EU Regulatory Compliance Consulting
Comprehensive regulatory compliance services for the food, animal feeds, and other ingredients for the EU market.
Applicable Objects
This requirement applies to food ingredients used in general foods, food supplements, infant foods, or foods for special medical purposes marketed in the EU that were not consumed to a significant degree within the EU before May 15, 1997.
Compliance Pathway Overview
A Novel Food application must be submitted to the European Food Safety Authority (EFSA). If EFSA issues a positive scientific opinion, the European Commission authorizes the ingredient and includes it in the Union List of Novel Foods under Regulation (EU) 2017/2470.
Our Services
- Feasibility Assessment
- PRE-ID Application and NOS Submission
- Dossier Preparation
- GMP/HACCP System Development
- Toxicological Testing Assistance and Design
- EFSA Inquiry and Supplementary Response
Applicable Objects
Applicable to food additive ingredients with specific technical functions used in foods sold in the EU market.
Compliance Pathway Overview
A Food Additive application must be submitted to the European Food Safety Authority (EFSA). If EFSA issues a positive scientific opinion, the European Commission authorizes the additive and includes it in the Union List of Food Additives under Regulation (EC) No 1333/2008 (Annex II/III), in compliance with Regulation (EU) No 231/2012.
Our Services
- Feasibility Assessment
- PRE-ID Application and NOS Submission
- Dossier Preparation
- GMP/HACCP System Development
- Toxicological Testing Assistance and Design
- EFSA Inquiry and Supplementary Response
Applicable Objects
Applicable to food enzyme ingredients used in EU food processing.
Compliance Pathway Overview
A Food Enzyme application must be submitted to the European Food Safety Authority (EFSA). If EFSA issues a positive scientific opinion, the European Commission authorizes the enzyme and includes it in the Union List of Food Enzymes under Regulation (EC) No 1332/2008.
Our Services
- Feasibility Assessment
- PRE-ID Application and NOS Submission
- Dossier Preparation
- GMP/HACCP System Development
- Toxicological Testing Assistance and Design
- EFSA Inquiry and Supplementary Response
Applicable Objects
Applicable to flavouring ingredients used in foods sold in the EU market
Compliance Pathway Overview
A Food Flavourings application must be submitted to the European Food Safety Authority (EFSA). If EFSA issues a positive scientific opinion, the European Commission authorizes the flavouring and includes it in the Union List of Flavourings and Source Materials under Regulation (EU) No 872/2012.
Our Services
- Feasibility Assessment
- PRE-ID Application and NOS Submission
- Dossier Preparation
- GMP/HACCP System Development
- Toxicological Testing Assistance and Design
- EFSA Inquiry and Supplementary Response
Applicable Objects
Applicable to new feed ingredients or feed additives used in pet foods, livestock and poultry feeds, and aquaculture feeds sold in the EU market
Compliance Pathway Overview
A Feed Additive application must be submitted to the European Food Safety Authority (EFSA). If EFSA issues a positive scientific opinion, the European Commission authorizes the additive and includes it in the Union Register of Feed Additives under Regulation (EC) No 1831/2003.
Our Services
- EU Agent Services
- Feasibility Assessment
- PRE-ID Application and NOS Submission
- Dossier Preparation
- GMP/HACCP System Development
- Toxicological Testing Assistance and Design
- Feeding Trial Assistance and Design
- EFSA Inquiry and Supplementary Response