The Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (England) Regulations 2024

Regulation 6(2)(b)

SCHEDULE 4Substitution of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for Bovine milk basic whey protein isolate

This schedule has no associated Explanatory Memorandum
Bovine milk basic whey protein isolate

Specified food category

Infant formula as defined in Regulation (EU) No. 609/2013(1)

Follow-on formula as defined in Regulation (EU) No. 609/2013

Total diet replacement for weight control as defined in Regulation (EU) No. 609/2013

Foods for special medical purposes as defined in Regulation (EU) No. 609/2013

Food supplements as defined in the Food Supplements (England) Regulations 2003

Maximum levels

30 mg/ 100g (powder

3.9 mg/100 ml (reconstituted)

30 mg/ 100 g (powder)

4.2 mg/100 ml (reconstituted)

300 mg/day

30 mg/100 g (powder formula for infants (persons under the age of 1 year (12 months)) during first months of life until the introduction of appropriate complementary feeding)

3.9 mg/100 ml (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding)

30 mg/100 g (powder formula for

infants when appropriate complementary feeding is introduced)

4.2 mg/100 ml (reconstituted formula for infants when appropriate complementary feeding is introduced)

58 mg/day for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months))

380 mg/day for children and adolescents (aged 3 years (36 months) to 18 years of age)

610 mg/day for persons aged 18 years or above

25 mg/day for infants (persons under the age of 1 year (12 months))

58 mg/day for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months))

250 mg/day for children and adolescents (aged 3 years (36 months) to 18 years of age)

610 mg/day for persons aged 18 years or above

The designation of the novel food on the labelling of food containing it is “Milk whey protein isolate”.

The labelling of food supplements must bear a statement, as appropriate, that they should not be consumed by infants (persons under the age of 1 year)/infants or young children (persons under the age of 3 years)/infants, children or adolescents (persons under the age of 18 years).

(1)

EUR 2015/2283, amended by S.I. 2019/702; there are other amending instruments but none is relevant. The terms “prescribe”, “appropriate authority”, and “list” are defined in Article 3. Article 12(1) applies in accordance with Articles 9 and 27(1).