CHAPTER XV

INFORMATION AND COMMUNICATION
SECTION 1

Monitoring and reporting

Compliance with requirements
Article 65
1
The competent authority shall make the necessary arrangements for the monitoring of biocidal products and treated articles which have been placed on the market to establish whether they comply with the requirements of this Regulation. Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products shall apply accordingly.
2
The competent authority shall make the necessary arrangements for official controls to be carried out in order to enforce compliance with this Regulation.
In order to facilitate such enforcement, manufacturers of biocidal products placed on the market in Great Britain shall maintain, in relation to the manufacturing process, appropriate documentation in paper or electronic format relevant for the quality and safety of the biocidal product to be placed on the market and shall store production batch samples. The documentation shall include as a minimum:
a
safety data sheets and specifications of active substances and other ingredients used for manufacturing the biocidal product;
b
records of the various manufacturing operations performed;
c
results of internal quality controls;
d
identification of production batches.
...
Measures taken pursuant to this paragraph shall avoid causing disproportionate administrative burden to economic operators and the competent authority.
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OJ L 218, 13.8.2008, p. 30.
Words in Art. 65(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 111(2); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 65(2) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 111(3)(b) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 31)
Words in Art. 65(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 111(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 65(2) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 111(3)(c); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 65(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 111(3)(d); 2020 c. 1, Sch. 5 para. 1(1)
Art. 65(3) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 111(4); 2020 c. 1, Sch. 5 para. 1(1)
Art. 65(4) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 111(5); 2020 c. 1, Sch. 5 para. 1(1)