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

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

07 February 2019

These Regulations provide for the enforcement in England, 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).

It enforces the following Articles of Regulation (EU) No. 2016/128:

  • Article 2(2) on the requirement for the formulation of food to be based on sound medical and nutritional principles.
  • Article 3(2) on the requirement relating to residue levels insofar as it applies to young children rather than infants.
  • Article 3(4) in relation to the prohibition on the use of plant protection products insofar as it applies to young children rather than infants.
  • Article 4 in relation to the name of the food
  • Article 5(2) in relation to specific requirements on food information.
  • Article 6 in relation to specific requirements on food information.
  • Article 7 in relation to nutrition and health claims.
  • Article 9 in relation to notification requirement.


The regulation also amends the following legislation:

Amendments to Food for Specific Groups (Information and Compositional Requirements) England Regulations 2016. Provisions are made to enforce Regulation (EU) No. 2016/128, supplementing Regulation (EU) No. 609/2013. This is the first Regulation that sets out the specific information and compositional requirements for food for special medical purposes (FSMP).  FSMP are foods that are designed to feed patients who, because of a particular disease, disorder or medical condition, have nutritional needs that cannot be met by consuming standard foodstuffs.

Several insertions have been made in Regulation 2 to include references for Regulation (EU) No. 609/2013 and Regulation (EU) No. 2016/128.

Regulation 8 is inserted 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.

Amendments to The Medical Food (England) Regulations 2000
An amendment is made to make it clear that this regulation only covers Food for Special Medical Purposes for infants by including the phrase ‘developed to satisfy the nutritional requirements of infants’ into the definition of medical food.

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