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Regulation (EC) No 470/2009 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (Text with EEA relevance)

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Article 19Methods for establishing reference points for action

1.The reference points for action to be established pursuant to Article 18 shall be based on the content of an analyte in a sample, which can be detected and confirmed by official control laboratories designated in accordance with Regulation (EC) No 882/2004 with an analytical method validated in accordance with Community requirements. The reference point for action should take into account the lowest residue concentration which can be quantified with an analytical method validated in accordance with Community requirements. The Commission shall be advised on the performance of analytical methods by the relevant Community reference laboratory.

2.Without prejudice to the second subparagraph of Article 29(1) of Regulation (EC) No 178/2002, the Commission shall, where appropriate, submit a request to EFSA for a risk assessment as to whether the reference points for action are adequate to protect human health. In those cases, EFSA shall ensure that the opinion is given to the Commission within 210 days of receipt of the request.

3.The principles of risk assessment shall be applied in order to guarantee a high level of protection of health. The risk assessment shall be based on methodological principles as well as scientific methods to be adopted by the Commission in consultation with EFSA.

Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 26(3).

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