EU Food Additive Authorization Application

What is a food additive in the EU?

As defined in the Regulation (EC) No 1333/2008, food additive shall mean any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods.

Differing from China, which regulates the nutrient fortifiers, food enzymes (enzyme preparations), and food flavorings under food additives, the EU has established separate regulatory frameworks for them:

• Nutrients: Regulation (EC) No 1925/2006;
• Food enzymes: Regulation (EC) No 1332/2008; and
• Food flavorings: Regulation (EC) No 1334/2008

Why apply for a food additive?

The EU established the Community list as a “positive list” for food additives. According to Article 4 of the Regulation (EC) No 1333/2008, only food additives included in the Community list may be placed on the market as such and used in foods under the conditions of use specified therein. The list is updated based on the approval status of substances.

Who can be the applicant?

As regulated in Regulation (EC) No 1331/2008 on common authorisation procedure for food additives, food enzymes and food flavourings, applications may be made by a Member State or by an interested party, who may represent several interested parties, in accordance with the conditions provided for by the implementing measures.

Authorisation procedure

Applications for authorisation are submitted to the European Commission and evaluated by the European Food Safety Authority (EFSA). The procedures are as follows:

Pre-submission phase:

• Potential applicant requests general pre-submission advice (optional)
• Potential applicant notifies studies commissioned or carried out as of 27 March 2021

Submission phase & completeness check

• Applicant submits application via e-submission system to the EC
• The EC tasks EFSA and makes the application available to EFSA
• Receipt of the application by EFSA and suitability check (30 working days)
• EFSA declares the application suitable

Risk assessment phase (9 months + Request of additional information)

• EC validates the application
• EFSA launches public consultation on the application dossier
• EFSA performs a thorough risk assessment
• EFSA Panel adopts the scientific output

Post-adoption phase

• EFSA publishes the scientific output
• Based on EFSA’s opinion, the EC prepares a draft regulation

Materials required for the application

As regulated in Regulation (EU) No 234/2011 on implementing Regulation (EC) No 1331/2008 (common authorisation procedure for food additives, food enzymes and food flavourings), the information on the specific requirements for application dossiers are summarized below.

Administrative data

• Applicant’s contact details;
• Manufacturer(s)’s contact details, if different than the applicant’s;
• Contact details of the person responsible for the dossier;
• Basic information on the food additive

Data required for risk assessment 

1. The identity and characterisation of the additive, including the proposed specifications and analytical data;
2. Where applicable, the particle size, particle size distribution and other physicochemical characteristics;
3. The manufacturing process;
4. Presence of impurities;
5. The stability, reaction and fate in foods to which the additive is added;
6. The proposed normal and maximum use levels in the food categories;
7. A dietary exposure assessment;
8. The biological and toxicological data: subchronic toxicity and genotoxicity should be covered.

Data required for risk management

1. The identity of the food additive, including reference to the existing specifications;
2. the function and technological need for the level proposed in each of the food categories or products;
3. The efficacy of the food additive for the intended effect at the use level proposed;
4. Advantages and benefit for the consumer.
5. Why the use would not mislead the consumer;
6. The proposed normal and maximum use levels in the food categories;
7. The dietary exposure assessment;
8. The amount of the food additive present in the final food as consumed by the consumer;
9. Analytical methods allowing the identification and quantification of the additive or its residues in food.

CIRS services

• EU food additive authorization application feasibility analysis;
• EU food additive authorization application service; and
• Other customized compliance services

About Us

The Food Business Division of CIRS Group, established in 2012, has successfully assisted over 1,000 domestic and international food and feed companies in achieving "one-stop" regulatory compliance. Leveraging our extensive expertise and resources across multiple jurisdictions, we provide comprehensive compliance solutions including:

• China - “Three New” Food Registration: new food material, new food additives, and new food contact materials (including synthetic biology-derived products)
• China - New Feed and New Feed Additive Application
• US - FDA GRAS Notice
• US - Animal Food GRAS Conclusions
• EU - Novel Food Application
• EU - Food Enzyme (Food Enzyme Preparation) Application
• EU - Food Additive Application
• EU - Feed Additive Application

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.