The Food for Specific Groups (Information and Compositional Requirements Amendment) (Wales) Regulations 2019
Jurisdiction: Wales
Commencement: 22nd February 2019
Amends:
1. The Food for Specific Groups (Information and Compositional requirements) (Amendment) (Wales) Regulations 2016
2. The Medical Food (Wales) Regulations 2000
Mini Summary
These Regulations provide for the enforcement of:
- Regulation (EU) No. 2016/128, supplementing Regulations (EU) No. 609/2013 as regards the specific compositional and information requirements for food for special medical purposes; 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.
Food for Special Medical Purposes (FSMP) is a category of food for particular nutritional uses that have been specially processed or formulated and are intended for the dietary management of patients and to be used under medical supervision.
Regulation (EU) No. 2016/128 is the first Regulation that sets out the specific information and compositional requirements for Food for Special Medical Purposes (FSMP)
Regulation (EU) No. 609/2013 sets out the general rules for governing the composition and labelling requirements for certain categories of food.
These Regulations provide for the enforcement of those requirements by applying certain provisions of the Food Safety Act 1990
Duties
These Regulations enforce the following Articles of Regulations (EU) No. 2016/128 and their requirements:
Article 2(2) (requirement for the formulation of food to be based on sound medical and nutritional principles)
Requires the formulation of FSMP to be based on sound medical and nutritional principles, used in accordance in the manufacturers instructions and meeting the specific nutritional requirements for who it is intended for.
Article 3(2) (requirement relating to residue levels)
FSMPs designed to satisfy the nutritional requirements of young children shall not contain residue levels exceeding 0.01 mg/kg per active substance. Active substances are referred to micro-organisms having general or specific action against harmful organisms.
Article 3(4) (prohibition on the use of plant protection products)
FSMP designed to satisfy the nutritional requirements of young children shall not contain any agricultural products which have been produced using plant protection products (pesticides etc.) which contain any of the active substances listed in Annex III.
Article 5(2) (specific requirements on food information)
This lists the statements that must be included on the labels of FSMPs
Article 6 (specific requirements on food information)
Declaring the nutritional information is mandatory for all FSMPs irrespective of the size of the container or packaging it is placed in.
Article 7 (nutrition and health claims)
There shall be no nutrition and health claims on FSMPs
Article 9 (notification requirement)
When a FSMP is placed on the market, the food business operator must notify the food authorities in Wales where the product is being marketed and is to send them a label containing all the information appearing on the product.
The Food for Specific Groups (Information and Compositional Requirements) (Wales) Regulations 2016
These Regulations enforce Regulation (EU) No. 2016/128 supplementing Regulation (EU) No 609/2013 as regards the specific compositional and information requirements for food for special medical purposes (FSMP).
This is the first Regulation that sets out the specific information and compositional requirements for FSMP.
Regulation 2 (interpretation) the following amendments are made:
- A definition of €˜Delegated Regulation is inserted to mean Regulation (EU) No. 2016/128
- A definition of €˜food for special medical purposes is added 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 has been defined as a child under the age of 12 months.
- The definition of €˜Specified EU requirement now includes reference to the Delegated Regulation (Regulation (EU) No. 2016/128).
- Paragraph 6 is inserted to make clear that; as this regulation does not cover FSMP for infants, Regulation (EU) No. 2016/128 only applies to FSMP and not FSMP to satisfy the nutritional requirements of infants.
Regulation 7, (Transitional arrangements) 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 as long as they;
- comply with the specified provisions of Regulation (EU) No. 609/2013;
- Were placed on the market or labelled before 22nd February 2019; and
- meets the requirements of Regulation 3 of the Medical Food (Wales) Regulations 2000, which restricts the sale of medical foods unless the requirements of Directive 1999/21/EC on dietary foods for special medical purposes are complied with.
A new table is inserted into Schedule 1 to ensure consistency with the provision of the EU Regulations. References to Regulation (EU) No. 2016/128 in Schedule 1 should be read as the most up to date version as amended.
The Medical Food (Wales) Regulations 2000
An amendment is made to Regulation 2 (interpretation) to make clear that this Regulation only covers Food for Special Medical Purposes (FSMP) for infants by including the phrase €˜developed to satisfy the nutritional requirements of infants, into the definition of medical food.
Other FSMPs are covered by The Food for Specific Groups (Information and Compositional Requirements) (Wales) Regulations 2016
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