CHAPTER IV U.K.GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS

Article 17 U.K.Making available on the market and use of biocidal products

1. Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation.

2. Applications for authorisation shall be made by, or on behalf of, the prospective authorisation holder [F1 to the competent authority].

F2 ...

F3 ...

3. An authorisation may be granted for a single biocidal product or a biocidal product family.

4. An authorisation shall be granted for a maximum period of 10 years.

5. Biocidal products shall be used in compliance with the terms and conditions of the authorisation stipulated in accordance with Article 22(1) and the labelling and packaging requirements laid down in Article 69.

Proper use shall involve the rational application of a combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products is limited to the minimum necessary and appropriate precautionary steps are taken.

[F4 The competent authority] shall take necessary measures to provide the public with appropriate information about the benefits and risks associated with biocidal products and ways of minimising their use.

6. The [F5 biocidal product family authorisation holder shall notify the competent authority] of each product within the biocidal product family at least 30 days before placing it on the market, except where a particular product is explicitly identified in the authorisation or the variation in composition concerns only pigments, perfumes and dyes within the permitted variations. The notification shall indicate the exact composition, trade name and suffix to the authorisation number. F6 ...

F7 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Words in Art. 17(2) inserted (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. 78(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 17(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. 78(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 17(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. 78(2)(c); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 17(5) 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. 78(3); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 17(6) 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. 78(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 17(6) 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. 78(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F7 Art. 17(7) 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. 78(5); 2020 c. 1, Sch. 5 para. 1(1)

[F8 Article 17A U.K. NI Product Market Access

1. Subject to paragraphs 5-8, a biocidal product is to be treated as if it was authorised by the competent authority under Article 30 or, where relevant, Article 26, under the same terms and conditions as the product is authorised or permitted in Northern Ireland where—

(a) each of the following conditions are met—

(i) the biocidal product—

(aa) is a qualifying Northern Ireland good, and

(bb) has a Relevant NI Permission at that time;

(ii) the authorisation holder or the person with a Relevant NI Permission (as the case may be) is established in Northern Ireland;

(iii) all the active substances in the biocidal product are entered in—

(aa) the list prepared pursuant to Article 8A (the GB List), or

(bb) the list prepared pursuant to Article 24A (the Simplified Active Substance List);

(iv) the person referred to in point (a)(ii) notifies the competent authority no later than 90 days in advance of making the biocidal product available on the market by submitting in full to the competent authority the information that the person submitted in their application under Regulation (EU) No 528/2012 as it has effect in EU law to the evaluating competent authority, reference Member State or Northern Ireland competent authority (as the case may be), for the Relevant NI Permission together with a copy of any relevant NI authorisation or permit;

(v) the competent authority takes no action pursuant to paragraph 2;

(b) if the person referred to in point (a)(ii) intends to make any changes to the product, that person notifies the competent authority no later than 90 days in advance of the date on which such changes will apply, with the information submitted to the reference Member State pursuant to Article 5 of Commission Implementing Regulation (EU) No 354/2013 as it has effect in EU law, or for administrative changes other than those referred to in the second subparagraph of Article 6(2) of that Regulation, that person notifies the competent authority within 12 months of making the change;

(c) if the person referred to in point (a)(ii) intends to renew the authorisation of the product in Northern Ireland, that person notifies the competent authority no later than 90 days in advance of the date of renewal by submitting in full the information that the person submitted to the reference Member State pursuant to Articles 31(1) or 45(1) of Regulation (EU) No 528/2012 as it has effect in EU law or, where relevant, Article 2 of Commission Delegated Regulation (EU) No 492/2014 as it has effect in EU law.

2. The competent authority may prohibit a biocidal product notified under paragraph 1 from being made available on the market in Great Britain where—

(a) such action can be justified on any of the following grounds—

(i) the protection of the environment,

(ii) public policy or security,

(iii) the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants,

(iv) the protection of national treasures possessing artistic, historic or archaeological value,

(v) the target organisms not being present in harmful quantities, or

(b) the competent authority considers that the biocidal product does not meet the criteria set out in Articles 19 or 25.

3. The competent authority may amend the terms and conditions under which a biocidal product may be made available on the market in Great Britain where—

(a) this can be justified on the grounds in paragraph 2(a), or

(b) the competent authority considers that the biocidal product does not meet the criteria set out in Articles 19 or 25.

4. Where the competent authority intends to take action under paragraphs 2 or 3, or identifies concerns as to whether the biocidal product meets the criteria in Articles 19 or 25, the competent authority—

(a) must inform the notifier, and

(b) may request additional information.

5. The period of 90 days referred to in paragraphs 1(a)(iv), (b) and (c) is suspended—

(a) where the competent authority takes action under paragraph 4(b), until the competent authority receives the additional information, and

(b) from the point when the competent authority receives the additional information, for a further period of 90 days to allow the competent authority to consider that additional information.

6. Where any information submitted to the competent authority under this Article includes one or more letters of access, the competent authority may reject the letter of access where it does not hold the relevant data.

7. Where the additional information has not been submitted to the competent authority within 90 days of a request under paragraph 4(b), the notification made under paragraph 1 is to be treated as withdrawn.

8. Where the competent authority has amended the terms and conditions under which a biocidal product may be made available on the market under paragraph 3, that product must not be made available and used in Great Britain other than under those amended terms and conditions.

9. Where a biocidal product has been treated as authorised due to meeting the requirements of paragraph 1 but ceases to satisfy those requirements—

(a) there is deemed to be a cancellation of the authorisation of that product by the competent authority, and

(b) the period of grace provided for in Article 52 applies.

10. For the purposes of this Article—

(a) “NI competent authority” means the competent authority appointed by regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013;

(b) “qualifying Northern Ireland good” has the meaning given by regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

(c) “Relevant NI Permission” means any of the following—

(i) a national authorisation granted by the NI competent authority under Article 30 of Regulation (EU) No 528/2012 as it has effect in EU law or under Article 5 of Regulation (EU) No 414/2013 as it has effect in EU law;

(ii) an authorisation granted by mutual recognition by the NI competent authority under Articles 33 or 34 of Regulation (EU) No 528/2012 as it has effect in EU law;

(iii) a Union authorisation granted by the Commission under Article 44 of Regulation (EU) No 528/2012 as it has effect in EU law or under Article 6 of Regulation (EU) No 414/2013 as it has effect in EU law;

(iv) an authorisation granted by the NI competent authority under the simplified procedure in accordance with Article 26 of Regulation (EU) No 528/2012 as it has effect in EU law or Article 6a of Regulation (EU) No 414/2013 as it has effect in EU law;

(v) a biocidal product permitted on the market by the NI competent authority under the Parallel Trade procedure in Article 53(1) of Regulation (EU) No 528/2012 as it has effect in EU law;

(vi) a critical use permit granted in Northern Ireland under Article 55(1) of Regulation (EU) No 528/2012 as it has effect in EU law;

(vii) a provisional authorisation under Article 55(2) of Regulation (EU) No 528/2012 as it has effect in EU law;

(viii) a cultural heritage authorisation granted under Article 55(3) of Regulation (EU) No 528/2012 as it has effect in EU law;

(ix) an essential use authorisation granted under regulation 12 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013.]

Textual Amendments

F8 Art. 17A inserted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 78A (as inserted 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. 27)

F9 Article 18 U.K.Measures geared to the sustainable use of biocidal products

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F9 Art. 18 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. 79; 2020 c. 1, Sch. 5 para. 1(1)

Article 19 U.K.Conditions for granting an authorisation

1. A biocidal product other than those eligible for the simplified authorisation procedure in accordance with Article 25 shall be authorised provided the following conditions are met:

[F10 (a)the active substances are included in [F11 the Simplified Active Substance List] or approved for the relevant product-type and any conditions specified for those active substances are met;]

(b) it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2 of this Article, fulfils the following criteria:

(i)

the biocidal product is sufficiently effective;

(ii)

the biocidal product has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates;

(iii)

the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects;

(iv)

the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations:

• the fate and distribution of the biocidal product in the environment,

• contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation,

• the impact of the biocidal product on non-target organisms,

• the impact of the biocidal product on biodiversity and the ecosystem;

(c) the chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III;

(d) the physical and chemical properties of the biocidal product have been determined and deemed acceptable for the purposes of the appropriate use and transport of the product;

[F10 (e) where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product in accordance with Council Regulation (EEC) No 315/93(1), Regulation (EC) No 396/2005 of the European Parliament and of the Council(2), Regulation (EC) No 470/2009 of the European Parliament and of the Council(3) or Directive 2002/32/EC of the European Parliament and of the Council(4), or specific migration limits or limits for the residual content in food contact materials have been established with respect to such active substances in accordance with Regulation (EC) No 1935/2004 of the European Parliament and of the Council(5);]

(f) where nanomaterials are used in that product, the risk to human health, animal health and the environment has been assessed separately.

2. The evaluation of whether a biocidal product fulfils the criteria set out in point (b) of paragraph 1 shall take into account the following factors:

(a) realistic worst case conditions under which the biocidal product may be used;

(b) the way in which treated articles treated with the biocidal product or containing the biocidal product may be used;

(c) the consequences of use and disposal of the biocidal product;

(d) cumulative effects;

(e) synergistic effects.

3. A biocidal product shall only be authorised for uses for which relevant information has been submitted in accordance with Article 20.

4. A biocidal product shall not be authorised for making available on the market for use by the general public where:

F12 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F10 (b) it meets the criteria according to Regulation (EC) No 1272/2008 for classification as:

• [F10 (b) acute oral toxicity category 1, 2 or 3,

• acute dermal toxicity category 1, 2 or 3,

• acute inhalation toxicity (gases and dust/mist) category 1, 2 or 3,

• acute inhalation toxicity (vapours) category 1 or 2,

• specific target organ toxicity by single or repeated exposure category 1,

• a category 1A or 1B carcinogen,

• a category 1A or 1B mutagen, or

• toxic for reproduction category 1A or 1B;

(c) it consists of, contains or generates, a substance that meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006;]

(d) it has endocrine-disrupting properties; or

(e) it has developmental neurotoxic or immunotoxic effects.

5. Notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public when the criteria referred to in paragraph 4(c) are met, where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation.

The use of a biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised. F13 ...

[F10 6. The assessment of the biocidal product family conducted according to the common principles set out in Annex VI shall consider the maximum risks to human health, animal health and the environment and the minimum level of efficacy over the whole potential range of products within the biocidal product family.

A biocidal product family shall be authorised only if:

(a) the application explicitly identifies the maximum risks to human health, animal health and the environment, and the minimum level of efficacy, on which the assessment is based, as well as the permitted variations in composition and uses referred to in point (s) of Article 3(1) together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures; and

(b) it can be established based on the assessment referred to in the first subparagraph of this paragraph that all the biocidal products within the family comply with the conditions set out in paragraph 1.

7. Where appropriate, the prospective authorisation holder or its representative shall apply for the establishment of maximum residue limits with respect to active substances contained in a biocidal product in accordance with Regulation (EEC) No 315/93, Regulation (EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 2002/32/EC, or for the establishment of specific migration limits or limits for the residual content in food contact materials with respect to such substances in accordance with Regulation (EC) No 1935/2004.]

F14 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9. Where a biocidal product is intended for direct application to the external parts of the human body (epidermis, hair system, nails, lips and external genital organs), or to the teeth and the mucous membranes of the oral cavity, it shall not contain any non-active substance that may not be included in a cosmetic product pursuant to Regulation (EC) No 1223/2009.

Textual Amendments

F10 Substituted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).

F11 Words in Art. 19(1)(a) 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. 80(a); 2020 c. 1, Sch. 5 para. 1(1)

F12 Art. 19(4)(a) 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. 80(b); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Art. 19(5) 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. 80(c); 2020 c. 1, Sch. 5 para. 1(1)

F14 Art. 19(8) 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. 80(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 20 U.K.Requirements for applications for authorisation

1. The applicant for an authorisation shall submit the following documents together with the application:

(a) for biocidal products other than biocidal products meeting the conditions laid down in Article 25:

(i) a dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III;

(ii) a summary of the biocidal product characteristics including the information referred to in points (a), (b) and (e) to (q) of Article 22(2), as applicable;

(iii) a dossier or a letter of access for the biocidal product satisfying the requirements set out in Annex II for each active substance in the biocidal product;

[F15 the competent authority may refuse to accept a letter of access for the purposes of this Article if it does not hold the relevant data.]

(b) for biocidal products that the applicant considers meet the conditions laid down in Article 25:

(i)

a summary of the biocidal product characteristics as referred to in point (a)(ii) of this paragraph;

(ii)

efficacy data; and

(iii)

any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25.

[F16 2. Applications must be submitted in English.]

F17 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F15 Words in Art. 20(1) inserted (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. 81(a); 2020 c. 1, Sch. 5 para. 1(1)

F16 Art. 20(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. 81(b); 2020 c. 1, Sch. 5 para. 1(1)

F17 Art. 20(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. 81(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 21 U.K.Waiving of data requirements

1. By way of derogation from Article 20, the applicant need not provide data required under that Article where any of the following applies:

(a) the data are not necessary owing to the exposure associated with the proposed uses;

(b) it is not scientifically necessary to supply the data; or

(c) it is not technically possible to generate the data.

2. The applicant may propose to adapt the data requirements of Article 20 in accordance with Annex IV. The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with reference to the specific rules in Annex IV.

F18 3.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F18 Art. 21(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. 82; 2020 c. 1, Sch. 5 para. 1(1)

Article 22 U.K.Content of authorisation

1. An authorisation shall stipulate the terms and conditions relating to the making available on the market and use of the single biocidal product or the biocidal product family and include a summary of the biocidal product characteristics.

2. Without prejudice to Articles 66 and 67, the summary of the biocidal product characteristics for a single biocidal product or, in the case of a biocidal product family, the biocidal products within that biocidal product family, shall include the following information:

(a) trade name of the biocidal product;

(b) name and address of the authorisation holder;

(c) date of the authorisation and its date of expiry;

(d) authorisation number of the biocidal product, together with, in the case of a biocidal product family, the suffixes to apply to individual biocidal products within the biocidal product family;

(e) qualitative and quantitative composition in terms of the active substances and non-active substances, knowledge of which is essential for proper use of biocidal products; and in the case of a biocidal product family, the quantitative composition shall indicate a minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0 %;

(f) manufacturers of the biocidal product (names and addresses including location of manufacturing sites);

(g) manufacturers of the active substances (names and addresses including location of manufacturing sites);

(h) type of formulation of the biocidal product;

(i) hazard and precautionary statements;

(j) product-type and, where relevant, an exact description of the authorised use;

(k) target harmful organisms;

(l) application doses and instructions for use;

(m) categories of users;

(n) particulars of likely direct or indirect adverse effects and first aid instructions and emergency measures to protect the environment;

(o) instructions for safe disposal of the product and its packaging;

(p) conditions of storage and shelf-life of the biocidal product under normal conditions of storage;

(q) where relevant, other information about the biocidal product.

Article 23 U.K.Comparative assessment of biocidal products

1. The [F19 competent authority] shall perform a comparative assessment as part of the evaluation of an application for authorisation or for renewal of authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 10(1).

F20 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F10 3. The [F21 competent authority ], shall prohibit or restrict the making available on the market or the use of a biocidal product containing an active substance that is a candidate for substitution where a comparative assessment F22 ... demonstrates that both of the following criteria are met:]

(a) for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents a significantly lower overall risk for human health, animal health and the environment, is sufficiently effective and presents no other significant economic or practical disadvantages;

(b) the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism.

4. By way of derogation from paragraph 1, a biocidal product containing an active substance that is a candidate for substitution may be authorised for a period of up to four years without comparative assessment in exceptional cases where it is necessary to acquire experience first through using that product in practice.

F23 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. Notwithstanding Article 17(4), and without prejudice to paragraph 4 of this Article, an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for a period not exceeding five years and renewed for a period not exceeding five years.

7. Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, that cancellation or amendment of the authorisation shall take effect four years after that decision. However, where the approval of the active substance which is a candidate for substitution expires on an earlier date, the cancellation of the authorisation shall take effect on that earlier date.

Textual Amendments

F10 Substituted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).

F19 Words in Art. 23(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. 83(2); 2020 c. 1, Sch. 5 para. 1(1)

F20 Art. 23(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. 83(3); 2020 c. 1, Sch. 5 para. 1(1)

F21 Words in Art. 23(3) 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. 83(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F22 Words in Art. 23(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. 83(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F23 Art. 23(5) 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. 83(5); 2020 c. 1, Sch. 5 para. 1(1)

F24 Article 24 U.K.Technical guidance notes

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F24 Art. 24 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. 84; 2020 c. 1, Sch. 5 para. 1(1)

[F25 Article 24A U.K.The Simplified Active Substance List

The competent authority must establish, maintain and make electronically available “the Simplified Active Substance List” of active substances that can be used in products that qualify for the simplified authorisation procedure under Article 25 of this Regulation.]

Textual Amendments

F25 Art. 24A inserted (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. 85; 2020 c. 1, Sch. 5 para. 1(1)

(1)

[F10 Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food ( OJ L 37, 13.2.1993, p. 1 ).]

(2)

[F10 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1 ).]

(3)

[F10 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council ( OJ L 152, 16.6.2009, p. 11 ).]

(4)

[F10 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed ( OJ L 140, 30.5.2002, p. 10 ).]

(5)

[F10 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC ( OJ L 338, 13.11.2004, p. 4 ).]

Textual Amendments

F10 Substituted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).