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Parliamentary questions
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11 June 2019
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-001942/2019

Phenylketonuria (PKU) is an inborn error of metabolism that results in decreased metabolism of the amino acid phenylalanine. Treatment is with a diet low in protein, as most foods containing protein contain phenylalanine. When needed, diets may be supplemented by special formulas for people with PKU to provide essential nutrients that would otherwise be lacking in their diet.

Regulation (EU) No 1169/2011 on the provision of food information to consumers(1) requires the indication of the amount of protein as part of the mandatory nutrition declaration, thereby informing if a food is high or low in protein. If the sweetener aspartame is used in a food, the regulation requires specific information on the labelling that aspartame is ‘a source of phenylalanine’.

Special formulas for people with PKU are covered by Regulation (EU) 2016/128 laying down specific compositional and information requirements for food for special medical purposes (FSMP)(2), and must additionally be labelled in accordance with that regulation. In particular, pursuant to its Article 6(1)(b), the mandatory nutrition declaration shall include the amount of components of protein, including, inter alia, phenylalanine, present in the product to ensure that all information necessary for the appropriate use of the FSMP is labelled.

Both Regulations mentioned above apply to imported foods when placed on the EU market.

The Commission considers that the current rules are adequate and that further legislation in this area is not necessary.

(1)OJ L 304, 22.11.2011, p. 18-63.
(2)OJ L 25, 2.2.2016, p. 30-43.

Last updated: 13 June 2019Legal notice