COMMISSION REGULATION (EC) No 1981/2006
of 22 December 2006
on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 32, fifth sub-paragraph, thereof,
Whereas:
(1)
Regulation (EC) No 1829/2003 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.
(2)
Methods of detection and identification which have to be tested and validated by the CRL and samples and control samples have to meet the requirements laid down in Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (2).
(3)
It is necessary to provide detailed rules for implementing Article 32 of Regulation (EC) No 1829/2003.
(4)
The financial contribution to be paid by applicants in accordance with Article 32 of Regulation (EC) No 1829/2003 should be used only towards supporting the costs of the duties and tasks as set out in the Annex to that Regulation. The CRL should be authorised to charge a financial contribution to applicants for new authorisations, for renewal of authorisations and in the case of modification of authorisations where appropriate.
(5)
The determination of the amount of the financial contribution should take into account the burden of work to be carried out by the CRL in each case, depending on the level of method testing and validation already carried out prior to the submission of the application for authorisation.
(6)
Applicants should be encouraged to provide data that refer to modules which have already been validated and published by the CRL in order to facilitate both the establishment of the application dossier and the validation of the detection method.
(7)
A financial contribution should be levied on a flat-rate basis in order to contribute to supporting the costs incurred in the comprehensive data analysis and in-house laboratory verification of the method and samples received to be carried out by the CRL in all cases where a new method is submitted.
(8)
An additional financial contribution should be charged to applicants where the validation of the proposed method requires the performance of a collaborative study involving national reference laboratories in order to comply with the criteria referred to in Annex I of Regulation (EC) No 641/2004.
(9)
The amount of the financial contributions should cover the costs directly associated with the validation tasks to be performed. Those include in particular the manpower, the reagents and other associated disposable material, the distribution of material to members of the European Network of GMO laboratories (ENGL) where appropriate and the administrative costs. They should be calculated on the basis of the experience gained by the Commission’s Joint Research Centre in carrying out validations of detection methods, including collaboration with members of the ENGL where appropriate, and should not exceed the actual costs incurred in carrying out that validation.
(10)
Where the validation costs for a specific application for authorisation exceeds substantially the amount of the financial contributions provided for in this Regulation, the CRL should be able to charge an additional contribution to the applicant. In that case, the applicant should have the right to be exempted from the payment of the additional contribution if he withdraws its application within a set time limit.
(11)
Due consideration should be given to the specific case of biotechnological research originating in developing countries. A reduction of the amount of the financial contribution should therefore be provided where the head office of the applicant for authorisation is established in a developing country.
(12)
In order to facilitate the participation of small and medium-sized enterprises (SMEs) to the Community procedure for authorisation of genetically modified (GM) food and feed, it is appropriate to provide for a reduced financial contribution where applicants are SMEs. The model declaration on the information relating to the qualification of an enterprise as an SME (3) could serve for the written evidence to be provided by applicants as to their SME status.
(13)
Regulation (EC) No 1829/2003 already lays down the rule that applicants should make a financial contribution, so any applicants who have lodged applications before the entry into force of this Regulation will be aware of this rule. Consequently, the financial contribution should also be required for applications for authorisation submitted before the date of entry into force of this Regulation.
(14)
National reference laboratories assisting the CRL for the duties and tasks set out in the Annex to Regulation (EC) No 1829/2003 should be part of the European Network of GMO Laboratories (ENGL), whose members represent the state-of-the-art in GMO detection, including expertise in method development, performance and validation, sampling and management of biological and analytical uncertainties. They should also meet specific requirements where they have to assist the CRL specifically for testing and validation of detection methods in the context of collaborative studies according to international standards.
(15)
In the interests of stability and efficacy and in order to make the validation procedure operational in accordance with this Regulation, it is necessary to designate the national reference laboratories apt to assist the CRL for testing and validation of detection methods.
(16)
The relationship between the national reference laboratories assisting the CRL for testing and validation of detection methods and between them and the CRL should be defined by a written agreement.
(17)
The Annex to Regulation (EC) No 1829/2003 should be amended accordingly.
(18)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter and scope
This Regulation lays down detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 as regards:
(a)
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 said Regulation; and
(b)
the establishment of national reference laboratories.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(a)
‘full validation procedure’ means the assessment through a ring trial involving national reference laboratories of the method performance criteria set by the applicant as compliant with the document entitled ‘Definition of minimum performance requirements for analytical methods of GMO testing’ referred to in point 1(B) of Annex I to Regulation (EC) No 641/2004, and the assessment of the repeatability and trueness of the method provided by the applicant;
(b)
‘small and medium-sized enterprise (SME)’ means small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC (4);
(c)
‘developing countries’ means beneficiary countries as referred to in Article 2 of Council Regulation (EC) No 980/2005 of 27 June 2005 applying a scheme of generalised tariff preferences (5);
(d)
‘application’ where used without further specification, means an application for authorisation submitted in accordance with Article 5 or 17 of Regulation (EC) No 1829/2003, including applications submitted under other Community legislation which are transformed or supplemented in accordance with Article 46 of that Regulation. It also refers to applications for renewal of authorisations according to Article 11 or 23 of Regulation (EC) No 1829/2003 and modifications of authorisations according to Articles 9(2), 10, 21(2) or 22 of that Regulation, where the CRL is requested to test and validate a method of detection and identification.
Article 3
Contributions
1. For each application, a flat-rate contribution of EUR 30 000 shall be paid by the applicant to the CRL.
2. 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 (EC) No 641/2004 is required, the CRL shall request the applicant to pay an additional contribution of EUR 60 000.
This amount shall be multiplied by the number of GMO events to be fully validated.
The CRL shall reduce the amount of the additional contribution, in proportion of the costs saved:
(a)
where the material needed to perform the full validation procedure is supplied by the applicant; and/or
(b)
where the applicant provides data that refer to modules, such as DNA extraction protocols and species specific reference systems, already validated and published by the CRL.
3. Where the costs of the validation of the detection method proposed by the applicant exceed substantially the amount of the financial contributions mentioned under paragraphs 1 and 2, an additional contribution shall be requested.
The additional contribution shall cover 50 % of the part of the costs exceeding the amount of the contributions referred to in paragraphs 1 and 2.
4. The contributions provided for in paragraphs 1 and 2 remain due in case of withdrawal of the application.
Article 4
Reductions and exemptions
1. Where the applicant is a SME or has its head office established in a developing country, the financial contributions referred to in Article 3(1) and (2) shall be reduced by 50 %.
2. Where the same method of detection and identification has already been included in a previous application by the same applicant for products related to the same GMO and that method has been validated and published by the CRL or its validation is pending, that applicant shall be exempted from the payment of the financial contributions referred to Article 3.
However, where costs are incurred by the CRL in carrying out the validation tasks laid down in Regulation (EC) No 1829/2003, the CRL may charge the applicant a maximum contribution of EUR 30 000.
3. Article 3(3) shall not apply where the applicant is a SME or has its head office established in a developing country, nor to applications submitted before the entry into force of this Regulation.
Article 5
Procedure
1. The applicant shall provide evidence that the flat-rate contribution of EUR 30 000 referred to in Article 3(1) has been paid to the CRL when it submits the samples of the food and feed and their control samples to the CRL in accordance with Article 5(3)(j) or Article 17(3)(j) of Regulation (EC) No 1829/2003.
2. Where, as provided for in Article 3(2), a full validation procedure is required, the CRL shall notify the applicant in writing of this fact and require the payment of the amount due in accordance with that provision.
3. Where, as provided for in Article 3(3), the CRL expects the costs of the validation of the detection method proposed by the applicant to exceed substantially the amount of the financial contributions referred to in Article 3(1) and (2), it shall notify the applicant in writing of the estimated amount of the additional costs.
If, within one month of the date of receipt of the notification, the applicant withdraws its application, the additional contribution referred to in Article 3(3) is not due.
After completion of the validation of the detection method, the CRL shall notify the applicant in writing the actual and duly justified costs incurred in carrying out the validation of the detection method and require payment of the contribution due in accordance with Article 3(3).
4. Where, as provided for in Article 4(2), costs are incurred, the CRL shall notify the applicant in writing of the amount of the contribution due, including a justification of that amount.
5. Where an application has been submitted before the date of entry into force of this Regulation, the CRL shall, within three months of that date, notify in writing the applicant of the amount of the financial contribution to be paid according to Article 3(1) and (2) as appropriate.
6. When a reduction of the contribution is claimed in accordance with Article 4(1), the application shall be accompanied by written evidence that the conditions laid down in that Article are fulfilled. The CRL may require supplementary information where appropriate.
7. The contributions mentioned in paragraph 2 to 5 shall be payable by the applicant within 45 days of the date of reception of the notification.
Where the applicant has not provided proof of payment within the set time limit, and where the evaluation report referred to in point 3(e), of the Annex to Regulation (EC) No 1829/2003 has not yet been sent to the European Food Safety Authority (the Authority), the CRL shall not submit it to the Authority until the reception of the due payment. The CRL shall immediately notify the Authority that its report will be delayed, to enable the Authority to inform the applicant and take any further steps required under Articles 6(1) to (2) and 18(1) to (2) of Regulation (EC) No 1829/2003.
Article 6
National reference laboratories assisting the CRL for testing and validating the methods of detection and identification
1. Laboratories which assist the CRL in testing and validating the method of detection and identification, as provided for in Articles 6(3)(d) and 18(3)(d) of Regulation (EC) No 1829/2003, shall fulfil the minimum requirements laid down in Annex I to this Regulation.
The laboratories listed in Annex II, are meeting those requirements, and are hereby appointed as national reference laboratories under Regulation (EC) No 1829/2003 to assist the CRL for testing and validating the method of detection.
2. The CRL and the national reference laboratories listed in Annex II shall enter into a written agreement to define the relations between them, notably in financial matters. In particular, the written agreement shall provide that the CRL is to distribute a share of the financial contributions it receives to the national reference laboratories.
Article 7
Reporting
The CRL shall be responsible for preparing an annual report on each year’s activities carried out for the implementation of this Regulation and shall submit it to the Commission. The national reference laboratories under Regulation (EC) No 1829/2003 shall contribute to this annual report.
The CRL may also organise an annual meeting with the national reference laboratories, in view of the establishment of the annual report.
Article 8
Amendment to Regulation (EC) No 1829/2003
The Annex to Regulation (EC) No 1829/2003 is amended in accordance with Annex III to this Regulation.
Article 9
Entry into force
This Regulation shall enter into force on the 20th day following 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, 22 December 2006.