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DG SANCO.D.4 Health and Consumer Protection Sector: Biotechnology Kim-Helleberg MADSEN

DG SANCO.D.4 Health and Consumer Protection Sector: Biotechnology Kim-Helleberg MADSEN. Regulation (EC) No 258/97 concerning Novel Foods and Novel Food Ingredients - Application Procedure. Application made in the Member State in which the product is to be

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DG SANCO.D.4 Health and Consumer Protection Sector: Biotechnology Kim-Helleberg MADSEN

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  1. DG SANCO.D.4 Health and Consumer Protection Sector: Biotechnology Kim-Helleberg MADSEN

  2. Regulation (EC) No 258/97 concerning Novel Foods and Novel Food Ingredients - Application Procedure Application made in the Member State in which the product is to be placed on the market for the first time (Article 4.1) Initial assessment carried out by Member State’s competent authority within 3 months of application (Article 4.2, Article 6). Initial assessment decides whether or not additional assessment is required. Initial assessment forwarded to Member States via the Commission. 60 days for Member States or Commission to make comments or present a reasoned objection. (Article 6.4 ) No objections: result. Objections (or additional assessment required): authorization decision required (Article 7).

  3. Novel Food Application Procedure cont. No objections: result Objections (or additional assessment required): authorization decision required (Article 7). Member State informs applicant whether or not the food or food ingredient may be placed on the market (Article 6.4) If objections relate to public health, and/or are of a technical/ safety matter the Scientific Comm is consulted. (Article 11). Information should be published in the Official Journal of the European Communities. Commission submits a draft of the measures to be taken and the Scientific Committee delivers its opinion (Article 13).

  4. Reg (EC) N° 1829/2003 on GM food and feed – Application Procedure Application shall be submitted to a competent authority of a Member State (Articles 5 (2), 17 (2)) Member State forwards application to EFSA Articles 5 (2) (iii), 17 (2) (iii) EFSA carries out the risk assessment – deadline 6 months. Articles 6-18 For GMOs for food/feed use, EFSA may ask a competent authority of a Member State For GMOs for cultivation, EFSA shall ask a competent authority to carry out a risk assessment

  5. GM food and feed Application Procedure cont. For GMOs for food/feed use, may ask a competent authority of a Member State For GMOs for cultivation, shall ask a competent authority to carry out a risk assessment EFSA forwards its conclusion to the Commission, Member States and the applicant – Articles 6 (6), 18 (6) Commission drafts a decision to be presented to the Member States in the Standing Committee (Article 7) Article 19

  6. Novel Foods GM food/feed • Pre-market safety assessment Yes Yes • Simplified procedure for substantial Yes No equivalence • Timespan of authorisations Unlimited Max 10 years • Provision and detection methods, No Yes and validation • Public consultation No Yes

  7. Novel Food GM food/feed • Public access to documents “No” Yes • Publication of the scientific assessment Yes Yes • “Centralised” authorisation procedure No Yes • Community Reference Laboratory No Yes on GM food and feed • Consultation on ethicsNo Yes

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