1. Health and Consumer Protection Sector: Biotechnology
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. Pre-market safety assessment Yes Yes
Novel Foods GM food/feed
Pre-market safety assessment Yes Yes
Simplified procedure for substantial Yes No equivalence
Timespan of authorisations Unlimited Max years
Provision and detection methods, No Yes and validation
Public consultation No Yes

7. Public access to documents “No” Yes
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 ethics No Yes