproductive material may be impor ted from third countries only if it is 
established, pursuant to Artic le 138, that it fulfils requi rements equivalent to those 
applicable to forest reproductive mate rial produced, and made available on the 
market in the Union. EN 88   EN 2. Where seed and planting stock are importe d into the Union, the professional operator 
importing that forest reproductive material  shall inform the respective competent 
authority in advance of the import. 
3. Imported forest reproductive material shal l be accompanied by a master certificate, 
or an official certificate, issued by the thir d country of origin, and records containing 
details of that material provided by the pr ofessional operator in that third country. 
Article 138 
Commission Decision on  equivalence  
1. The Commission may decide, by means of implementing acts, whether forest 
reproductive material of specific genera, species οr categories produced in a third 
country, or particular areas of  a third country, fulfils requi rements equivalent to those 
applicable to forest reproductive material produced and made available on the market 
in the Union, on the basis of:  
(a) a thorough examination of information and data provided by the third country 
concerned pursuant to Article 124( 1) of Regulation (EU) No …/… [ Office of 
Publications, please insert numbe r of Regulation on Official Controls ]; and 
(b) where appropriate, the satisfactory outcome of a control performed in 
accordance with Article 119(1) of Regulation (EU) No …/… [ Office of 
Publications, please insert numbe r of Regulation on Official Controls ]; 
Those implementing acts shall be adopted  in accordance with the examination 
procedure referred to  in Article 141(3). 
2. When adopting the decisions referred to  in paragraph 1, the Commission shall 
consider whether the systems for approval an d registration of basic forest material 
and subsequent production of forest reproduc tive material from that basic forest 
material applied in the thir d country concerned afford the same assurance as those 
provided for in Articles 107 and 117, and, wh ere applicable, Article 118 and Article 
119, for the 'source identified', 'selected',  'qualified' and 'tested' categories. 
3. For the purpose of adopting the decisions referred to in paragraph 1, the Commission 
may apply the provisions of Article  71 of Regulation (EU) No …/… [ Office of 
Publication, please insert numbe r of Regulation on Official Controls ] concerning the 
approval of pre-export controls  carried out by third countries. 
Article 139 
Export from the Union   
1. Where the export of forest reproductive mate rial to a third coun try is governed by an 
agreement with that third country, that e xport shall comply with that agreement.  
2. Where the export of forest re productive material to a third country is not governed by 
an agreement with that country, that export shall take place in accordance with the 
rules of the third country into which that forest reproductive material is to be exported.  
3. Where the export of forest reproductive material to a third country is neither 
governed by an agreement with  a third country nor by the rules of the third country 
into which that forest reproductive material  is to be exported, the requirements for 
production and making available on the mark et of forest repr oductive within the 
Union territory, as set out in Ar ticles 105 to 134, shall apply.  EN 89   EN PART V 
PROCEDURAL PROVISIONS 
Article 140 
Delegated acts  
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article. 
2. The delegation of power referred to in  Articles 11(3), 13(3), 14(3), 15(5), 16(2), 
17(4), 18(4), 18(6), 20(4), 21(5), 23(3), 30(4), 32(1), 33(3), 34(6), 36(4), 38(4), 
39(3), 44(1), 56(5), 56(6), 59(2), 64(4), 65(3), 67(2), 72(2), 74(1), 119, 124(4), 127, 
131(2) and 135(4) and 138(1) shall be conferred on the Commission for an 
indeterminate period of time from the date of the entry into force of this Regulation . 
3. The delegation of power referred to in  Articles 11(3), 13(3), 14(3), 15(5), 16(2), 
17(4), 18(4), 18(6), 20(4), 21(5), 23(3), 30(4), 32(1), 33(3), 34(6), 36(4), 38(4), 
39(3), 44(1), 56(5), 56(6), 59(2), 64(4), 65(3), 67(2), 72(2), 74(1), 119, 124(4), 127, 
131(2), 135(4) and 138(1) may be revoked at any time by the European Parliament or 
by the Council. A decision of revocation sha ll put an end to th e 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 valid ity of any delegated act s already in force. 
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 
5. A delegated act adopted pursuant to Article s 11(3), 13(3), 14(3), 15(5), 16(2), 17(4), 
18(4), 18(6), 20(4), 21(5), 23(3), 30(4), 32(1), 33(3), 34(6), 36(4), 38(4), 39(3), 
44(1), 56(5), 56(6), 59(2), 64(4), 65(3), 67( 2), 72(2), 74(1), 119, 124(4), 127, 131(2) 
135(4) and 138(1) shall enter into force only if no objection has been expressed 
either by the European Parliament or the Council within a period of two months of 
notification of that act to the European Parliament and the Council or if, before the 
expiry of that period, the European Parl iament and the Council have both informed 
the Commission that they will not object. That period shall be extended by two months at the initiative of the Eu ropean Parliament or the Council. 
Article 141 
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 Council. That committee shall be a committee within 
the meaning of Regulation (EU) No 182/2011.  
2. Where reference is made to this para graph, Article 4 of Regulation (EU) No 
182/2011 shall apply. 
Where the opinion of the committee is to be  obtained by writte n procedure, that 
procedure shall be terminated without re sult 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 request. EN 90   EN 3. Where reference is made to this para graph, Article 5 of Regulation (EU) No 
182/2011 shall apply. 
Where the opinion of the committee is to be  obtained by writte n procedure, that 
procedure shall be terminated without re sult 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 request. 
4. Where reference is made to this para graph, Article 8 of Regulation (EU) No 
182/2011, in conjunction with Article 5 thereof shall apply. EN 91   EN PART VI 
FINAL PROVISIONS  
Article 142 
Amendment of Regulation (EC) No 2100/94  
Regulation (EC) No 2100/94 is amended as follows: 
(1) Article 4 is replaced by the following: 
'Article 4 
Union Agency  
1. For purposes of the implementation of this Regulation, a European Agency on 
Plant Varieties, hereinafter referred to  as 'Agency', is hereby established. 
2. The Agency shall carry out the following tasks:  
(a) to offer recommendations on variet y denominations, where requested so 
pursuant to Article 50(2) and 78(2)  of Regulation (EU) No …/… [ Office 
of Publications, please inse rt number of this Regulation ];  
(b) to promote and coordinate de velopment of uniform technical 
examination of varieties, including de velopment of protocols, carried out 
pursuant to Article 71 and, where app licable, the acts a dopted pursuant to 
Article 74 of Regulation (EU) No …/… [Office of Publications, please 
insert number of this Regulation ] 
(c) to carry out audits of competent au thorities, including their premises and 
organisation of work, carrying out tec hnical examinations, as referred to 
in Article 72 of the PRM Regulation;  
(d) to offer, and participate in o ffering, training in its area of mission; 
(e) to provide technical support to the Commission in  the areas within its 
mission; 
(f) to commission studies necessary for the accomplishment of its mission;  
(g) to search for, collect, collate, anal yse and summarise technical data in the 
fields within its mission; 
(h) to ensure that the public and inte rested parties receive rapid, reliable, 
objective and comprehensible information in the fields within its mission; 
(i) to provide technical assistance,  when requested to do so by the 
Commission, with a view to impr oving cooperation between the Union, 
applicant countries, international organisations and third countries, in the fields within its mission; 
(j) to establish, publish and update a database on reference collections of 
varieties.' 
3. The Agency shall also manage a nd support the Union variety register, 
established in accordance with Arti cle 52 of Regulation (EU) No …/… [ Office 
of Publications, please inse rt number of this Regulation ]. It shall implement 
the procedure for the registration of vari eties in the Union va riety register in EN 92   EN accordance with Chapter V of Title IV of Regulation (EU) No …/… [ Office of 
Publications, please insert  number of this Regulation ]'. 
(2) The following Article 4a is inserted: 
'Article 4a 
References to the Community Plant Variety Office (Office)  
References made in this Regulation to the Office and references made in Union 
legislation to the Community Plant Variety O ffice shall be construe d as references to 
the European Agency on Plant Varieties established by Article 4.'  
Article 143 
Penalties  
The Member States shall lay down the rules on pe nalties applicable to infringements of this 
Regulation and shall take all measures necessary  to ensure that they are implemented. The 
penalties provided for must be eff ective, proportionate and dissuasive. 
The Member States shall notify those provisions to the Commission within one year after the 
entry into force of this Regulation and shall notify without delay any subsequent amendments 
of those provisions. 
Article 144 
Repeals   
1. The acts referred to in Annex XIII are hereby repealed. 
2. References to the repealed acts shall be construed as references to this Regulation 
and shall be read in accordance with the correlation table in Annex XIV. 
Article 145 
Transitional Provisions 
1. Member States shall, by [ Office of Publications, please insert date of application of 
this Regulation ], review the measures adopted pur suant to Article 5 of Directive 
66/401/EEC, Article 5 of Directive 66/402 /EEC, Article 4(1) of Directive 
68/193/EEC, Article 7 of Directive 2002/54/ EC, Article 24 of Di rective 2002/55/EC, 
Article 5 of 2002/56/EC and Article 7 of 2002/57/EC, and take one of the following 
actions: 
(a) repeal those measures; or (b) amend those measures to comply with the applicable Union legislation on the 
plant reproductive ma terial concerned. 
2. Member States shall notify to the Commission and the other Member States:  
(a) all measures adopted purs uant to the Directives refe rred to in paragraph 1 by 
[Office of Publications, pleas e insert date of application of this Regulation]; 
and  
(b) any action taken pursuant to point s (a) or (b) of paragraph (1). EN 93   EN Article 146 
Entry into force  
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 [Office of Publications please insert  date counting 36 months from the 
entry into force] . 
This Regulation 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 PresidentEN 94   EN ANNEX I  
 
GENERA AND SPECIES AS REFERRED TO IN ARTICLE 11  
Abies alba Mill.  
Abies cephalonica Loudon  
Abies grandis Lindl.  
Abies pinsapo Boiss.  
Acer platanoides L. 
Acer pseudoplatanus L. 
Agrostis canina L.  
Agrostis capillaris L.  
Agrostis gigantea Roth.   
Agrostis stolonifera L.  
Allium cepa L.  
Allium fistulosum L. 
Allium porrum L.  
Allium sativum L.  
Allium schoenoprasum L.  
Alnus glutinosa Gaertn.  
Alnus incana Moench.  
Alopecurus pratensis L.  
Anthriscus cerefolium (L.) Hoffm.   
Apium graveolens L.  
Arachis hypogaea L.  
Arrhenatherum elatius (L.) P. Beauv. ex J. Presl & C. Presl.   
Asparagus officinalis L. 
Avena nuda L.  
Avena sativa L.(including  A. byzantina K. Koch ) 
Avena strigosa Schreb.   
Beta vulgaris L. 
Betula pendula Roth.  
Betula pubescens Ehrh.  
Brassica juncea (L.) Czern.   
Brassica napus L. 
Brassica nigra (L.) W.D.J. Koch   
Brassica oleracea L.  EN 95   EN Brassica rapa L. 
Bromus catharticus Vahl   
Bromus sitchensis Trin.   
Cannabis sativa L. 
Capsicum annuum L. 
Carpinus betulus L. 
Carthamus tinctorius L. 
Carum carvi L.  
Castanea sativa Mill.  
Castanea Mill. (rootstocks)  
Cedrus atlantica (Endl) Manetti ex Carr.  
Cedrus libani A. Richard  
Cichorium endivia L. 
Cichorium intybus L.  
Citrullus lanatus (Thunb.) Matsum. & Nakai  
Citrus L. 
Corylus avellana L. 
Corylus L. (rootstocks)  
Cucumis melo L.  
Cucumis sativus L. 
Cucurbita maxima Duchesne  
Cucurbita pepo L. 
Cydonia oblonga Mill.  
Cynara cardunculus L. 
Cynodon dactylon (L.) Pers.   
Dactylis glomerata L.  
Daucus carota L. 
Fagus sylvatica L. 
Festuca arundinacea Schreb.   
Festuca filiformis Pourr.   
Festuca ovina L.  
Festuca pratensis Huds.   
Festuca rubra L.  
Festuca trachyphylla (Hack.) Krajina  
xFestulolium Asch. et Graebn.  EN 96   EN Ficus carica L. 
Foeniculum vulgare Mill.   
Fortunella Swingle 
Fragaria L. 
Fraxinus angustifolia Vahl.  
Fraxinus excelsior L. 
Galega orientalis Lam.   
Glycine max (L.) Merrill   
Gossypium L. 
Hedysarum coronarium L.  
Helianthus annuus L. 
Hordeum vulgare L. 
Juglans regia L. 
Juglans L. (rootstocks)  
Lactuca sativa L.  
Larix decidua Mill.  
Larix kaempferi (Lamb.) Carr.  
Larix sibirica Ledeb.  
Larix x eurolepis Henry  
Linum usitatissimum L.  
Lolium × boucheanum Kunth   
Lolium multiflorum Lam.   
Lolium perenne L.  
Lotus corniculatus L. 
Lupinus albus L. 
Lupinus angustifolius L. 
Lupinus luteus L. 
Malus domestica Borkh.  
Malus Mill. (rootstocks)  
Medicago lupulina L.  
Medicago sativa L. 
Medicago × varia T. Martyn   
Olea europaea L. 
Onobrychis viciifolia Scop.  
Oryza sativa L. EN 97   EN Papaver somniferum L.  
Petroselinum crispum (Mill.) Nyman ex A. W. Hill   
Phacelia tanacetifolia Benth.   
Phalaris aquatica L. 
Phalaris canariensis L.  
Phaseolus coccineus L. 
Phaseolus vulgaris L. 
Phleum nodosum L. (formerly Phleum bertolonii DC.) 
Phleum pratense L. 
Picea abies (L.) H. Karst . 
Picea sitchensis (Bong.) Carr.  
Pinus brutia Ten. 
Pinus canariensis C. Smith  
Pinus cembra L. 
Pinus contorta Douglas ex Loud.  
Pinus halepensis Mill.  
Pinus leucodermis Antoine  
Pinus nigra Arnold  
Pinus pinaster Aiton  
Pinus pinea L. 
Pinus radiata D. Don  
Pinus sylvestris L. 
Pistacia vera L. 
Pistacia L. (rootstocks)  
Pisum sativum L.  
Poa annua L. 
Poa nemoralis L. 
Poa palustris L. 
Poa pratensis L. 
Poa trivialis L. 
Poncirus Raf. 
Populus spp. and artificial hybrids between those species  
Prunus amygdalus Batsch   
Prunus armeniaca L. 
Prunus avium (L.) L.  EN 98   EN Prunus cerasus L. 
Prunus domestica L. 
Prunus persica (L.) Batsch  
Prunus salicina Lindley  
Prunus L. (rootstocks)  
Pseudotsuga menziesii (Mirb.) Franco  
Pyrus communis L.  
Pyrus L. (rootstocks)  
Quercus cerris L. 
Quercus ilex L. 
Quercus petraea (Matt.) Liebl.  
Quercus pubescens Willd.  
Quercus robur L. 
Quercus rubra L. 
Quercus suber L. 
Raphanus sativus L.  
Rheum rhabarbarum L.  
Ribes L. 
Robinia pseudoacacia L. 
Rubus L. 
Scorzonera hispanica L. 
Secale cereale L.  
Sicyos angulatus L. (rootstocks)  
Sinapis alba L.  
Solanum lycopersicum Lam.  (formerly  Lycopersicon esculentum Mill. )  
Solanum lycopersicum Lam.x Solanum spp. (rootstocks)  
Solanum melongena L.  
Solanum tuberosum L.  
Sorghum bicolor (L.) Moench   
Sorghum bicolor (L.) Moench  × Sorghum sudanense (Piper) Stapf.   
Sorghum sudanense (Piper) Stapf   
Spinacia oleracea L. 
Tilia cordata Mill.  
Tilia platyphyllos Scop . 
Trifolium alexandrinum L.  EN 99   EN Trifolium hybridum L.  
Trifolium incarnatum L.  
Trifolium pratense L. 
Trifolium repens L. 
Trifolium resupinatum L.  
Trigonella foenum-graecum L. 
Trisetum flavescens (L.) P. Beauv.   
xTriticosecale Wittm. ex A. Camus   
Triticum aestivum L. 
Triticum durum Desf.   
Triticum spelta L. 
Vaccinium L. 
Valerianella locusta (L.) Laterr.  
Vicia faba L.  
Vicia pannonica Crantz   
Vicia sativa L. 
Vicia villosa Roth.  
Vitis L. 
Zea mays L. EN 100   EN ANNEX II  
 
REQUIREMENTS FOR PRE-BASIC, BASIC, CERTIFIED AND STANDARD 
MATERIAL, AND ELEMENTS FOR THE ADOPTION OF THOSE 
REQUIREMENTS  
PART  A 
REQUIREMENTS FOR THE PRODUCTION OF PLANT REPRODUCTIVE MATERIAL AS REFERRED 
TO IN ARTICLE 16(2)   
The following requirements for fields and crops shall apply, depending on the characteristics 
of each genus or species: 
1. Sowing or planting: 
(a) the identity of the plant reproductiv e material, including  where applicable 
mother plants, shall be determined to  ensure the traceability of the plant 
reproductive material. The label of the ma terial or the records on the mother 
plant shall be kept. 
(b) the material shall be planted and /or sowed in a way that there is:  
(i) sufficient distance from pollen sources of the same species and/or the 
same varieties, according to isolatio n rules per botanical characteristics 
and breeding techniques, to ensure  protection from any undesirable 
foreign pollination and to avoid cross pollination with other crops; 
(ii) an appropriate source and level of pollination to ensure the subsequent 
reproduction; 
(iii) an appropriate rotation (pre vious cropping and duration between 
cropping period with the same species) to avoid impurities; 
(c) appropriate attention shall be paid to  the machines and any equipment used to 
ensure absence of weed or other species which are difficult to distinguish at 
seed level in laboratory tests; 
(d) the material shall be sown and planted in a manner to ensure that the presence 
of Union quality pests or th eir vectors, as listed in an implementing act adopted 
in accordance with Article 37(2) of Regulation EU (No) …/… ( Office of 
Publications, please insert number of Regulation on protective measures 
against pests of plants ), complies with the provisions of that act. 
2. Cultivation: 
(a) Off-types shall be absent to ensure varietal identity and purity, and efficient 
production. Where this is not possible due to the characteristics of the plant reproductive material concerned, they sha ll be present up to the lowest possible 
level.  
In case of presence of off-types or ot her plant species, appropriate treatment 
and/or elimination shall be applied to  ensure varietal identity and purity. 
(b) Mother plants shall be treated or ex cluded as a source of reproductive material 
in case of positive test results or visual symptoms of pests or defects. 
(c) Harvesting: EN 101   EN The plant reproductive material shall be  harvested in bulk or as individual 
plants, as appropriate to ensure the identity and purity of the harvested 
material. 
(d) Maintenance: 
Plant reproductive material, including where applicable mother plants, shall be 
maintained in a way to ensure the identity of the variety. That maintenance shall be based on the official descri ption or the officially recognised 
description of the variety.  
(e) Union quality pests 
The plant reproductive material shall be cultivated in a manne r to ensure that 
the presence of Union quality pests, as listed pursuant to the implementing act 
referred to in Article 37(2) of Regulation (EU) No …/… ( Office of 
Publications, please insert number of Regulation on protective measures 
against pests of plants ), in that plant reproductive material complies with the 
provisions of that act. 
(f) Where appropriate, the cu ltivation of plant reproducti ve material shall take 
place separately from the cultivation of material belonging to the same genera 
or species for food or feed purposes, to en sure health of the material concerned. 
(g) Where applicable, micro-propagation may also be used for the reproduction of 
plant reproductive material. 
PART
 B 
REQUIREMENTS FOR THE QUALITY OF PLANT REPRODUCTIVE MATERIAL REFERRED TO IN 
ARTICLE 16(2)   
Plant reproductive material shall fulfil one or more of the following quality requirements, 
depending on the characteristics of each genus or species: 
(a) it shall have minimum germination to allow an appropriate number of plant per 
square meter (m2 ) after sowing, and consequently to secure the yield and quality of 
the production; 
(b) it shall have a maximum content of hard  seed to allow an appropriate number of 
plant per square metre (m2); 
(c) it shall have minimum purity to secure the highest level of varietal identity; (d) it shall have maximum moisture content to  ensure the preservation of the material 
during processing, storage and making available on the market; 
(e) it shall have maximum content of plant reproductive material of other genera or 
species to ensure the lowest presen ce of undesirable plants in the lot; 
(f) it shall have minimum vigour, defined di mension, and specific grading, to ensure 
appropriateness of the materi al and sufficient homogeneity of the lot for sowing or 
planting; 
(g) it shall have maximum presen ce of earth or extraneous matter to prev ent fraudulent 
practices and technical impurities; 
(h) it shall be free from specific defects and damages to ensure quality and health of the 
material; EN 102   EN (i) the presence of Union quality pests, as listed pursuant to the implementing act 
referred to in Article 37(2) of Regulat ion (EU) No […] on protective measures 
against pests, in plant reproductive material shall comply with the provisions of that 
act.  
PART  C 
REQUIREMENTS FOR THE CERTIFICATION OF PLANT REPRODUCTIVE MATERIAL AS 
INDICATED IN ARTICLE 20(1)   
A. Frequency and methods of field inspections  
The frequency of inspections and the relevant growth stage(s) of the plant 
reproductive material for inspections sh all ensure efficient observations and 
inspections. 
The methods for inspections shall be such ensure the reliability of the observations. 
Where applicable, the mother plants shall be inspected, at leas t by visual inspection, 
at the most appropriate period(s) of the y ear to check the presen ce of pests or their 
vectors  
The mother plants shall be maintained in all phases of cultivation under conditions to 
enable the production of plant reproductive material and permit the verification of 
the identity based on the de scription of the variety.  
Inspections shall concern, where appropria te, compliance with the rules set out 
pursuant Article 37(2) of Regulation (EU) No …/… [ Office of Publications, please 
insert number of Regulation on pr otective measures against plants ] concerning the 
presence of quality pests on the plant repr oductive material concerned. The quality of 
soil, substrates, mother plants and the im mediate environment shall be checked to 
avoid presence of pests or their vectors. 
B. Sampling and testing 
1. The sampling method shall fulf il the following requirements:  
(a) the sample to be drawn from a lot shall have the appropriate minimum 
weight for determining content of certa in weeds, to ensure representative 
sampling and suitable size for the analysis of the material to assess whether the quality requirem ents have been fulfilled. 
(b) the intensity of sampling, the equi pment of sampling, and methods to be 
used, shall ensure that reliable samples are collected for testing. 
2. Testing shall be carried out in acco rdance with methods, equipment and 
growing media established per species, as  well as per reference collection for 
purity analysis, to ensure that the quality requirements have been fulfilled. Testing shall include, where appropriate, re testing of germination rate to ensure 
the adequate germination after a certai n period or mixing of plant reproductive 
material. 
3. Inspections shall concern, where appropr iate, compliance with the rules set out 
pursuant Article 37(2) of Regulation (EU) No …/… [O ffice of Publications, 
please insert number of Regulation on protective measures against plants] 
concerning the presence of quality pe sts on the plant reproductive material 
concerned. The quality of soil, substrates, mother plans and the immediate environment shall be checked to avoid presence of pests or their vectors. EN 103   EN PART  D 
ELEMENTS FOR THE ADOPTION OF THE REQUIREMENTS FOR THE PRODUCTION AND 
QUALITY OF PLANT REPRODUCTIVE MATERIAL REFERRED TO IN ARTICLE 16(2),  AND FOR 
THE CERTIFICATION OF PLANT REPRODUCTIVE MATERIAL AS REFERRED TO IN ARTICLE 
20(1)   
The production and quality requirements referred to  in Parts A and B, and the certification 
schemes referred to in Part C, may be laid dow n per one or more of the following elements:  
(a) genera, species, categories, and sub- divisions inside th e category, including 
generations; 
(b) the types of variety or plant reproductive material (heterogeneous material or niche 
market material), including intras pecific or interspecific hybrids; 
(c) the specific uses of th e genera, species, or types of  plant reproductive material 
concerned; 
(d) type of reproduction. EN 104   EN ANNEX III  
PART  A 
CONTENT OF OFFICIAL LABEL AND OPERATOR 'S LABEL AS REFERRED TO IN ARTICLE 21(1) 
The official label and operator's label shall contain the following: 
(a) the botanical name, or names in case of mi xture, of the plant species concerned, in 
roman characters; 
(b) the common name, or names in case of mixt ure, of the plant species concerned in one 
of the official Union languages; 
(c) the two-letter code indicated in norm ISO 3166-1 alpha 222 for the Member State 
and, where appropriate, the name or acr onym of the respective competent 
authority(ies) with which the professional operator is registered;  
(d) the registration number of the registered pr ofessional operator or, in absence of such 
number, the name and ad dress of the operator; 
(e) the lot number of the plan t reproductive material conc erned, and, where relevant, a 
reference to a unique traceability data carri er, such as bar code, hologram or chip; 
(f) the indication of the denomination of the va riety or variety denominations in case of 
mixture components, when making available on the market in refere nce to varieties; 
(g) the indication 'EU rules and standards'; (h) references to the country of production or countries in cas e of mixture, with the two 
letter code referred to in point (c); 
(i) references to declared number of seed s, rootstocks or other units of reproductive 
material, or, where applicable , the net or gross weight; 
(j) indications concerning category of  plant reproductive material and, where 
appropriate, sub-divisi ons of categories; 
(k) references to month and year of labelli ng or references to month and year of last 
sampling; 
(l) the indication, where appropr iate, that th e plant reproductive material belongs to a 
variety with officially recognised descrip tion only, and indication of the region of 
origin of that variety; 
(m) the indication, where appropr iate, that the respective plan t reproductive material is a 
clone or rootstock; 
(n) the indication, where applicab le, that the plant reproductive  material consists of, or 
contains, genetically modified organisms. 
                                                
 
22 ISO 3166-1:2006, Codes for the representation of names of countries and their subdivisions – Part 1: 
Country codes. International Organization for Standardization, Geneva. EN 105   EN PART  B 
INFORMATION TO BE CONTAINED IN THE LABEL FOR GENERA OR SPECIES OTHER THAN THE 
SPECIES LISTED IN ANNEX I , AS REFERRED TO IN ARTICLE 47 
The label shall contain the following: 
(a) the species, indicated with the bo tanical name and in roman characters; 
(b) the common name in one of th e official languages of the Union; 
(c) the denomination of the variety, if the pl ant reproductive material is respectively 
made available on the market with reference to a variety;  
(d) the name and address of the professi onal operator, and its registration number; 
(e) the reference number of the lot given by the operator; (f) declared number of seeds, rootstocks or  other units of reproductive material, or, 
where applicable, the net or gross weight; 
(g) the indication 'EU quality'; (h) the date of the issuance of the label; (i) in the case of import from third countri es, indication of the country of harvesting, 
with the two letter code as referr ed to in point (h) of Part A; 
(j) the place of production; (k) where applicable, the indication that the respective plant re productive material 
belongs to a clone or rootst ock, and the denomination of the variety to which that 
clone or rootstock may belong to; 
(l) where plant reproductive material is pr oduced and made available on the market 
together with forest reproductive material, the respective label of plant reproductive 
material shall indicate 'not for forestry purposes'. EN 106   EN ANNEX IV  
PART  A 
CRITERIA FOR GENERA OR SPECIES WITH SATISFACTORY VALUE FOR CULTIVATION AND /OR 
USE  
The requirements set out in Article 58(2) on satis factory value for cultivation and/or use shall 
apply to genera and species which comply w ith one or more of the following criteria: 
(a) they are of vital importan ce for food and feed security;  
(b) they are of vital importance for food processing, feed proces sing or industrial 
processing; 
(c) they are of vital importance for resi lience and low-input agriculture, including 
organic agricultural production. 
PART  B 
CRITERIA FOR GENERA OR SPECIES WITH SUSTAINABLE VALUE FOR CULTIVATION AND /OR 
USE  
The requirements set out Article 59(1) on sustai nable value for cultivation and/or use shall 
apply to genera and species which comply w ith one or more of the following criteria: 
(a) they are substantially susceptible to pests;  (b) they are subject to particular require ments concerning efficiency of resources;  
(c) they are susceptible to the pr esence of undesirable substances;  
(d) they are susceptible to adaptation to diverse agro-climatic conditions.  EN 107   EN ANNEX V  
 
REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR 
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE 
CERTIFIED AS ‘SOURCE-IDENTIFIED’  
1. The basic material shall be as seed source or stand located within a single Region of 
Provenance. A formal inspection must be made where the material is destined for a specific forestry purpose. 
2. The Region of Provenance and the location and the altitude or altitudinal range of the 
place(s) where the reproductive material is collected must be stated by the 
professional operator concerned to the compet ent authority. It must be stated whether 
the basic material is: 
(a) autochthonous or non-autochthonous  or the origin is unknown; or 
(b) indigenous or non-indigenous or th e origin is unknown. In the case of non-
autochthonous or non-indigenous basic mate rial the origin must be stated if 
known. EN 108   EN ANNEX VI  
 
REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR 
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE 
CERTIFIED AS ‘SELECTED’  
General: The stand will be judged w ith respect to the specific stated purpose for which the 
reproductive material will be inte nded and due importance shall be given to requirements 1- 9, 
depending on the specific purpose. The criteria  used for the selection of the forest 
reproductive material and the purp ose of that materi al shall be indica ted in the National 
Register. 
1. Origin: It must be determined either by hist orical evidence or other appropriate 
means whether the stand is autochthonous/indigenous, non-autochthonous/non-indigenous or the origin is unknown and for non-autochthonous/ non-indigenous 
basic material the origin must be stated if known. 
2. Isolation: Stands must be situated at a suffici ent distance from poor stands, including 
non-autochthonous/nonindigenous or of unknown or igin, of the same species or from 
stands of a related species or variety wh ich can form hybrids with the species in 
question. 
3. Effective Size of the Population: Stands must consist of one  or more groups of trees 
well distributed and sufficiently numerous to ensure adequate inter-pollination. To 
avoid the unfavourable effect s of inbreeding, selected st ands shall consist of a 
sufficient number and density of  individuals on a given area. 
4. Age and Development: Stands must consist of trees of such an age or stage of 
development that the criteria given for the selection can be  clearly judged. 
5. Uniformity: Stands must show a normal degr ee of individual variation in 
morphological characters. Where necessar y, inferior trees shall be removed. 
6. Adaptedness: Adaptation to the ecological conditions prevailing in the Region of 
Provenance must be evident. 
7. Volume production: For the approval of selected stands volume production of wood 
must normally be superior to the accep ted mean under similar ecological and 
management conditions. 
8. Wood Quality: The quality of the wood shall be taken into account. 
9. Form or Growth Habit: Trees in stands must show particularly good morphological 
features, including straightness and circular ity of stem, favourable  branching habit, 
small size of branches and good natural pruni ng. In addition, the proportion of forked 
trees and those showing sp iral grain must be low.  EN 109   EN ANNEX VII  
 
REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR 
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE 
CERTIFIED AS ‘QUALIFIED’  
1. Seed Orchards 
(a) The type, objective, crossing design and field layout, components, isolation and 
location and any changes of these must be approved and registered with the competent authority; 
(b) The component clones or families sha ll be selected for their outstanding 
characters and special consideration sha ll be given to the requirements 4, 6, 7, 
8, 9 and 10 of Annex III; 
(c) The component clones or families shall be planted or shall have been planted 
according to a plan which has been approved by the competent authority and established in such a way that e ach component can be identified; 
(d) Thinning carried out in seed orchards  shall be described together with the 
selection criteria used for such thinning and registered with the competent authority; 
(e) The seed orchards shall be managed and seed harvested in such a way that the 
objectives of the orchards are attained. In the case of a seed orchard intended for the production of an artificial hybr id, the percentage of hybrids in the 
reproductive material must be de termined by a verification test. 
2. Parents of Family(ies) 
(a) The parents shall be selected for thei r outstanding characters and in accordance 
with the requirements 4, 6, 7, 8, 9 and 10 of Annex III, or selected for their combining ability; 
(b) The objective, crossing design and po llination system, components, isolation 
and location and any significant change s of these must be approved and 
registered with the competent authority; 
(c) The identity, number and proportion of the parents in a mixture must be 
approved and registered with the competent authority; 
(d) In the case of parents intended for th e production of an artificial hybrid, the 
percentage of hybrids in the reproductive material must be determined by a 
verification test. 
3. Clones 
(a) Clones shall be identifiable by distin ctive characters which have been approved 
and registered with the competent authority; 
(b) The value of individual clones shall be  established by experience or have been 
demonstrated by sufficiently prolonged experimentation; 
(c) Ortets used for the production of clones shall be selected for their outstanding 
characters and in accordance with the requirements 4, 6, 7, 8, 9 and 10 of 
Annex III. EN 110   EN 4. Clonal Mixtures 
(a) Clonal mixture shall meet the require ments in points 3(a), 3(b) and 3(c); 
(b) The identity, number and proportion of  the component clones of a mixture, and 
the selection method and foundation stoc k must be approved and registered 
with the competent authority. Each mi xture must contain sufficient genetic 
diversity. EN 111   EN ANNEX VIII  
 
REQUIREMENTS FOR THE APPROVAL OF BASIC MATERIAL INTENDED FOR 
THE PRODUCTION OF FOREST REPRODUCTIVE MATERIAL TO BE 
CERTIFIED AS ‘TESTED’ 
1. R EQUIREMENTS FOR ALL TESTS  
(a) General 
The basic material must satisfy the app licable requirements in Annex V or VI. 
Tests set up for the approval of basic ma terial are to be prepared, laid out, 
conducted and their results interpreted in accordance with  internationally 
recognised procedures. For comparative te sts, the forest reproductive material 
under test must be compared with one or preferably several approved or pre-
chosen standards. 
(b) Characters to be examined 
(i) Tests must be designed to assess sp ecified characters and these must be 
indicated for each test; 
(ii) Weight shall be given to adaptati on, growth, biotic and abiotic factors of 
importance. In addition, other characters , considered important in view of 
the intended specific purpose, shall be evaluated in relation to the 
ecological conditions of the region in  which the test is carried out. 
(c) Documentation 
Records must describe the test sites, in cluding location, climate, soil, past use, 
establishment, management and any damage  due to abiotic/biotic factors, and 
be available to the competent authority. Age of the material and results at the 
time of the evaluation must be recorded with the competent authority. 
(d) Setting up the tests 
(i) Each sample of reproductive material shall be raised, planted and 
managed in an identical way as far as the types of plant material permit; 
(ii) Each experiment must  be established in a vali d statistical design with a 
sufficient number of trees in order th at the individual characteristics of 
each component under examination can be evaluated. 
(e) Analysis and validity of results 
(i) The data from experiments must be analysed using internationally 
recognised statistical methods and the results presented for each character examined; 
(ii) The methodology used for the test and the detailed results obtained shall 
be made freely available; 
(iii) A statement of the suggested regi on of probable adaptation within the 
country in which the test was carried  out and characteristics which might 
limit its usefulness must also be given; 
(iv) If during tests it is proved that the reproductive material does not possess 
at least the characteris tics of the basic material, then such reproductive 
material shall be eliminated. EN 112   EN 2. R EQUIREMENTS FOR GENETIC EVALUATION OF COMPONENTS OF BASIC MATERIAL  
(a) The components of the following basic material may be gene tically evaluated: 
seed orchards, parents of family (ies), clones and clonal mixtures. 
(b) Documentation 
The following additional documentation is required for approval of the basic 
material: 
(i) The identity, origin and pedigr ee of the evaluated components; 
(ii) The crossing design used to produce the reproductive material used in the 
evaluation tests. 
(c) Test procedures  
The following requirements must be met: (i) The genetic value of each component  must be estimated in two or more 
evaluation test-sites, at least one of which must be in an environment 
relevant to the suggested use of the reproductive material; 
(ii) The estimated superiority of the reproductive material to be marketed 
shall be calculated on the basis of th ese genetic values and the specific 
crossing design; 
(iii) Evaluation tests and genetic cal culations must be approved by the 
competent authority. 
(d) Interpretation  
(i) The estimated superiority of the re productive material shall be calculated 
against a reference population for a character or set of characters; 
(ii) It shall be stated whether the es timated genetic value of the reproductive 
material is inferior to the re ference population for any important 
character. 
3. R
EQUIREMENTS FOR COMPARATIVE TESTING OF REPRODUCTIVE MATERIAL  
(a) Sampling of the reproductive material 
(i) The sample of the reproductive material for comparative testing must be 
truly representative of the reproduc tive material derived from the basic 
material to be approved; 
(ii) Sexually produced reproductive material for comparative testing shall be: 
harvested in years of good flowering and good fruit/seed production; 
artificial pollination may be utilised, 
harvested by methods that ensure  that the samples obtained are 
representative. EN 113   EN (b) Standards  
(i) The performance of standards used for comparative purposes in the tests 
shall if possible have been known over a sufficiently long period in the region in which the test is to be carried out. The standards represent 
material that has been shown useful fo r forestry at the time that the test 
starts, and in ecological conditions fo r which it is proposed to certify the 
material. They shall come as far as possible from stands selected according to the criteria in Annex III or from basic mate rial officially 
approved for production of tested material; 
(ii) For comparative testing of artificia l hybrids, both parent species must, if 
possible, be included among the standards; 
(iii) Whenever possible several standard s are to be used. When necessary and 
justified, standards may be replaced by the most suitable of the material 
under test or the mean of the components of the test; 
(iv) The same standards will be used in all tests over as wide a range of site 
conditions as possible. 
(c) Interpretation  
(i) A statistically significant superior ity as compared with the standards 
must be demonstrated for at least one important character; 
(ii) It will be clearly reported if there are any ch aracters of economic or 
environmental importance which show significantly inferior results to the standards and their effects must be compensated for by favourable 
characters. 
4. C
ONDITIONAL APPROVAL  
Preliminary assessment of young trials may be the basis for conditional approval. 
Claims of superiority based on an early  assessment must be re-examined at a 
maximum interval of ten years. 
5. E ARLY TESTS  
Nursery, greenhouse and laboratory tests may be accepted by the competent 
authority for conditional approva l or for final approval if it can be shown that there is 
a close correlation between the measured  trait and the characters which would 
normally be assessed in forest field tests. Ot her characters to be tested must meet the 
requirements set out in paragraph 3.  EN 114   EN ANNEX IX  
 
LIST OF TREE SPECIES AND ARTIFICIAL HYBRIDS  
Abies alba  Mill. 
Abies cephalonica Loud. 
Abies grandis Lindl. 
Abies pinsapo Boiss. 
Acer platanoides L. 
Acer pseudoplatanus L. 
Alnus glutinosa Gaertn. 
Alnus incana Moench. 
Betula pendula Roth. 
Betula pubescens Ehrh. 
Carpinus betulus L. 
Castanea sativa Mill. 
Cedrus atlantica Carr. 
Cedrus libani A. Richard 
Fagus sylvatica L. 
Fraxinus angustifolia Vahl. 
Fraxinus excelsior L. 
Larix decidua Mill. 
Larix x eurolepis Henry 
Larix kaempferi Carr. 
Larix sibirica Ledeb. 
Picea abies Karst. 
Picea sitchensis Carr. 
Pinus brutia Ten. 
Pinus canariensis C. Smith 
Pinus cembra L. 
Pinus contorta Loud. 
Pinus halepensis Mill. 
Pinus leucodermis Antoine 
Pinus nigra Arnold 
Pinus pinaster Ait. 
Pinus pinea L. 
Pinus radiata D. Don EN 115   EN Pinus sylvestris L. 
Populus spp. and artificial hybrids between those species 
Prunus avium L. 
Pseudotsuga menziesii Franco 
Quercus cerris L. 
Quercus ilex L. 
Quercus petraea Liebl. 
Quercus pubescens Willd. 
Quercus robur L. 
Quercus rubra L. 
Quercus suber L. 
Robinia pseudoacacia L. 
Tilia cordata Mill. 
Tilia platyphyllos Scop.  EN 116   EN ANNEX X  
 
CATEGORIES UNDER WHICH REPRODUCTIVE MATERIAL FROM THE 
DIFFERENT TYPES OF BASIC MATERIA L MAY BE MADE AVAILABLE ON THE 
MARKET  
Category of forest reproductive material 
(Label colour if colours label or document used) Type of basic 
material Source identified 
(Yellow) Selected 
(Green) Qualified 
(Pink) Tested 
(Blue) 
Seed Source x    
Stand x x  x 
Seed Orchard   x x 
Parents of 
Family(ies)   x x 
Clone   x x 
Clonal Mixture   x x EN 117   EN ANNEX XI  
PART A 
Requirements to be met by fruit and seed lots of the species listed in Annex IX 
1. Fruit and seed lots of the species listed in Annex IX may not be marketed unless the 
fruit or seed lot reaches a minimu m species purity level of 99 %. 
2. Notwithstanding the provisions  of paragraph 1, in the case  of closely related species 
in Annex IX, excluding artificial hybrids, th e species purity of the fruit or seed lot 
shall be stated if it does not reach 99 %. 
PART B 
Requirements to be met by parts of plants of the species and artificial hybrids listed in 
Annex IX 
Parts of plants of the species  and artificial hybrids listed in  Annex IX shall be of fair 
marketable quality. Fair marketable quality sh all be determined by reference to general 
characteristics, health and appr opriate size. In the case of Populus spp. it may be stated that 
the additional requirements set out in Part C are met.  
PART C 
Requirements for external quality standard s for Populus spp. propagated by stem 
cuttings or sets 
1. Stem cuttings 
a. Stem cuttings shall not be considered to be of fair marketable quality, within 
the meaning of Part B, if any of the following defects exist:  
(i) their wood is more than two years old; (ii) they have less th an two well formed buds; 
(iii) they are affected by necroses; (iv) they show signs of desicca tion, overheating, mould or decay. 
b. Minimum dimensions for stem cuttings 
- minimum length: 20 cm,  
- minimum top diameter: Class EC 1: 8 mm 
Class EC 2: 10 mm. 
2. Sets 
a. Sets shall not be considered to be of  fair marketable qu ality if any of the 
following defects exist: 
(i) their wood is more than three years old; (ii) they have less than five well formed buds; (iii) they are affected by necroses; (iv) they show signs of desicca tion, overheating, mould or decay; 
(v) they have injuries other than pruning cuts; 
(vi) they have multiple stems; EN 118   EN (vii) they have excessive stem curvature. 
b. Size classes for sets 
Class Minimum diameter at mid-
length 
(mm) Minimum height 
(m) 
Non-Mediterranean regions   
N1 6 1,50 
N2 15 3,00 
Mediterranean regions   
S1 25 3,00 
S2 30 4,00 
PART D 
Requirements to be met by planting stock of the species and artifici al hybrids listed in 
Annex IX 
The planting stock shall be of fair marketab le quality. Fair marketable quality shall be 
determined by reference to general characteristic s, health, vitality a nd physiological quality. 
PART E  
Requirements to be met by planting stock to  be marketed to the end-user in regions 
having a Mediterranean climate 
Planting stock shall not be marketed unless 95 % of each lot is of fair marketable quality. 
1. Planting stock shall not be considered to be  of fair marketable quality if any of the 
following deficits exist: 
(a) injuries other than pruning cuts or  injuries due to da mage when lifting; 
(b) lack of buds with the pote ntial to form a leading shoot; 
(c) multiple stems; (d) deformed root system; (e) signs of desiccation, overheating, mould or decay; (f) the plants are not well balanced. EN 119   EN 2. Size of the plants 
Species Maximum age 
(years) Minimum 
height 
(cm) Maximum 
height 
(cm) Minimum root 
collar diameter 
(mm) 
     
Pinus halepensis 1 8 25 2 
 2 12 40 3 
     
Pinus leucodermis 1 8 25 2 
 2 10 35 3 
     
Pinus nigra 1 8 15 2 
 2 10 20 3 
     
Pinus pinaster 1 7 30 2 
 2 15 45 3 
     
Pinus pinea 1 10 30 3 
 2 15 40 4 
     
Quercus ilex 1 8 30 2 
 2 15 50 3 
     
Quercus suber 1 13 60 3 
3. Size of the container, where used 
Species Minimum volume 
of the container 
(cm³) 
Pinus pinaster 
Other species 120 
200 EN 120   EN ANNEX  XII 
PART A 
Information to be included in the master certificate of identi ty for reproductive material 
derived from seed sources and stands 
1. Title with the text 'Issued in acco rdance with Regulation EU (No) …/… [ Office of 
Publications, please insert  number of this Regulation ]' 
2. Member State 3. Number of certificate an d code of Member State 
4. The following indication: 'I t is certified that the fo rest reproductive material 
described below has been produced: (a) in  accordance with Regulation EU (No) 
…/… [ Office of Publications, please insert number of this Regulation ]'; (b) under 
transitional arrangements.' 
5. Botanical name 6. Nature of forest reproductive material (see d unit, part of plants or planting stock) 
7. Category of forest reproductive material (source identified, selected or tested) 
8. Type of basic material (seed source or stand) 9. Purpose 10. National register reference or identity of basic mate rial in national register 
11. The indication 'autochthonous', 'non-aut ochthnonous', 'indigenous', 'non-indigenous' 
or 'unknown' 
12. Origin of basic material (for non-auto chthonous/non-indigenous material, if known) 
13. Member State and region of provenance of basic material 
14. Altitude or altitudinal range of site of basic material 
15. Year in which seeds ripened 16. Quantity of forest reproductive material 17. Indication whether the mate rial covered by this certif icate is the result of a 
subdivision of a larger lot covered by a previous Union certificate, and, where 
applicable, indication of pr evious certificate number or  quantity in initial lot 
18. Length of time in nursery 19. Indication on whether there has been subs equent vegetative reproduction of material 
derived from seed 
20. Other relevant information 21. Name and address of professional operator 22. Name and address of competent authority 23. Stamp of competent authority and date EN 121   EN PART B 
Information to be included in the master certificate of identi ty for reproductive material 
derived from seed orchards or parents of family(ies) 
1. Title with the text 'Issued in acco rdance with Regulation EU (No) …/… [ Office of 
Publications, please insert  number of this Regulation ] 
2. Member State 3. Number of certificate an d code of Member State 
4. The following indication: 'I t is certified that the fo rest reproductive material 
described below has been produced: (a) in  accordance with Regulation EU (No) 
…/… [Office of Publications, please insert number of th is Regulation]'; (b) under 
transitional arrangements.'' 
5. Botanical name 6. Nature of basic material (as mentioned in the catalogue) 
7. Nature of forest reproductive material (s eed unit, part of parts or planting stock) 
8. Category of forest reproductive material (qualified or tested) 
9. Type of basic material (seed or chard or parents of family(ies) 
10. Purpose 11. National register reference or identity of basic materi al in the national register 
12. Where appropriate, indication 'autocht honous', 'non-autochthonous', 'indigenous', 
'non-indigenous' or 'unknown' 
13. Origin of basic material (for non-auto chthonous/non-indigenous material, if known) 
14. Member State and region of provena nce or location of basic material 
15. Indication whether seed is derived from open pollination, supplemental pollination or 
controlled pollination 
16. Year in which seed ripened 17. Quantity of forest reproductive material 
18. Indication whether the material covered by the certif icate is the result of a 
subdivision of a larger lot covered by a pr evious Union certificat e (with reference to 
previous certificate number and quantity in initial lot) 
19. Length of time in nursery 20. Number of components represented, incl uding indication of families and clones) 
21. Altitude or altitudinal range of site of basic material 
22. Indication whether genetic modification has been used in the production of the basic 
material 
23. For forest reproductive mate rial derived from parents or  family(ies), indication on 
crossing design and range of percentage composition of component families 
24. Indication whether there ha s been subsequent vegetativ e reproduction of material 
derived from seed, including indication of  method of reproduction and number of 
cycles of reproduction 
25. Indication 'other relevant information' EN 122   EN 26. Name and address of the professional operator 
27. Name and address of the competent authority 28. Stamp of competent authority and date 29. Name and signature of responsible officer EN 123   EN PART C 
Information to be included in the master certificate of identi ty for reproductive material 
derived from clones and clonal mixtures 
1. Title with the text 'Issued in acco rdance with Regulation EU (No) …/… [ Office of 
Publications, please insert  number of this Regulation ] 
2. Member State 3. Number of certificate an d code of Member State 
4. The following indication: 'I t is certified that the fo rest reproductive material 
described below has been produced: (a) in  accordance with Regulation EU (No) 
…/… [Office of Publications, please insert number of th is Regulation]'; (b) under 
transitional arrangements.' 
5. Botanical name  6. Name of clone or clonal mixture 7. Nature of forest reproductive material  (part of plants or planting stock) 
8. Category of forest reproductive material (qualified or tested) 
9. Type of basic material (c lones or clonal mixtures) 
10. Purpose 11. National register reference or identity of basic materi al in the national register 
12. Where appropriate, the i ndication 'autochthonous', 'non-autochthonous', 'indigenous', 
'non-indigenous' or 'unknown' 
13. Origin of basic material (for non-auto chthonous/non-indigenous material, if known) 
14. Member State and region of provena nce or location of basic material 
15. Indication whether the seed derives from  open pollination, supplemental pollination 
or controlled pollination 
16. Year in which seeds ripened 17. Quantity of forest reproductive material 
18. Indication whether the mate rial covered by this certif icate is the result of a 
subdivision of a larger lot covered by a previous Union certificate, and, where 
applicable, indication of pr evious certificate number or  quantity in initial lot 
19. Length of time in nursery 20. Altitude or altitudinal range of site of basic material 
21. Indication whether genetic modification has been used in the production of the basic 
material 
22. Where forest reproductive material derives from parents of family(ies), indication of 
crossing design and range of percentage composition of component families 
23. Indication on whether there has been subs equent vegetative reproduction of material 
derived from seed 
24. Indication 'Other relevant information' 25. Name and address of professional operator EN 124   EN 26. Name and address of competent authority 
27. Stamp of competent authority and date EN 125   EN ANNEX  XIII  
 
REPEALED ACTS AS REFERRED TO IN ARTICLE 144  
1. Directive 66/401/EEC 
2. Directive 66/402/EEC 3. Directive 68/193/EEC 4. Directive 98/56/EC 5. Directive 1999/105/EC 6. Directive 2002/53/EC 7. Directive 2002/54/EC 8. Directive 2002/55/EC 9. Directive 2002/56/EC 10. Directive 2002/57/EC 11. Directive 2008/72/EC 12. Directive 2008/90/EC EN 126   EN ANNEX XIV  
CORRELATION TABLES  
1. Council Directive 66/401/EEC 
Council Directive 66/401/EEC This Regulation Regulation 
(EU) No 
…/…. ( Office 
of 
Publication, 
please insert 
number of 
Regulation on 
Official 
Controls ) Regulation (EU) No 
…/… ( Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants ) 
Article 1 
Article 1a 
Article 2(1), point A Article 2(1), points B, C, D, E 
Article 2(1), points F, G 
Article 2(1a) Article 2(1b) 
Article 2(1d) 
Article 2(2) Article 2(3), (4) 
Article 3(1) 
Article 3(1a) Article 3(2) 
Article 3(3) 
Article 3(4) Article 3a 
Article 4(a) 
Article 4(b) 
Article 4a(1), first subparagraph 
Article 4a(1), second subparagraph Article 4a(2) 
Article 4a(3) 
Article 5 Article 5a 
Article 6 
Article 7 Article 8(1) 
Article 8(2) 
Article 9 Article 1 
Article 3, Article 2 
Article 11(1), (2) Article 16(2), Article 20(2) 
Article 18(5) 
Article 11(3) ─ 
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Article 20(2), Article 24 
Article 12(1) 
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Article 12(2) 
Article 12(3) 
Article 16(3) Article 12(1) 
Article 38 
Article 39 
Article 2 
Article 4 ─ 
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Article 40 Article 20(2) 
Article 75 
Article 20(2), Article 24 Article 17(1) 
Article 17(4), Article 18(5) 
Article 18 ─ 
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─ EN 127   EN Article 10 
Article 10a 
Article 10b 
Article 10c Article 10d 
Article 11 
Article 11a Article 12 
Article 13 
Article 13a Article 14(1) 
Article 14(1a) 
Article 14a 
Article 15 
Article 16 Article 17 
Article 18 
Article 19(1) Article 19(2) 
Article 20 
Article 21 Article 21a 
Article 22 
Article 23 Article 23a 
Article 24 Article 19, Article 21(1) 
Article 18(5) 
Article 18(5) 
Article 18(5) Article 18(4) 
Article 19(4), (5) 
Article 21(1) Article 21(6) 
Article 32, Article 33 
Article 42 Article 4 
Article 40 
Article 20(2), Article 21 
Article 38 
Article 44 Article 35, Article 37 
Article 46 
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Article 16(2), Article 20(2) 
Article 12(4), point (a) Article 145(1), (2) 
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Article 93 
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2. Council Directive 66/402/EEC 
Council Directive 66/402/EEC This Regulation Regulation (EU) 
No …/…. ( Office 
of Publication, 
please insert 
number of 
Regulation on 
Official Controls ) Regulation (EU) 
No …/… ( Office 
of Publication, 
please insert 
number of 
Regulation on 
protective 
measures against 
pests of plants ) 
Article 1 
Article 1a 
Article 2(1), point A Article 1 
Article 3, Article 2 
Article 11(1), (2) ─ 
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─ 
─ EN 128   EN Article 2(1), point B  
Article 2(1), points C, Ca, D, E, F, G, 
H 
Article 2(1a) Article 2(1b) 
Article 2(1c) 
Article 2(1e) Article 2(2) 
Article 2(3), (4) 
Article 3(1) Article 3(2) 
Article 3(3) 
Article 3a 
Article 4(1), first subparagraph (a) 
Article 4(1), first subparagraph (b) Article 4(1), second subparagraph 
Article 4(4) 
Article 4a(1), first subparagraph Article 4a(1), second subparagraph 
Article 4a(2) 
Article 4a(3) Article 5 
Article 5a 
Article 6 Article 7 
Article 8(1) 
Article 8(2) Article 9 
Article 10 
Article 10a Article 11 
Article 11a 
Article 12 
Article 13 
Article 13a Article 14(1) 
Article 14(1a) 
Article 14a Article 15 
Article 16 Article 10(1) 
Article 16(2), Article 20(2)
Article 11(3) 
Article 16(2), Article 20(2) ─ 
─ 
Article 16(2), Article 20(2) Article 20(2), Article 24 
Article 12(1), (2) 
Article 16(2) Article 20(2) 
Article 12(1) 
Article 38 
Article 39 
Article 39  
Article 2 
Article 4 ─ 
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Article 40 Article 20(2) 
Article 75 
Article 20(2), Article 24 Article 17(1) 
Article 17(4), Article 18(5) 
Article 18 Article 19, Article 21(1) 
Article 18(5) 
Article 19(4), (5) Article 21(1) 
Article 21(6) 
Article 32, Article 33 
Article 42 
Article 4 Article 40 
Article 20(2), Article 21 
Article 38 Article 44 
Article 35, Article 37 ─ 
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Article 18 
Article 19(1) 
Article 19(2) Article 20 
Article 21 
Article 21a, Article 21b Article 22 
Article 22a 
Article 23 Article 23a 
Article 24 Article 46 
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Article 141 
Article 16(2), Article 20(2) 
Article 12(4), point (a) Article 57 
Article 145(1), (2) 
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3. Council Directive 68/193/EEC 
Council Directive 68/193/EEC This Regulation Regulation (EU) 
No …/…. ( Office 
of Publication, 
please insert 
number of 
Regulation on 
Official Controls ) Regulation (EU) No 
…/… ( Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants ) 
Article 1 
Article 2(1) 
Article 2(2) Article 3(1) 
Article 3(2) 
Article 3(3), first subparagraph, 
points (a) and (b) and second 
subparagraph 
Article 3(3), first subparagraph, 
point (c) 
Article 3(3), third subparagraph Article 3(4) 
Article 3(5) 
Article 4 Article 5(1) 
Article 5(2) 
Article 5(3) Article 5a 
Article 5b(1) 
Article 5b(2) Article 1 
Article 3 
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Article 12(1), (2) 
─ 
Article 12(1), (2)
 
 
Article 12(4), point (a) 
 
Article 4 
Article 16(2) 
Article 12(1), (2) 
Article 40 Article 51 
Article 14(1) 
Article 15(1), Article 51 Article 56(2), point (a) 
Article 60 
Article 61 ─ 
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─ EN 130   EN Article 5b(3) 
Article 5ba 
 
Article 5c Article 5d(1), (2) 
Article 5d(3) 
Article 5e(1) Article 5e(2), first sentence 
Article 5e(2), second sentence 
Article 5f Article 5g 
Article 7 
Article 8(1) 
Article 8(2) 
Article 9 Article 10(1) 
Article 10(2) 
Article 10(3) Article 10(4) 
Article 10(5) 
Article 10(6) Article 10a 
Article 11(1) 
Article 11(2) Article 12 
Article 12a 
Article 13 Article 14 
Article 14a 
Article 15(1) Article 15(2) 
Article 16 
Article 16a 
Article 16b 
Article 17 Article 17a 
Article 18 
Article 18a Article18b 
Article 19 Article 62 
Article 4, Article 56(1), 
point (b) 
Article 4 Article 71, Article 74 
Article 64(2) 
Article 85(1) Article 103(3) 
Article 52 
Article 53(1), point (h) Article 86 
Article 17(1) 
Article 18(1), (2), (3), (4) 
Article 18(5) 
Article 18 Article 19(1), Article 22 
Article 17(2), Article 29(2) 
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Article 21(4) 
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Article 21(1) 
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Article 45 Article 4 
Article 4 
Article 38 Article 35, Article 36 
Article 42 
Article 46 Article 44 
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4. Council Directive 98/56/EC 
Council Directive 98/56/EC This Regulation Regulation (EU) No 
…/…. ( Office of 
Publication, please 
insert number of 
Regulation on 
Official Controls ) Regulation (EU) No 
…/… ( Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants ) 
Article 1(1) 
Article 1(2), (3) Article 2 
Article 3 
Article 4 Article 5(1) 
Article 5(2) 
Article 5(3), (4) Article 5(5) 
Article 6 
Article 7(1) Article 7(2) 
Article 7(3) 
Article 7(4) Article 8(1) 
Article 8(2), (3) 
Article 8(4) Article 9(1) 
Article 9(2) 
Article 9(3) Article 9(4) 
Article 10 
Article 11(1) 
Article 11(2) 
Article 11(3) Article 11(4) 
Article 12 
Article 13 Article 14 
Article 15 
Article 16 Article 1 
Article 2 Article 3 
Article 6 
Article 4 Article 16(2), Article 48(1) 
Article 64(1) 
Article 16(2) ─ 
Article 5 
Article 7 ─ 
Article 8 
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Article 17, Article 48(2) 
Article 19(4), Article 49 
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Article 50 
Article 50(2), Article 64(4) 
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Article 35, Article 37 
Article 44 
Article 43 
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Article 64(1) Article 93 
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Article 18 
Article 19 
Article 20 Article 21 Article 141 
Article 141 
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5. Council Directive 1999/105/EC 
Council Directive 1999/105/EC This Regulation Regulation (EU) 
No …/…. ( Office 
of Publication, 
please insert 
number of 
Regulation on 
Official Controls ) Regulation (EU) No 
…/… ( Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants ) 
Article 1 
Article 2 
Article 3(1) 
Article 3(2) Article 3(3), first subparagraph 
Article 3(3), second subparagraph  
Article 3(4) Article 4(1) 
Article 4(2) 
Article 4(3), point (a) Article 4(3), point (b) 
Article 4(4) 
Article 4(5) Article 5 
Article 6(1) 
Article 6(2) 
Article 6(3), first subparagraph 
Article 6(3), second subparagraph Article 6(4) 
Article 6(5) 
Article 6(6) Article 6(7) 
Article 6(8) 
Article 7 Article 8 
Article 9 Article 105 
Article 106 
Article 119 
Article 4 Article 105, Article 3(9) 
Article 8(4) 
Article 139 Article 114 
Article 107(1), (2) 
Article 107(3) Article 109 
Article 134 
Article 108 Article 4 
Article 115, point (b) 
Article 117(5) 
Article 118 
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Article 5 
Article 2, point (a) 
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Article 128 ─ 
Article 110 ─ 
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Article 11 
Article 12 
Article 13(1) Article 13(2) 
Article 13(3) 
Article 14(1), (2) Article 14(3) 
Article 14(4) 
Article 14(5) Article 14(6) 
Article 14(7) 
Article 15 
Article 16(1) 
Article 16(2) Article 16(3), (4), (5) 
Article 16(6) 
Article 17(1) Article 17(2) 
Article 17(3) 
Article 17(4) Article 18 
Article 19 
Article 20 Article 21 
Article 22 
Article 23 Article 24 
Article 25 
Article 26 Article 27 
Article 28 
Article 29 
Article 30 
Article 31 Article 112 
Article 113 
Article 122 
Article 123 Article 117(2) 
Article 126 
Article 124(1), (2) Article 130 
Article 131 
Article 125 Article 124(3) 
Article 4 
Article 121 
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Article 128(1), point (b) Article 129 
Article 137, Article 138 
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Article 4 
Article 127 ─ 
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Article 145(1), (2) 
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Article 100(1) ─ 
Article 106(2) 
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 EN 134   EN 6. Council Directive 2002/54/EC 
Council Directive 2002/54/EC This Regulation Regulation 
(EU) No …/…. 
(Office of 
Publication, 
please insert 
number of 
Regulation on 
Official 
Controls ) Regulation (EU) No 
…/… ( Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants ) 
Article 1, first subparagraph 
Article 1, second subparagraph 
Article 2(1) 
Article 2(2) Article 2(3)(A) 
Article 2(3)(B) 
Article 2(4) Article 3(1) 
Article 3(2) 
Article 4 Article 5, first subparagraph, point 
(a) 
Article 5, first subparagraph, point 
(b) 
Article 5, second subparagraph 
Article 5, third subparagraph Article 6(1), first subparagraph, point 
(a) 
Article 6(1), first subparagraph, point 
(b) 
Article 6(1), second subparagraph 
Article 6(2) 
Article 6(3) 
Article 7 Article 8 
Article 9(1) 
Article 9(1a) Article 9(1b) 
Article 9(2) 
Article 10(1) Article 10(2) 
Article 11(1) 
Article 11(2) Article 1 
Article 46 
Article 3, Article 10 
Article 20(2) Article 20(2), Article 23 
Article 20(2), Article 143 
Article 24 Article 12(1), (2) 
Article 20(2) 
Article 12(1) Article 37
 
Article 39
 
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Article 2, points (a) and (b)
 
Article 34(1)
 
Article 4 
Article 34(6) 
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Article 40 Article 75(1) 
Article 20(2), Article 24 
Article 23(1) Article 23(1), point (a) 
Article 20(2) 
Article 17(1) Article 17(4) 
Article 18 
Article 18(4) ─ 
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Article 12(a) 
Article 12(b) 
Article 13 Article 14 
Article 15 
Article 16 Article 17 
Article 18 
Article 19 Article 20 
Article 21 
Article 22(1) 
Article 22(2) 
Article 22(3) Article 23 
Article 24 
Article 25(1) Article 25(2) 
Article 26 
Article 27 Article 28 
Article 29 
Article 30(1), point (a) Article 30(1), point (b) 
Article 30(1), point (c) 
Article 30(2) Article 30A 
Article 31 
Article 32 Article 33 
Article 34 
Article 35 Article 18(5) 
Article 19, Article 21 
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Article 18(5) Article 18(5) 
Article 18 
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Article 21(1) 
Article 21(6) 
Article 42 Article 4 
Article 16(2) 
Article 38(1) 
Article 38(6) 
Article 44(2), point (b)(iii) Article 44 
Article 37 
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Article 16(3) Article 141 
Article 4 
Article 16(2) Article 12(4), point (a) 
 
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Article 145(1) 
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 EN 136   EN 7. Council Directive 2002/55/EC 
Council Directive 2002/55/EC This Regulation Regulation (EU) 
No …/…. ( Office 
of Publication, 
please insert 
number of 
Regulation on 
Official Controls ) Regulation (EU) No 
…/… ( Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants ) 
Article 1, first subparagraph 
Article 1, second subparagraph 
Article 2(1), point (a) 
Article 2(1), point (b) 
Article 2(1), point (c) Article 2(1), point (d) 
Article 2(1), point (e) 
Article 2(1), point (f) Article 2(1), point (g) 
Article 2(2) 
Article 2(3) Article 2(4) 
Article 3(1) 
Article 3(2) Article 3(3) 
Article 3(4) 
Article 4(1) Article 4(2), (3) 
Article 4(4) 
Article 5(1) Article 5(2) 
Article 5(3) 
Article 6 
Article 7(1) 
Article 7(2) Article 7(3) 
Article 7(4), (5) 
Article 8 Article 9(1) 
Article 9(2), (3) 
Article 9(4) Article 9(5) Article 1 
Article 46 
Article 3(5) 
Article 11(2) 
Article 10(7) Article 10(8) 
Article 10(9) 
─ 
Article 18(5) 
Article 11(3) 
Article 53(1), point (i) Article 20(2), Article 24(4) 
Article 14(1) 
Article 51 Article 52 
Article 14(1) 
Article 56(2), point (a) Article 4 
Article 57 
Article 60 Article 61 
Article 62 
Article 14(1) 
Article 71 
Article 74 Article 75 
Article 4 
Article 66, Article 67 Article 51, Article 86 
Article 64 
Article 102(1) Article 53(1), point (h) ─ 
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─ EN 137   EN Article 9(6) 
Article 10(1), (2), (3), (4) 
Article 10(5) 
Article 11 Article 12(1) 
Article 12(2) 
Article 12(3) Article 13(1) 
Article 13(2) 
Article 13(3) Article 13(4) 
Article 14(1), (2) 
Article 15(1) 
Article 15(2) 
Article 15(3) Article 16(1) 
Article 16(2) 
 
Article 17 
Article 18 
Article 19 Article 20(1), (2), (3) 
Article 20(4) 
Article 21 Article 22(a) 
Article 22(b) 
Article 23(1), point (a) Article 23(1), point (b) 
Article 23(2) 
Article 23(3) Article 24 
Article 25(1) 
Article 25(1a) 
Article 25(1b) 
Article 25(2) Article 26(1) 
Article 26(2) 
Article 26(3) Article 27 
Article 28(1) Article 64(1) 
Article 103 
Article 76(3), (4) 
Article 86 Article 82 
Article 83 
Article 84(4) ─ 
Article 85(1) 
Article 81 ─ 
Article 85(1) 
Article 85(1) 
Article 85(2) 
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Article 4 
Article 4, Article 56(1), 
point (c) 
Article 52, Article 53 
Article 41 
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Article 12 
Article 20(2) 
Article 2 Article 37 
Article 39 
Article 2 Article 34(1) 
Article 34(6) 
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Article 40 
Article 16(2), Article 20(2) 
Article 23(1) 
Article 23(1), point (a) 
Article 20(2) Article 17(1) 
Article 18(5) 
Article 32(1) Article 18 
Article 19(1), Article 21 ─ 
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Article 28(3) 
Article 28(4) 
Article 29 Article 30 
Article 31 
Article 32 Article 33 
Article 34(1) 
Article 34(2) Article 35 
Article 36(1) 
Article 36(2) 
Article 36(3) 
Article 37 Article 38 
Article 39 
Article 40 Article 41 
Article 42 
Article 43 Article 44 
Article 45 
Article 46 Article 47 
Article 48 
Article 48(1)(b) Article 49 
Article 50 
Article 51 Article 52 
Article 53 Article 18(5) 
Article 19(4) 
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Article 18(5) Article 21(5) 
Article 21(1) 
Article 21(6) Article 42 
Article 4 
Article 12(1), (2) Article 20(2), Article 21(1) 
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Article 19(1), (2) 
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Article 44 Article 35, Article 37 
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Article 30 Article 20(2), Article 28 
Article 31 
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Article 14(4), Article 56 
Article 16(2), Article 20(2) 
Article 141 Article 4 
Article 32, Article 33 
Article 12(4), point (a) ─ 
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Article 144 Article 145(1), (2) 
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 EN 139   EN 8. Council Directive 2002/56/EC 
Council Directive 2002/56/EC This Regulation Regulation (EU) 
No …/…. ( Office 
of Publication, 
please insert 
number of 
Regulation on 
Official Controls ) Regulation (EU) No 
…/… ( Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants ) 
Article 1, first subparagraph 
Article 1, second subparagraph 
Article 2 
Article 3(1), first sentence 
Article 3(1), second sentence Article 3(1), third sentence 
Article 3(2), (3), (4) 
Article 4 Article 5 
Article 6(1), first subparagraph 
Article 6(1), second subparagraph Article 6(2) 
Article 6(3) 
Article 7 Article 8 
Article 9 
Article 10(1) Article 10(2) 
Article 10(3) 
Article 11(1) Article 11(2) 
Article 12(1) 
Article 12(2) 
Article 12(3) 
Article 13(1) Article 13(2) 
Article 14 
Article 15 Article 16 
Article 17(1) 
Article 17(2), first sentence Article 17(2), second sentence Article 1 
Article 46 
Article 3 
Article 12(1), Article 16(2) 
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Article 16(2) 
Article 12(1) Article 40 
Article 2 
Article 4 ─ 
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Article 20(2) Article 16(2) 
Article 16(2) 
Article 16(2) Article 17(4) 
Article 17(4) 
Article 17, Article 18 Article 18(5) 
Article 18(2), (4) 
Article 18(4) 
Article 18(5) 
Article 19(3), Article 21 Article 18(5) 
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Article 21(1) Article 21(6) 
Article 4 
Article 40 ─ ─ 
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Article 16, Article 31 EN 140   EN Article 18 
Article 19 
Article 20 
Article 21 Article 22(1) 
Article 22(2) 
Article 22(3) Article 23(1) 
Article 23(2) 
Article 24 Article 25 
Article 26 
Article 27(1), point (a) 
Article 27(1), point (b) 
Article 27(1), point (c) Article 27(2) 
Article 28 
Article 29 Article 30 
Article 31 Article 16(2) 
Article 42 
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Article 44 Article 35, Article 37 
Article 34 
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Article 45 
Article 16(2) Article 141 
Article 4 
Article 16(2) 
Article 12(4), point (a) 
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Article 16(2) 
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Article 144 Article 145(1) 
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Article 93 
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9. Council Directive 2002/57/EC 
Council Directive 2002/57/EC This Regulation Regulation 
(EU) No 
…/…. ( Office 
of 
Publication, 
please insert 
number of 
Regulation on 
Official 
Controls ) Regulation (EU) No 
…/… ( Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants ) 
Article 1, first subparagraph Article 1 ─ ─ 
Article 1, second subparagraph Article 46 ─ ─ 
Article 2(1)(a) Article 3, Article 10 ─ ─ 
Article 2(1)(b) Article 11(1), (2), (4) ─ ─ 
Article 2(1)(c), (d), (e), (f), (g), (h), (i), 
(j), (k) Article 16, Article 20 
 ─ ─ 
Article 2(2) Article 11(3) ─ ─ EN 141   EN Article 2(3) ─ ─ ─ 
Article 2(3a) ─ ─ ─ 
Article 2(4)(a) Article 16(2) ─ ─ 
Article 2(4)(b) Article 20(2) ─ ─ 
Article 2(5) Article 20(2) ─ ─ 
Article 2(6) Article 20(2) ─ ─ 
Article 3(1), (2), (3) Article 12(3) ─ ─ 
Article 3(4) 
Article 4 
Article 5, first subparagraph (a) Article 5, first subparagrpah (b) 
Article 5, second subparagraph 
Article 5, third subparagraph 
Article 6(1), first subparagraph, point 
(a) 
Article 6, first subparagraph, point (b) 
Article 6(1), second subparagraph 
Article 6(2) Article 6(3) 
Article 7 
Article 8 Article 9 
Article 10(1) 
Article 10(2) Article 11 
Article 12(1) 
Article 12(2) Article 12(3) 
Article 13 
Article 14 Article 15 
Article 16 
Article 17 
Article 18 
Article 19 Article 19a 
Article 20 Article 16(3) 
Article 12(1) 
Article 37 Article 39 
Article 44 
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Article 2
 
Article 4
 
Article 34 ─ 
─ 
Article 40 Article 75(1) 
Article 20(2) 
Article 17(1), Article 18(1) Article 18(5) 
Article 18 
Article 19(1), Article 20(1) ─ 
Article 21(5), point (g) 
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Article 21(1) 
Article 21(6) 
Article 42 
Article 4 
Article 20(2) ─ 
Article 20(2) 
Article 42  
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─ EN 142   EN Article 21(1) 
Article 21(2) 
Article 21(3) 
Article 22(1) Article 22(2) 
Article 23 
Article 24 Article 25 
Article 26 
Article 27(1), point (a) Article 27(1), point (b) 
Article 27(1), point (c) 
Article 27(2) 
Article 28 
Article 29 Article 30 
Article 31 
Article 32 Article 33 Article 37 
Article 19 
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Article 20(2) Article 141 
Article 4 
Article 16(2) Article 12(4), point (a) 
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Article 57(2) 
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Article 145 Article 145 ─ 
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10. Council Directive 2008/90/EC 
Council Directive 2008/90/EC This Regulation Regulation (EU) No 
…/…. ( Office of 
Publication, please insert 
number of Regulation on 
Official Controls ) Regulation (EU) No 
…/… ( Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants ) 
Article 1(1) Article 1 ─ ─ 
Article 1(2) Article 11(2) ─ ─ 
Article 1(3) Article 4 ─ ─ 
Article 1(4) Article 46 ─ ─ 
Article 2 Article 3 ─ ─ 
Article 3(1) Article 12(1) ─ ─ 
Article 3(2) Article 4 ─ ─ 
Article 3(3) Article 4 ─ ─ 
Article 3(4) Article 2 ─ ─ 
Article 4 Article 16, Article 20 ─ ─ 
Article 5 Article 5 ─ ─ 
Article 6(1) Article 7 ─ ─ EN 143   EN Article 6(2) ─ ─ Article 9(1) 
Article 6(3) Article 8 ─ ─ 
Article 6(4) ─ ─ ─ 
Article 7(1) Article 14, Article 50(1) ─ ─ 
Article 7(2), first 
subparagraph 
Article 7(2), second 
subparagraph Article 14, Article 50(1)
 
Article 12(4), point (a)
 ─ 
 
 
 ─ 
 
 
 
Article 7(3) Article 50(2) ─ ─ 
Article 7(4) Article 57 ─ ─ 
Article 7(5) Article 56  ─ ─ 
Article 7(6) Article 51, Article 52 ─ ─ 
Article 8(1) Article 17(1) ─  ─ 
Article 8(2) Article 17(2) ─ ─ 
Article 9(1), point (a) Article 19 (4), (5) ─ ─ 
Article 9(1), point (b) Article 19 (1), (2) ─ ─ 
Article 9(1), second 
subparagraph Article 21(5) ─ ─ 
Article 9(2) ─ ─ ─ 
Article 9(3) Article 21(1)  ─ ─ 
Article 10 ─ ─ ─ 
Article 11 Article 37 ─ ─ 
Article 12 Article 44 ─ ─ 
Article 13 ─ Article 8 and Article 20, 
point (b) ─ 
Article 14(1) 
Article 14(2) ─ 
─ Article 13(1) 
Article 93 ─ 
─ 
Article 14(3) 
Article 14(4) Article 14(5) 
 
Article 14(6) 
 
Article 14(7) Article 15  
  
 
 
 
 ─ Article 93(3), point (d) 
Article 93(3), point (b) Article 161, point 
(a)(ii)(b) 
Article 161, point 
(a)(ii)(b) 
Article 93 Article 115  
  
 
 
 
 ─ 
Article 16 ─ Article 118 ─ 
Article 17(1) Article 4 ─ ─ 
Article 17(2) Article 40 ─ ─ 
Article 18 Article 11(3) ─ ─ EN 144   EN Article 19 Article 141 ─ ─ 
Article 20 ─ ─ ─ 
Article 21 ─ ─ ─ 
Article 22 Article 144 ─ ─ 
Article 23 Article 145 (1), (2) ─ ─ 
Article 24  ─ ─ ─ 
 
11. Council Directive 2002/53/EC 
Council Directive 2002/53/EC This Regulation Regulation (EU) No …/…. 
(Office of Publication, 
please insert number of 
Regulation on Official 
Controls ) Regulation (EU) No 
…/… ( Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants ) 
Article 1(1) 
Article 1(2) Article 1(3) 
Article 2 
Article 3(1) Article 3(2) 
Article 3(3) 
Article 4(1) Article 4(2) 
Article 4(3) 
Article 4(4), (5) Article 4(6) 
Article 5(1) 
Article 5(2) Article 5(3) 
Article 5(4) 
Article 6 
Article 7(1) 
Article 7(2) Article 7(3) 
Article 7(4) 
Article 7(5) Article 8 
Article 9(1) 
Article 9(2), (3) Article 52(1) 
Article 52(1), point (b) Article 46 
─ 
Article 51 Article 56(3), (4) 
Article 4 
Article 56 Article 56(2) 
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Article 4 Article 57 
Article 60 
Article 61 Article 62 
Article 58 
Article 4 
Article 71 
Article 74 Article 75 
Article 4 
Article 4 Article 67(1), point (i) 
Article 53(1) 
Article 64 ─ 
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Article 9(5) 
Article 9(6) 
Article 10(1), (2), (3), (4) Article 10(5) 
Article 11 
Article 12(1) Article 12(2) 
Article 12(3) 
Article 13(1) Article 13(2) 
Article 13(3) 
Article 13(4) 
Article 14 
Article 15 Article 16(1) 
Article 16(2) 
Article 17 Article 18 
Article 19 
Article 20(1) Article 20(2)and 20(3), point 
(a) 
Article 20(3), point (b) Article 21 
Article 22 
Article 23 Article 24 
Article 25 
Article 26 Article 27 
Article 28 Article 102(1) 
Article 53(1), point (g) 
Article 64(1) 
Article 103 Article 76(3) 
Article 86 
Article 82 Article 83(1), Article 84 
Article 84(4) 
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Article 85(1) 
Article 81 
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Article 85 
Article 85 Article 4 
Article 4, Article 85(1) 
Article 52, Article 55 Article 45, Article 85(1)  
Article 84(4) 
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Article 57 
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Article 141 ─ 
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Article 144 Article 145(1), (2) 
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 EN 146   EN 12. Council Directive 2008/72/EC 
Council Directive 2008/72/EC This Regulation Regulation (EU) No 
…/…. ( Office of 
Publication, please 
insert number of 
Regulation on 
Official Controls ) Regulation (EU) No 
…/… ( Office of 
Publication, please 
insert number of 
Regulation on 
protective measures 
against pests of 
plants ) 
Article 1(1) 
Article 1(2) 
Article 1(3) 
Article 2 
Article 3 Article 4 
Article 5(1) 
Article 5(2) Article 5(3) 
Article 5(4) 
Article 6(1) Article 6(2) 
Article 6(3) 
Article 6(4) Article 7 
Article 8(1) 
Article 8(2), points (a) and (b) Article 8(2), point (c) 
Article 8(3) 
Article 9(1), (2) Article 9(3) 
Article 10(1) 
Article 10(2) 
Article 10(3) 
Article 11(1), first subparagraph Article 11(1), second 
subparagraph 
Article 11(2) Article 12 
Article 13 
Article 14 Article 15 
Article 16 Article 1 
Article 11(1), (2), (4) 
Article 11(3) 
Article 46 
Article 3, Article 10 Article 16(2) 
Article 6 
Article 7, Article 8 ─ 
─ 
Article 5 ─ 
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Article 24 ─ 
Article 5 
Article 2 Article 12(4), point a 
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Article 14(1) Article 52 
Article 17(1) 
Article 17(2) 
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Article 17(1), Article 28 ─ 
 
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Article 35, Article 37 
Article 4 Article 4, Article 40 
Article 43, Article 44 ─ 
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Article 18 
Article 19 
Article 20 Article 21 
Article 22 
Article 23(1) Article 23(2) 
Article 24 
Article 25 Article 26 
Article 27 
 Article 24 
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Article 20, point (d) 
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Article 141 
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Article 4 
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Article 144 Article 145(1), (2) 
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Article 20 
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Article 93 ─ 
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