EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 22.4.2015  
COM(2015) 177 final 
2015/0093 (COD) 
  
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
amending Regulation (EC) No 1829/2003 as regards the possibility for the Member 
States to restrict or prohibit the use of genetically modified food and feed on their 
territory 
 EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
Since the entry into force of Regulation (EC) No 1829/20031, there has never been a 
qualified majority amongst Member States in favour of or against a draft Commission Decision authorising Genetica lly Modified Organisms (GMOs) and 
Genetically Modified (GM) food and f eed. The result has always been a “no 
opinion” for all stages of the procedur e (Standing Committee and Appeal Committee 
under currently applicable rules, or the Council in the past). As a result, the 
authorisation decisions have been adopt ed by the Commission, in accordance with 
applicable legislation, without the support of the Member States’ committee opinion. 
The return of the dossier to the Comm ission for final decision, very much the 
exception for the procedure as a whole, ha s become the norm for decision-making on 
GM food and feed authorisations. Regul ation (EC) No 1829/2003 allows Member 
States to adopt measures restricting or prohibiting the use of authorised GMOs and 
GM food and feed only if they are able to demonstrate that the product in question is 
likely to pose risks to health and to the environment. The reasons why Member 
States vote against are diverse. They of ten express national concerns which do not 
only relate to issues associated with the safety of GMOs for health or the 
environment. 
The European Commission was appointed on the basis of a set of Political 
Guidelines presented to the European Parliament. In these Guidelines, a commitment was taken to review the le gislation applicable to th e authorisation of GMOs.  
The results are set out in the Communicat ion reviewing the decision-making process 
on Genetically Modified Organisms (GMOs)
2. 
The Commission concludes that the lega l framework for decision-making on GM 
food and feed needs to be adapted.  
The Commission therefore proposes to extend the solution agreed in Directive (EU) 
2015/4123 by the European Parliament and by the Council on GMO cultivation to 
GM food and feed in respect of democratic choice and in the interest ofconsistency.  
2. THE  CURRENT  LEGISLATIVE  FRAMEWORK  
2.1. Introduction 
The European Union has in place a co mprehensive legal framework for the 
authorisation, traceability and la belling of GM food and feed.  
Regulation (EC) No 1829/2003 on GM f ood and feed covers food, food 
ingredients, and feed containing, consisti ng of or produced from GMOs. It also 
                                                 
1 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed, OJ L 268, 18.10.2003, p. 1. 
2 Communication from the Commission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committe of  the Regions, Reviewing the decision-making 
process on genetically modified organisms (GMOs), COM(2015) 176 final. 
3 Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending 
Directive 2001/18/EC as regards the possibility for Member States to restrict or prohibit the cultivation 
of genetically modified organisms (GMO) in their territory (OJ L 68, 13.3.2015, p. 1). EN 3   EN covers GMOs for other uses su ch as cultivation, if they are to be  used as source 
material for the production of food a nd feed. These different products are 
designated in this document as “GMOs and GM food and feed”.  
Regulation (EC) No 1829/2003 has put in place an authorisation procedure 
whose aim is to ensure that the placing on the market of the products concerned 
will not pose a risk to human and animal health and the environment. In order to do so, a scientific risk assessment is at the centre of the procedure: every authorisation for placing on the market of  a product has to be  duly justified and 
the main ground on which such a justificat ion can rely is sc ientific assessment
4. 
The legislation gives responsibility for th is scientific risk assessment to the 
European Food Safety Authority (EFSA),  in cooperation with the scientific 
bodies of the Member States. 
Regulation (EC) No 1829/2003 contains provisions allowing the Commission 
or Member States to adopt emergenc y measures against the placing on the 
market/use of an authorised GMO, where it appears that the product is likely to 
constitute a serious risk to health or  to the environment. These measures 
require scientific evidence demonstrati ng that the product is  likely to pose a 
serious risk to health or to the environment.  
2.2. The decision-making process for au thorising GMOs and GM food and 
feed 
Regulation (EC) No 1829/2003, read in the li ght of Article 41 of the Charter of 
Fundamental Rights and the case- law of the Court of justice5, requires the 
Commission as risk mana ger to take a decision on an application for 
authorisation in a reasonable  period of time (t o grant an authoris ation or refuse 
an authorisation). 
Since the entry into force of Regulation (EC) No 1829/2003, Member States 
have never expressed a qualified majority  in favour or against a Commission 
draft decision. A “no opinion” (no qualif ied majority in favour or against the 
draft decision) has been expressed at all stages of the procedure (Standing 
committee and Appeal committee under currently applicable rules). As a result, the authorisation decisions have been adopted by the Commission, in 
accordance with applicable legislati on, without the support of the Member 
States' committee opinion. 
The reasons invoked by Member States to justify that they abstained or voted 
against a draft decision of authorisation of a GMO or  a GM food and feed are 
usually not based on science but  on other considerations.  
At the same time, even if Regulation (EC) No 1829/2003 allows the 
Commission to take into consideration, in addition to the risk assessment 
carried out by EFSA, “other legitimate factors”, the Commission has not been 
in a position to refer to those factors in order to justify a refusal of the 
                                                
 
4 Articles 7 and 19 of Regulation (EC) No 1829/2003 provide that the Commission may, in addition to 
EFSA’s opinion, take into account “ other legitimate factors relevant to the matter under 
consideration ”. 
5 CJEU, C-390/99, Canal Satélite Digital SL, par. 41. EN 4   EN authorisation of products considered safe by EFSA6 and, in any case, it could 
only do so for the EU as a whole. 
Until recently, the Union legal framewor k did not allow Member States to 
oppose to the use of GMOs for cultivation and other uses and GM food and feed on their territory by other means than expressing a negative vote during 
the decision-making process leading to  the authorisation of GMOs and GM 
food and feed or, once the authorisa tion is granted, by invoking safeguard 
clauses/emergency clauses. These clauses have been used by some Member States in the case of GMOs for cultivation and, in a more limited way, in the case of GM food and feed. 
Other Member States have made the c hoice to adopt unilate ral bans or “de 
facto” bans, preventing the use of GMOs  for cultivation or GM food and feed 
on their territory or making it subject to  conditions which, being not possible to 
fulfil, lead to the same result. These unilateral measures have been challenged before national jurisdictions or the Court of justice. 
Regarding cultivation of GMOs, Di rective (EU) 2015/412 grants Member 
States, in accordance with the principl e of subsidiarity, more flexibility to 
decide whether or not they wish to cu ltivate GMOs on their territory without 
affecting the risk assessment provided in the system of Union authorisations of 
GMOs. It also covers GMOs for cultivation whose authorisation is pending or which are already author ised under Regulation (EC) No 1829/2003. That 
Directive in no way affects the scienc e-based EU authorisation procedure 
under Directive 2001/18/EC or unde r Regulation (EC) No 1829/2003.  
However, that Directive does not cover GMOs and GM food and feed 
authorised under Regulation (EC) No 1829/2003.  
3. RESULTS
 OF THE  COMMISSION’ S REVIEW  
In line with the Political  Guidelines issued for the Commission on 15 July 2014, the 
Commission Communication COM(2015) 176 final sets out the Commission's 
findings resulting from its review of the decision-making process of GMOs and GM 
food and feed. The Communication conclude s that the current legal framework 
should be amended, by extending the approach  agreed in Directive (EU) 2015/412 to 
other products covered by the Regulation (EC) No 1829/2003. 
Directive (EU) 2015/412 has been adopted ve ry recently. This proposal is largely 
inspired from that Directive, including its objectives and the mechanisms foreseen to 
achieve them. The conclusions drawn by th e Union legislature during the negotiation 
process can thus be applied to this proposal.  
The proposal draws heavily on Directive (E U) 2015/412, and flows directly from the 
political mandate to the Commission on the ba sis of the Political Guidelines it was 
                                                 
6 The use by the Commission of the “other legitimate factors” mentioned in Regulation (EC) 
No 1829/2003, to refuse to grant the authorisation coul d be legally defensible if justified by overriding 
reasons of public interest of the same nature as those mentioned in Article 36 TFEU and related case-
law of the Court of justice (see for instance, CJEU , 20.02.1979, Case 120/78 Rewe-Zentral (Cassis de 
Dijon) [1979] ECR 649) and by objectives of genera l interest as referred to in Article 52(1) of the 
Charter of fundamental rights of the European Union and relevant Court’s case-law (see for example 
CJEU, 12.07.2012, Case C-59/11, Asso ciation Kokopelli, ECLI:EU:C:2012:447). EN 5   EN elected on. As in the case  of Directive (EU) 2015/412, th e practical effect of the 
proposal will depend on the extent to which Member States make use of its provisions. 
4. LEGAL
 ELEMENTS  OF THE  PROPOSAL  
4.1. Summary of the proposal 
The Commission proposal amends Re gulation (EC) No 1829/2003, under the 
ordinary legislative procedure, to introduce new provisions allowing Member 
States to restrict or prohibit the use of GMOs and GM food and feed covered 
by the GMO legal framework, in part or all of their territory, in complement to 
the possibilities already offered to Memb er States with respect to GMOs for 
cultivation by Directive (EU) 2015/412. 
The additional powers granted to Memb er States under this proposal will only 
concern the possibility to adopt measures  in accordance with the Treaty to 
restrict or prohibit the use of GMOs and GM food and feed on their territory 
after these products have been authorised. It will thus not affect the procedural 
and substantial conditions of the author isation of GMOs and GM food and feed 
under Regulation (EC) No 1829/2003, whic h will remain valid for the whole 
territory of the Union.  
The measures adopted by Member States need to be compatible with the 
internal market, and in particular Arti cle 34 TFEU which prohibits measures of 
equivalent effects to quan titative restrictions to the free movement of goods. 
That is why the Member States making us e of this proposal will need to justify 
the measures taken based on grounds to be in accordance with Article 36 TFEU and the notion of overriding reasons of public interest  as developed by 
the case-law of the Court of justice. In addition, the measures envisaged will need to be reasoned and to be compatible  with the principles of proportionality 
and non-discrimination between nationa l and non-national products. Finally 
these measures will need to comply w ith the international obligations of the 
Union. 
It will be up to each Member State wa nting to make use of  this "opt-out" to 
justify the restriction or prohibition on a case-by-case basis, taking into account 
the GMO in question, the type of m easure envisaged, and the specific 
circumstances at national or regional le vel that justify su ch an opt-out.  
As for Directive (EU) 2015/412, Member St ates will not be allowed to use 
justifications linked to the assessment of risks to health or to the environment 
which are comprehensively addressed in  the authorisation decision and by the 
procedures already available in Regu lation (EC) No 1829/2003, to address new 
risks (e.g. “emergency measures” under Article 34 or “supervision” under 
Articles 9 and 21). 
The new possibility offered by the propos al does not cover the placing on the 
market and use of products not labelled as genetically modified, in accordance 
with labelling thresholds set under the GMO legal framework (e.g. under 
Articles 12 and 24 of Regulation (EC)  No 1829/2003 food and feed containing 
an adventitious or technically unavoidab le presence of GM material up to 0,9% 
by ingredient are not labelled). EN 6   EN The Member States which will restrict or prohibit the use of GMOs and GM 
food and feed already on the market will al so have to preserve  the rights of the 
operators, by providing them a reasonable period of time to allow the phasing 
out of the products concerned.  
 
4.2. Legal basis 
The proposal is based on Article 114 TF EU which is, among the legal basis of 
Regulation (EC) No 1829/2003, the legal basis which is relevant for the 
adoption of the measures provided for in this proposal.  
4.3. Subsidiarity and prop ortionality principles  
4.3.1. Conformity of the proposal with  the principle of subsidiarity  
According to Article 5(3) TEU, under the principle of subsidiarity, in 
areas not falling within its exclusive competence, the Union shall act only if and in so far as the objectiv es of the proposed action cannot be 
sufficiently achieved by the Member Stat es, either at central level or at 
regional and local level, but rather, by reason of the scale of effects of the 
proposed action, be better achieved at Union level.  
The current Union legal framework fully harmonises the authorisation 
procedure of GMOs and GM food and feed and allows Member States to 
adopt measures restricting or prohi biting the use of GMOs and GM food 
and feed only under the conditions set out in that legal framework. Currently, that framework contains  limited possibilities for Member 
States to express other considerati ons than those associated with the 
safety of the product, outside their vote in the committees.  
The proposal will change this situati on as it enables Member States to 
adopt on their territory measures to re strict or prohibit the use of GMOs 
and GM food and feed, based on legi timate considerations other than 
those linked to the safety of the pr oducts, provided that those measures 
are in line with EU law. 
In accordance with Article 5(3) TEU, the proposed amendments do not 
affect the provisions of Regulat ion (EC) No 1829/2003 pursuing an 
objective which is better achieved at Union level. This is the case of the Union procedure of authorisation, ba sed on risks, and of the provisions 
which allow uniform and coordinate d Union actions against potential 
risks caused by GMOs, such as the pr ovisions on emergency measures or 
the provisions on supervision, all of them aiming at ensuring a high level 
of safety throughout the Union. In Directive (EU) 2015/412 the European Parliament and the Council recalled th at this objective is better achieved 
at Union level, and ha ve thus prohibited Memb er States to adopt 
measures interfering into these matters
7. 
                                                 
7 Its recital 2 provides that “a uniform high level of protection of health, the environment and the 
consumers should be achieved and maintained throughout the territory of the Union”  whereas 
according to its recital 14: “the level of protection of  human or animal health  and of the environment 
chosen in the Union allows for a uniform scientific assessment throughout the Union and this Directive 
should not alter that situation.” EN 7   EN However, for issues which are not linke d to the risks to health and to the 
environment, the proposal is base d on the underlying assumption that 
national, regional or local levels of decision-making are the most 
appropriate levels to address the particularities linked to the use of GMOs and GM food and feed in the different territories of the Union. In view of 
the variety of situations which can  be covered by the proposal, it was 
considered not appropriate to tr y to identify more precisely the 
justifications which could be used  by Member States to support their 
measures, provided that they are compatible with Union law.  
This approach is in line with the principle of subsidiarity. 
4.3.2. Conformity of the proposal with  the principle of proportionality
 
According to Article 5(4) TEU, under th e principle of pr oportionality, the 
content and form of Union action sha ll not exceed what is necessary to 
achieve the objectives  of the Treaties. 
The proposal is limited to only allow Member States to adopt reasoned 
measures on their territory on the us e of GMOs and GM food and feed 
authorised under the GMO legal framework.  
It does not affect the Union proced ure of authorisa tion based on risks 
which should remain harmonised at Un ion level in orde r to maintain a 
same level of safety throughout the EU. To avoid interference with the 
procedures of the GMO legal framework which allows the Union and its Member States to react in a quick and coordinated way in the case where a risk to health or to the environment is identified after the GMO has been authorised, Member States are not authorised to base their measures on grounds linked to the safety of the product. 
Other mechanisms are provided to en sure that the proposal does not go 
beyond what is necessary to at tain the objective pursued.  
Indeed, to ensure that the measures adopted by Member States will be 
limited to what is needed to achie ve the objective pursued, the proposal 
does not allow Member States to restrict or prohibit the use of products which do not have to be labelled under the GMO legal framework, even if they may contain a small proporti on of GMOs or GM food and feed 
below the thresholds set out therein. Provisions are also established to 
protect the rights of economic operato rs which lawfully placed on the 
market a GMO or a GM food and feed  before the Member State adopt 
measures pursuant to the proposal. 
The proposal also foresees that the measures adopted by Member States 
have to be reasoned, based on co mpelling grounds compatible with 
Articles 34 and 36 TFEU a nd related case-law of th e Court of justice and 
that they have to respect the pr inciples of proportionality and non-
discrimination. 
These different elements ensure that the proposal does not exceed what is 
necessary to attain the objective purs ued and that it is compatible with 
the principle of proportionality. EN 8   EN 4.4. Choice of instruments 
It is proposed to amend  Regulation (EC) No 1829/ 2003 by a Regulation, by 
application of the principle of "parallélisme des formes". The Commission's obligation to monitor the application of  the Regulation in terms of impact on 
inter alia health and the functioning of the internal  m a r k e t  a s  s e t  o u t  i n  
Regulation (EC) No 1829/ 2003 on GM food and feed
8, will continue to apply 
and will include the amending provisi ons proposed with this Regulation. 
5. BUDGETARY  IMPLICATION 
No 
                                                 
8 See Article 48(2) of the Regulation. EN 9   EN 2015/0093 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
amending Regulation (EC) No 1829/2003 as regards the possibility for the Member 
States to restrict or prohibit the use of genetically modified food and feed on their 
territory 
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 114 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 Eu ropean Economic and Social Committee
9,  
Having regard to the opinion of  the Committee of the Regions10,  
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) Directive 2001/18/EC
11 and Regulation (EC) No 1829/200312 (hereafter “the GMO 
legal framework”), establish a comprehe nsive legal framework for granting the 
authorisations for the placi ng on the market of genetically modified organisms 
(GMOs) and genetically modified  food and feed. The aim of these acts is to ensure the 
safety of GMOs and genetically modified (G M) food and feed, while  at the same time, 
establishing an internal market for those products. 
(2) Both Directive 2001/18/EC and Regulati on (EC) No 1829/2003 esta blish a centralised 
procedure at Union level whereby th e Commission is empowered to adopt 
implementing decisions granting or refusing a pplication for the authorisation of GMOs 
and GM food and feed, based on an assessment  of the potential risk s that they could 
pose to human or animal health, or th e environment. Regulation (EC) No 1829/2003 
also provides that other legitimate factors may be taken into account, where 
appropriate. 
(3) Commission implementing decisions concer ning authorisations for GMOs and GM 
food and feed are adopted in accordance with  the examination procedure provided for 
                                                 
9 OJ C , , p. . 
10 OJ C , , p. . 
11 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the 
deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1). 
12 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1). EN 10   EN in Regulation (EU) No 182/201113. That procedure provides th at Member States are to 
be involved at two stages, namely in the st anding committee and later, if necessary, in 
the appeal committee.  
(4) The use of genetic engineering in plants  and in food and feed is a subject which 
divides opinion in the Member States and this is reflected in the decision-making 
process leading to the author isation of GMOs and GM food and feed. Since the date of 
application of Regulation (EC) No 1829/ 2003, the results of the voting in the 
committees or in Council show that there has never been a qualified majority either in 
favour of or against the author isation of those products. Ther efore, authorisations have 
been adopted by the Commission at the end of the procedure, in accordance with 
applicable legislation, wit hout the support of the Member States' committee opinion. 
(5) Once a GMO or a GM food and feed is authorised in accordance with Directive 
2001/18/EC or Regulation (EC) No 1829/2003, th e Member States may not prohibit, 
restrict or impede the free circulation of th at product within their territory, except in 
accordance with strict conditions which ar e laid down by Union law –and require to 
provide evidence of a severe risk to hea lth or to the environment. Some Member 
States have had recourse to the safeguard clauses and the emergency measures 
provided for respectively in Articles 23 of Directive 2001/18/EC and Article 34 of 
Regulation (EC) No 1829/ 2003. Other Member States have made use of the 
notification procedure provided for in Article 114(5) and (6) of TFUE which also is 
required to be based on ne w scientific evidence relating to the protection of the 
environment or the working environment. Other Member States have adopted unilateral prohibitions. Some of  these measures have been challenged before national 
jurisdictions or the Court of justice. 
(6) That situation was changed recently as regards GMOs for cultivation due to the 
adoption, on 13 March 2015, of Directive (EU) 2015/412
14 which amended Directive 
2001/18/EC to allow Member States to restri ct or prohibit the cultivation of GMOs in 
their territory. The new provisi ons are primarily aimed at enabling Member States to 
decide whether or not they wish to permit the cultivation of GMO crops on their territory, without affecting the risk assessment provided in the system of Union 
authorisations of GMOs. They were intend ed to provide more predictability to 
operators and limit the recourse by the Me mber States to the safeguard clauses 
provided for in Article 23 of Directive 2001/18/EC and 34 of Re gulation (EC) No 
1829/2003. It was also expected that those am endments would have a positive impact 
on the decision-making process for the authorisation of GMOs for cultivation. 
(7) The reasons for the amendments made to Directive 2001/18/EC, by Directive (EU) 
2015/412 as regards GMOs for cultivation are also relevant for other GMOs and GM 
food and feed covered by Regulation (EC)  No 1829/2003. Indeed, the results of the 
vote on the implementing decision for th e authorisation of products covered by 
Regulation (EC) No 1829/2003 wh ich are not intended for cultivation in the relevant 
committee, or in the Council, is always “no opinion” (no qualified majority either in 
favour of or against the author isation) and there are also Member States in which the 
                                                
 
13 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 
laying down the rules and general principles concerni ng mechanisms for contro l by Member States of 
the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). 
14 Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending 
Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the 
cultivation of genetically modified organisms (GMOs)  in their territory (OJ L 68, 13.3.2015, p. 1). EN 11   EN use of these products is prohibited. Taking t hose matters into account, it is appropriate 
to amend Regulation (EC) No 1829/2003 in or der to provide the possibility for the 
Member States to restrict or  prohibit the use of GMOs and GM food and feed in all or 
part of their territo ry, on the basis of compelling grounds  compatible with Union law - 
not related to risks to human and animal h ealth and to the environment, as those are 
already assessed at Union level, pursua nt to Regulation (EC) No 1829/2003. This 
possibility should not apply to GMOs for cultivation which are already covered by the amendments made to Directive 2001/18/EC, by Directive (EU) 2015/412. 
(8) Member States should therefore be al lowed to adopt measures restricting or 
prohibiting the use in all or part of their te rritory of a GMO or a GM food and feed, or 
group of GMOs or of GM food and feed, on ce authorised, provided that such measures 
are reasoned, based on compe lling grounds in accordance wi th Union law, and are in 
line with the principles of proportionality and non-discri mination between national and 
non-national products, and Article 34, Artic le 36 and Article 216(2) of TFEU. 
(9) The restrictions or prohib itions adopted pursuant to this Regulation should refer to the 
use and not to the free circulation and impor ts of genetically m odified food and feed. 
(10) The level of protection of  human and animal health a nd of the environment achieved 
through the authorisation pr ocedure provided for by Regulation (EC) No 1829/2003 
requires a uniform scientific assessment  throughout the Union and this Regulation 
should not alter that situation. Therefor e to avoid any interference with the 
competences which are granted to the ri sk assessors and ri sk managers under 
Regulation (EC) No 1829/2003, Member States  should not be au thorised to use 
grounds which are related to risks to health  and to the environment which should be 
dealt with in accordance with the procedure already established in Regulation (EC) No 
1829/2003, and in particular its Articles 10, 22 and 34. 
(11) Member States’s measures adopted pursuan t to this Regulation should be subject to a 
procedure of scrutiny and information at Union level  with a view to the functioning of 
the internal market. In light of the level of scrutiny and information provided in this 
Regulation, it is not nece ssary to provide, in additi on, for the application of 
Directive 98/34/EC of the Europ ean Parliament and of the Council
15. The amendments 
being made to Regulation (EC) No 1829/2003 by this Regulation provide that Member 
States may restrict or prohibit the use of GMOs  or GM food and feed in all or part of 
their territory for the whole duration of the authorisation, provided that an established 
standstill period, during whic h the Commission and the othe r Member States are given 
the opportunity to comment on the proposed measures, has elapsed. The Member State 
concerned should therefore communicate a dr aft of those measures  to the Commission 
at least 3 months prior to their adoption, in order to gi ve the opportunity to the 
Commission and the other Member States  to comment, and should refrain from 
adopting and implementing those measures dur ing that period. On the expiry of the 
established “standstill” period, the Member State should be able to adopt the measures 
as originally proposed or amended to take into account the Commission's or the Member States’ comments. Member States  should be allowed to notify to the 
Commission measures pursuant to this Regul ation before that the product concerned 
                                                
 
15 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a 
procedure for the provision of information in the field of technical standards and regulations and of 
rules on Information Society services (OJ L 204, 21.7.1998, p. 37). EN 12   EN by the measures is authorised so that the restriction or the prohibition starts its effects 
as from the date of entry into force of the Union authorisation. 
(12) In the case where a produc t was lawfully used before a Member State adopts measures 
pursuant to this Regulation, sufficient time s hould be given to operators to allow the 
phasing out of the product from the market. 
(13) Measures adopted pursuant to this Regula tion, which restrict or prohibit the use of 
GMOs or GM food and feed should not affect the use in other Member States of these 
products as well as of products derived fr om their consumpti on. In addition, this 
Regulation and the national m easures adopted pursuant to  it should be without 
prejudice to Union law requi rements concerning unintended and adventitious presence 
of GM material in other products and shoul d not affect the placing on the market and 
use of products complying with these requirements. 
(14) Regulation (EC) No 1829/2003 should be amended accordingly, 
HAVE ADOPTED THIS REGULATION: 
Article 1 
In Regulation (EC) No 1829/2003 the following Article is inserted: 
“Article 34a 
Restrictions or prohibitions by Member States 
1. Member States may adopt measures rest ricting or prohibiting the use of products 
referred to in Article 3(1) and 15(1) aut horised pursuant to th is Regulation provided 
that such measures are: 
(a) reasoned and based on compelling grounds in accordance with Union law 
which shall, in no case, conflict with th e risk assessment carried out pursuant 
this Regulation; 
(b) proportional and non-discriminatory. 
2. Where a Member State intends to adopt meas ures as provided for in paragraph 1, it 
shall first submit to the Commission a draf t of those measures, and the corresponding 
justification. The Commission shall immedi ately notify to the other Member States 
the draft measures and the corresponding justification. The Member State may 
submit the draft measures and such inform ation before the authorisation procedure 
provided for in Articles 7 and 19 has been completed.  
During a period of 3 months from the date  of submission to the Commission of the 
draft measures and information in accordance with the first subparagraph: 
(a) the Member State shall refrain from adopting and implementing those 
measures; 
(b) the Commission and the Member St ates may make any comments they 
consider appropriate to the Member State which has submitted the draft measures.  
3. Measures adopted in accordance with paragr aph 1 of this Article shall provide for a 
reasonable period of time during which existi ng stocks of the products referred to in 
Article 3(1) and 15(1) concerned by such  measures, which could legally be used 
before the date of adoption of the measures, may be used up. EN 13   EN 4. Measures adopted in accordance with paragr aph 1 of this Article shall not affect the 
use, in the Member State concerned, of f ood and feed containing an adventitious or 
technically unavoidable presence of gene tically modified material which, by 
application of the thresholds  set out in Articles 12 and 24, are not required to be 
labelled in accordance with this Regulation.  
5. Paragraph 1 to 4 of this Article shal l not apply to GMOs for cultivation.”  
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union.  
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 President