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subseccion EnlacesTechnological ingredients

Transformation of food in the food industry requires the use of a series of ingredients with a technological function, without which many of the foodstuffs on the market today could not be sold. These ingredients are technological processing aids and additives, aromas and food enzymes.

A packet of EU Regulations on "agents to improve food" i.e. additives, aromas and food enzymes, and the common procedure for authorisation, has recently been published in the Official Journal (31/12/2008). [More Info]

Legislation

PROCEDURE FOR THE PREPARATION OF REQUESTS FOR AUTHORISATION FOR ADDITIVES, ENZYMES AND FOOD FLAVOURINGS

The basis of the authorisation procedure is that, either the European Commission, or a Member State of the European Union or any of the interested parties, may initiate an application for authorisation for food additives, food enzymes or food flavourings. 

The application for authorisation may always be directed at updating the existing lists of the above-mentioned substances, in the following manner:

  • Add a new substance to existing lists.
  • Delete a substance already on the list in view of new data.
  • Modify the existing conditions for a previously authorised substance.

What is the usual procedure followed by an application? :

  1. Applicants must send applications to the European Commission.
  2. Depending on the use requested for the substance, the European Commission may ask the European Food Safety Authority (EFSA) to perform a risk assessment with consideration of the data submitted by the applicant. EFSA has a deadline for submitting their opinion on the safety of the requested use of nine months from the receipt of the application for its assessment. 
  3. The European Commission, after assessing the application, sends a draft proposal for its inclusion/removal/modification in the lists of the Standing Committee on the Food Chain.  
  4. The proposal sent by the European Commission will be put to vote; for acceptance or rejection, using the scrutiny procedure as laid out in article 5 of Decision 1999/468/EC.  

What information must be included in the application sent to the Commission? :

  • Administrative data  
  • General and specific data about the substance for risk assessment.
  • Data for risk management.

Where can I find detailed information about the authorisation procedure?

All the necessary requirements and detailed information for the correct preparation of an application for the inclusion of a new food additive, enzyme or flavouring, or a new use of the same, can be found in Regulation (EU) No 234/2011 and in the Practical guidance for applicants written by the European Commission.

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