Centre d'assistance sur les dossiers d’évaluation

We have published updated guidance documents to reflect the new provisions of the Transparency Regulation.
You can find them in the 'regulations and guidance' section of each regulated product area.

Just published:

• Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances and on the maximum residue level (MRL) application procedure
• Administrative guidance for the preparation of applications on smoke flavouring primary products
• Administrative guidance for the preparation of applications on novel foods pursuant to Article 10 of Regulation (EU) 2015/2283
• Administrative guidance for the preparation of applications on additives for use in animal nutrition 
• Administrative guidance for the preparation of applications on recycling processes to produce recycled plastics intended to be used for manufacture of materials and articles in contact with food
• Administrative guidance for the preparation of applications on substances to be used in active and intelligent materials and articles intended to come into contact with food
• Administrative guidance for the preparation of applications on food improvement agents (food enzymes, food additives and food flavourings)
• Administrative guidance for the preparation of applications on substances to be used in plastic food contact materials
• Administrative guidance for the preparation of applications on genetically modified plants
• Administrative guidance for the preparation of renewal applications on genetically modified food and feed
• Guidance on the preparation and presentation of applications for exemption from mandatory labelling of food allergens and/or products thereof pursuant to Article 21 (2) of Regulation (EU) No 1169/2011
• Scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013
• General scientific guidance for stakeholders on health claim applications (Revision 1)
• Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3)
• Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/22831 (Revision 1)
• Guidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 (Revision 1)
• Scientific and technical guidance for the preparation and presentation of a dossier for evaluation of an infant and/or follow‐on formula manufactured from protein hydrolysates (Revision 1)

• Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources (Revision 1) (update 2021)