C(2009)8438

LEGISLATIVE ACT : Commission Regulation 1981/2006/EC on detailed rules for the implementation of Article 32 of Regulation 1829/2003/EC of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms.

CONTENT : Regulation 1829/2003/EC provides for a Community reference laboratory (CRL) to carry out certain duties and tasks set out in that Regulation. It also provides that the CRL is to be assisted by national reference laboratories.

This Regulation lays down detailed rules for the implementation of Article 32 of Regulation 1829/2003/EC as regards:

-the contribution to the costs of the tasks of the Community reference laboratory (CRL) and of the national reference laboratories, as referred to in the Annex to the Regulation; and

-the establishment of national reference laboratories.

Contributions: for each application, a flat-rate contribution of EUR 30 000 must be paid by the applicant to the CRL. Where a full validation procedure of a method of detection and identification for a single GMO event according to the requirements laid down in Annex I of Regulation 641/2004/EC is required, the CRL will request the applicant to pay an additional contribution of EUR 60 000. This amount will be multiplied by the number of GMO events to be fully validated. Where the costs of the validation of the detection method proposed by the applicant substantially exceed these amounts, an additional amount will be requested.

However, the CRL will reduce the amount of the additional contribution, in proportion of the costs saved: where the material needed to perform the full validation procedure is supplied by the applicant; and/or where the applicant provides data that refer to modules, such as DNA extraction protocols, already validated and published by the CRL.

The Regulation sets out circumstances where the contribution will be reduced or exempted, for example, where the applicant is a SME or has its head office established in a developing country.

National reference laboratories: laboratories which assist the CRL in testing and validating the method of detection and identification must fulfil the minimum requirements laid down in Annex I to the Regulation. The laboratories listed in Annex II, are meeting those requirements, and are appointed as national reference laboratories under Regulation 1829/2003/EC to assist the CRL for testing and validating the method of detection. The CRL and the national reference laboratories listed in Annex II must enter into a written agreement to define the relations between them, notably in financial matters.

ENTRY INTO FORCE : 12/01/2007.

32006R1981
OJ L 368 23.12.2006, p. 0099-0109

PURPOSE: to report on the implementation of Regulation 1829/2003/EC.

CONTENT: article 48 of Regulation 1829/2003/EC obliges the Commission to prepare a report on the implementation of the Regulation (and the transitional measures in particular) and what impact the Regulation has had on human and animal health; on consumer protection; on consumer information and on the functioning of the internal market.

To help prepare the report, the Commission compiled a questionnaire, which all of the Member States’ authorities and relevant stakeholders were asked to complete. Having carefully analysed the answers the Commission makes the following findings:

On the implementation of the Regulation:

- By 1 July 2006 the Commission had received 34 applications for authorisation.

- Only one authorisation for a product has been approved in accordance with the procedure set down in the Regulation. It is for food containing, consisting or produced from 1507 maize. It has now been entered on the Community register of GM food and feed.

- By 1 July 2006 the Community Reference Laboratory or CRL, which was set up by the Regulation, had validated 16 methods for the detection and identification of GM food and feed.

- The European Food Safety Authority or EFSA has issued six opinions in relation to the GM authorisation procedure.

- By May 2006, the EFSA had received 26 individual public requests on access to 73 separate applications submitted to the EFSA.

- Of the 26 requests, 18 came from five different NGO’s (mainly environmental). Two accounted for the majority of requests.

- Members from national Parliaments and the European Parliament submitted three requests; national authorities submitted two requests and stakeholders have submitted three requests, for information.

Within the framework of the existing Regulation the Commission will be seeking to create greater transparency and consensus during the authorisation procedure. The Commission, is therefore proposing that the following practices be implemented:

In the scientific evaluation phase: to invite the EFSA to liaise more with national scientific bodies; to request more detailed justifications from the EFSA on its opinions regarding individual applications; and to invite the EFSA to clarify specific protocols on scientific studies.

In the decision making phase: the Commission will address the risk assessment phase by introducing a case by case additional proportionate risk management measure in draft decisions and potentially suspending a procedure if a Member State raises important new scientific questions.

On transitional measures and products legally placed on the market pre-2003:

The Regulation provides transitional measures to allow advanced applications pending at the time of the Regulation’s adoption, to continue under the then existing legislation. The report finds that:

- By 1 July 2006, eight decisions authorising the placing on the market of GM food were adopted in accordance with old legislation (four under Regulation 258/97/EC and four under Directive 18/2001/EC).

- Twenty-six GM products, that were approved prior to the adoption of the 2003 Regulation, have been put on a special Community list and have been approved for use.

On the labelling of GM food and feed:

Currently few “food” products on the EU market are labelled as genetically modified. As such is can be concluded that the Regulation has not had a large impact on the sale of food labelled as genetically modified. According to the results of the sample analysis reported by the Member States, the frequency of non-compliance to the food labelling requirements may be less than 2% - or 113 out of 7 129 samples analysed.

By contrast “compound feed” labelled as genetically modified is much more present on the Community market. This can largely be explained by the predominance of GM soy in the production of soy at world-scale level and the difference of costs between non-GM soy and GM soy. The results of non compliance to the feed labelling requirement across the EU may be around 6% - or 153 out of the 2 478 samples analysed.

On unauthorised products:

A number of unauthorised GM products have entered the EU. They are:

- GM Papaya from Hawaii. These were detected in one Member State on seven occasions. Since July 2005 no further discovery of unauthorised GM papaya has been notified.

- GM Maize Bt10. The US Mission informed the authorities of an accidental release in the US of the unauthorised GM maize Bt10 (erroneously commercialised as Bt11). Between April and September 2005, 1 600 analytical tests were carried out in the US on corn gluten feed intended for export to the EU. The EU Member States carried out a further 1400 controls at the import stage. No positive results were recorded.

- GM rice LL601. The US Mission informed the EU authorities of the accidental release in the US of the unauthorised GM rice LL601. The EFSA concluded that the consumption of imported US long grain rice containing trace levels of LL601 posed an unlikely imminent safety concern to humans or animals.

Information on the unauthorised products was transmitted to the other Member States via the Rapid Alert System for Food and Feed or RASFF. The Commission finds that the RASFF worked as an effective communication tool allowing for timely action.

On the outcome of inspections:

The Food and Veterinary Office of DG SANCO carried out thirteen inspections in the EU Member States. The inspection teams made the following findings:

- all of the Member States inspected have GMO controls on both food and feed;

- all had adequate controls on BT10;

- the majority of infringements related to the mislabelling of food and feed;

- six Member States did not perform sampling controls at the point of entry;

- three Member States performed no sampling controls on seed consignments for the adventitious presence of GMO;

- official GMO laboratories were mostly accredited to ISO standards;

- four Member States had limited or no capabilities regarding the quantification of GMO’s in food or feed; and

- six Member States did not take action in all cases when trace amounts in seed consignments were discovered.

Conclusions: The Commission notes that the Regulation has been operational for short period of time only. Experience, therefore, is limited. This report can only be viewed as preliminary. It is too early to propose any changes to the existing Regulation. A second report will be prepared following a sufficient period of time, which will allow for greater insight into the different aspects of the Regulation’s implementation.

COM(2006)0626
EUR-Lex

32004R0641
OJ L 102 07.04.2004, p. 0014-0025

PURPOSE: to lay down Community procedures for the authorisation, supervision and labelling of genetically modified food and feed.

LEGISLATIVE ACT: Regulation (EC) No 1829/2003/EC of the European Parliament and of the Council on genetically modified food and feed.

CONTENT: This Regulation aims to guarantee a high level of protection for human life and health, animal health, the environment and consumers' interests as regards genetically modified food and feed, while ensuring that the internal market functions properly. It also establishes transparent Community procedures to assess, authorise and monitor genetically modified food and feed and a system for the labelling of genetically modified food and feed.

The main points of the Regulation are as follows:

the provisions of this Regulation also apply to feed intended for animals which are not destined for food production; the new authorisation procedures for genetically modified food and feed include the principles introduced in Directive 2001/18/EC. They also make use of the new framework for risk assessment set up by Regulation (EC) No 178/2002. Genetically modified food and feed will only be authorised for placing on the Community market after a scientific evaluation of any risks which they present for human and animal health and, as the case may be, for the environment. This scientific evaluation is followed by a risk management decision by the Community, under a regulatory procedure ensuring close cooperation between the Commission and the Member States. a product likely to be used both for food and feed purposes will only be authorised when fulfilling authorisation criteria for both food and feed; authorisation may be granted either to a GMO to be used as a source material for production of food or feed and products for food and/or feed use which contain, consist of or are produced from it, or to foods or feed produced from a GMO. Thus, where a GMO used in the production of food and/or feed has been authorised under this Regulation, foods and/or feed containing, consisting of or produced from that GMO will not need an authorisation under this Regulation, but will be subject to the requirements referred to in the authorisation granted in respect of the GMO. Furthermore, foods covered by an authorisation granted under this Regulation will be exempted from the requirements of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients, except where they fall under one or more of the categories referred to in Article 1 in respect of a characteristic which has not been considered for the purpose of the authorisation granted under this Regulation. food additives containing, consisting of or produced from GMOs will fall also within the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure referred to in Directive 89/107/EEC; flavourings which contain GMOs will also fall within the scope of this Regulation for the safety assessment of the genetic modification; -feed materials containing, consisting of or produced from GMOs will fall within the scope of this Regulation and not Council Directive 82/471/EEC; in addition to the authorisation procedure in Directive 70/524/EEC feed additives containing or produced from GMOs will also fall within the scope of this Regulation; this Regulation covers food and feed produced "from" a GMO but not food and feed "with" a GMO. The determining criterion is whether or not material derived from the genetically modified source material is present in the food or in the feed. Processing aids which are only used during the food or feed production process are not covered by the definition of food or feed and, therefore, are not included in the scope of this Regulation. Nor are food and feed which are manufactured with the help of a genetically modified processing aid included in the scope of this Regulation. Thus, products obtained from animals fed with genetically modified feed or treated with genetically modified medicinal products will be subject neither to the authorisation requirements nor to the labelling requirements referred to in this Regulation. harmonised labelling requirements are laid down for genetically modified feed to provide final users, in particular livestock farmers, with accurate information on the composition and properties of feed; despite the fact that some operators avoid using genetically modified food and feed, such material may be present in minute traces in conventional food and feed as a result of adventitious or technically unavoidable presence during seed production, cultivation, harvest, transport or processing. In such cases, this food or feed is not subject to the labelling requirements of this Regulation. A threshold of 0.9% is established for the adventitious or technically unavoidable presence of genetically modified material in foods or feed, both when the marketing of such material is authorised in the Community and when this presence is tolerated by virtue of this Regulation; when the combined level of adventitious or technically unavoidable presence of genetically modified materials in a food or feed or in one of its components is higher than 0.9%, such presence will be indicated in accordance with this Regulation; operators must avoid the unintended presence of GMOs in other products. The Commission will gather information and develop on this basis guidelines on the coexistence of genetically modified, conventional and organic crops. Moreover, the Commission is invited to bring forward, as soon as possible, any further necessary proposal; there are transitional provisions for products already on the market; finally, it should be noted that the traceability and labelling of GMOs at all stages of placing on the market, including the possibility of establishing thresholds, is ensured by Directive 2001/18/EC and Regulation (EC) No 1830/2003.

ENTRY INTO FORCE: 07/11/2003.

Regulation 2003/1829
OJ L 268 18.10.2003, p. 0001-0023

COM(2003)0459
EUR-Lex

T5-0314/2003
OJ C 074 24.03.2004, p. 0099-0576 E

T5-0314/2003

Debate in Parliament

A5-0202/2003

A5-0202/2003

SEC(2003)0376
EUR-Lex

05204/3/2003
OJ C 113 13.05.2003, p. 0031-0058 E

05204/3/2003

06780/2003

2481

2456

COM(2002)0559
EUR-Lex

COM(2002)0559
EUR-Lex

2448

T5-0354/2002
OJ C 271 12.11.2003, p. 0196-0283 E

T5-0354/2002

Debate in Parliament

A5-0225/2002

A5-0225/2002

CES0694/2002
OJ C 221 17.09.2002, p. 0114

CDR0033/2002
OJ C 278 14.11.2002, p. 0031

2377

2371

EUR-Lex
OJ C 304 30.10.2001, p. 0221 E
COM(2001)0425

EUR-Lex
COM(2001)0425