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Division 2.1.4 Purity

United Kingdom

Original text. Later amendments are not shown.

The applicant shall identify and quantify chemical and microbial impurities, substances with toxic or other undesirable properties that are not intentionally added and do not contribute to the activity of additive. In addition, for fermentation products, the applicant shall confirm the absence of production organisms in the additive. The protocol used for the routine screening of production batches for contaminants and impurities shall be described.

All the data provided have to support the proposal for a specification of the additive.

Specific requirements depending on the production process, complying with F1F2assimilated law, are listed below.

  1. 2.1.4.1Additives whose authorisation is linked to a holder of authorisation
  2. 2.1.4.2Additives whose authorisation is not linked to a holder of authorisation

Annotations

Textual amendments

F1

Words in Annex 2 point 2.1.4 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 83(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F2

Word in Annex 2 s. 2 point 2.1.4 substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 11(c)(i)