The Food for Specific Groups (Information and Compositional Requirements (Amendment) (England) Regulations 2019
Jurisdiction: England
Commencement: 22nd February 2019
Amends:
The Food for Specific Groups (Information and Compositional Requirements (England) Regulations 2016
Medical Food (England) Regulations 2000
Mini Summary
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; 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
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 Regulation (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)
Which requires the formulation of FSMP to be based on sound medical and nutritional principles, used in accordance within the manufacturers instructions and meeting the specific nutritional requirements for who it is intended for.
Article 3(2) (requirement relating to residue levels insofar as it applies to young children rather than infants)
FSMPs to satisfy the nutritional requirements of infants and young children shall not contain residue levels exceeding 0.01 mg/kg per active substance.
Article 3(4) (prohibition on the use of plant protection products insofar as it applies to young children rather than infants)
FSMPs shall only be produced from agricultural products for the production, if the active substances listed in Annex III have not been used.
Article 4 (name of the food)
The name of a FSMP shall be as set out in accordance with Annex IV
Article 5(2) (specific requirements on food information)
This lists the statements that must be included on the labels of FSMP
Article 6 (specific requirements on food information)
Declaring the nutritional information is mandatory for all FSMP 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 competent authority where the product is being marketed and is to send a label containing the all the information appearing on the product.
Amendments
Food for Specific Groups (Information and Compositional Requirements) England Regulations 2016
These Regulations make provision to enforce 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.
This is first Regulation that sets out the specific information and compositional requirements for FSMP.
In Regulation 2 (interpretation), paragraph 1,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 inserted to have the same meaning as in Regulation (EU) No. 609/2013, 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, the Regulation (EU) No. 2016/128 only applies in so far as it applies to FSMP and not FSMP to satisfy the nutritional requirements of infants.
Regulation 8, (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 the Regulation (EU) No. 609/2013;
- were placed on the market or labelled before 22nd February 2019; and
- meet requirements of regulation 3(1), and (2) of the Medical Food (England) Regulations 2000, which restricts the sale of medical foods unless the requirements of Directive 1999/21/EC are complied with.
A new table is inserted into Schedule 1 to ensure consistency with the provision of the EU Regulations. References to the Regulation (EU) No. 2016/128 in Schedule 1 should be read as the most up to date version as amended. [February 2019]
The Medical Food (England) Regulations 2000
An amendment is made 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) (England) Regulations 2016.
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