Commission Regulation (EU) 2021/1916 of 3 November 2021 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3oxopropoxy)-2-methylquinoline-3-carboxylic acid in the Union list of flavourings (Text with EEA relevance)

• CELEX: Regulation (EU) 2021/1916
• Articles: 3

Article 1

Annex I, Part A to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

In Part A, Section 2, Table 1 of Annex I to Regulation (EC) No 1334/2008, the following entry concerning FL No 16.130 is inserted after entry 16.127:

‘16.130

4-Amino-5-(3-(isopropylamino)-2,2-dimethyl-3oxopropoxy)-2-methylquinoline-3-carboxylic acid

1359963-68-0

2204

At least 99 % minimum assay (IR NMR MS)

Note: Part A, Section 2, Note 1 of Annex I to Regulation (EC) No 1334/2008 does not apply to this substance.

Restrictions for use as a flavouring substance expressed as a sum of the carboxylic acid and the hemisulfate monohydrate salt, expressed as the acid:

In category 1.4. – not more than 10 mg/kg.

In category 1.6.3. – not more than 30 mg/kg.

In category 1.8. – not more than 30 mg/kg.

In categories 2.2.1. and 2.2.2. – not more than 30 mg/kg.

In category 3. – not more than 30 mg/kg.

In category 4.2.3. – not more than 10 mg/kg.

In category 4.2.4.1. – not more than 30 mg/kg.

In category 4.2.4.2. – not more than 10 mg/kg.

In categories 4.2.5.1., 4.2.5.2., 4.2.5.3. and 4.2.5.4. – not more than 30 mg/kg.

In categories 5.1. and 5.2. – not more than 30 mg/kg.

In category 5.3. – not more than 300 mg/kg.

In category 5.4. – not more than 30 mg/kg.

In category 6.3. – not more than 45 mg/kg.

In category 7.2. – not more than 15 mg/kg.

In categories 8.3.1, 8.3.2. and 8.3.3. – not more than 15 mg/kg.

In categories 8.3.4.1., 8.3.4.2. and 8.3.4.3. – not more than 15 mg/kg.

In category 11.2. – not more than 30 mg/kg.

In category 12.4. – not more than 30 mg/kg.

In category 12.5. – not more than 10 mg/l.

In categories 14.1.2., 14.1.3. and 14.1.4. – not more than 7 mg/l.

In categories 14.1.5.1. and 14.1.5.2. – not more than 7 mg/kg.

In category 14.2.1. – not more than 7 mg/l.

In categories 14.2.2. and 14.2.5. – not more than 10 mg/l.

In category 15.1. – not more than 30 mg/kg.

In category 16 (excluding products covered in categories 1, 3 and 5) – not more than 15 mg/kg.

EFSA’

4-Amino-5-(3-(isopropylamino)-2, 2-dimethyl-3-oxopropoxy)-2 methylquinoline-3-carboxylic acid hemisulfate monohydrate salt

1460210-04-1

2204.1

Synonym: 3-quinolinecarboxylic acid, 4-amino-5-[2,2-dimethyl-3-[(1-methylethyl)amino]-3-oxopropoxy]-2-methyl-, sulfate, hydrate (2:1:2).

At least 99 % minimum assay (HPLC).