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Home Resources Legal Updates March 2019
The Food for Specific Groups (Information and Compositional Requirements Amendment) Regulations 2019

The Food for Specific Groups (Information and Compositional Requirements Amendment) Regulations 2019

01 March 2019

Came into effect: 22nd February 2019.

These Regulations provide for the enforcement in Wales, of:

  • Regulation (EU) No. 2016/128, supplementing Regulation (EU) No. 609/2013, on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control which sets out the general rules for governing the composition and labelling requirements for certain categories of food; and
  • Regulation (EU) No. 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control which sets out specific information and compositional requirements for Food for Special Medical Purposes (FSMP).

These Regulations provide for implementation by applying certain provisions of the Food Safety Act 1990.

These Regulations implement the following Articles of Regulations (EU) No. 2016/128:

  • Article 2(2) (requirement for the formulation of food to be based on sound medical and nutritional principles)
  • Article 3(2) (requirement relating to residue levels)
  • Article 3(4) (prohibition on the use of plant protection products)
  • Article 5(2) (specific requirements on food information)
  • Article 6 (specific requirements on food information)
  • Article 7 (nutrition and health claims)
  • Article 9 (notification requirement)


They also make amendments to The Food for Specific Groups (Information and Compositional Requirements) (Wales) Regulations 2016 in Regulation 2 and 7.

Regulation 2 (interpretation) includes a definition of ‘Delegated regulation’ to mean Regulation (EU) No. 2016/128 as well as a definition of ‘food for special medical purposes’ which is to have the same meaning as in Regulation (EU) No. 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control , Article 2(g), to ensure consistency. The term ‘infant’ is a child under 12 months. The definition of ‘Specified EU requirement’ includes reference to the Delegated Regulation (Regulation (EU) No. 2016/128) and Paragraph 6 is added to clarify that this regulation does not cover FSMP for infants.

Regulation 7, (Transitional arrangements) is added to introduce a transitional arrangement which allows for stocks of foods not complying with Regulation (EU) No.2016/128 to be marketed until stocks are exhausted under certain conditions.

Amendments are also made to The Medical Food (Wales) Regulations 2000 in Regulation 2 (interpretation). They make it clear that the regulation is only for Food for Special Medical Purposes (FSMP) for infants.

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