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Commission Implementing Regulation (EU) No 354/2013

of 18 April 2013

on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products(1), and in particular Article 51 thereof,

Whereas:

(1)In order to ensure a harmonised approach, it is appropriate to adopt provisions for changes of biocidal products in respect of any of the information submitted in relation to the initial application for the authorisation or registration of biocidal products and biocidal product families authorised or registered in accordance with Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market(2) and Regulation (EU) No 528/2012.

(2)Proposed changes of biocidal products should be classified in different categories, taking into account the extent to which they require a reassessment of the risk for human or animal health or the environment and of the efficacy of the biocidal product or biocidal product family. It is appropriate to establish the criteria to be used for classifying a change of a product in one of the categories referred to in Article 50(3) of Regulation (EU) No 528/2012.

(3)In order to bring further predictability, the European Chemicals Agency (hereinafter ‘the Agency’) should issue opinions on the classification of changes of products. The Agency should also issue guidelines on the details of the various categories of changes. Those guidelines should be regularly updated in the light of scientific and technical progress.

(4)It is necessary to clarify the procedure which will lead to a decision by the Commission in accordance with the first subparagraph of Article 50(2) of Regulation (EU) No 528/2012 and, where relevant, Article 44(5) thereof.

(5)In order to reduce the overall number of possible applications and to enable Member States, the Agency and the Commission to focus on those changes that have a genuine impact on the properties of biocidal products, an annual reporting system should be introduced for certain changes of an administrative nature. Such changes should not require any prior agreement and should be notified within 12 months following implementation. However, other types of changes of an administrative nature, whose immediate reporting and prior examination is necessary for the continuous supervision of the biocidal product concerned should not be subject to the annual reporting system.

(6)Each change should require a separate submission. Grouping of changes should nevertheless be allowed in certain cases, in order to facilitate the review of the changes and reduce the administrative burden.

(7)Provisions should be introduced regarding the role of the coordination group established under Regulation (EU) No 528/2012 to increase cooperation between Member States and allow for the settlement of disagreements in the evaluation of certain changes.

(8)This Regulation should clarify when the authorisation holder is allowed to implement a given change, as such clarification is essential for economic operators.

(9)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

CHAPTER IGENERAL PROVISIONS

Article 1Subject matter

This Regulation lays down provisions concerning changes of biocidal products sought in accordance with Article 50(2) of Regulation (EU) No 528/2012 with regard to any of the information submitted in relation to the initial application for the authorisation of biocidal products or biocidal product families in accordance with Directive 98/8/EC and Regulation (EU) No 528/2012 (hereinafter ‘changes of products’).

Article 2Classification of changes of products

1.Changes of products are classified in accordance with the criteria laid down in the Annex to this Regulation. Certain categories of changes are listed in the tables of the Annex.

2.The holder of an authorisation may request the competent authority to provide an opinion on the classification in accordance with the criteria laid down in the Annex to this Regulation of a change not listed in one of the tables of that Annex.

The opinion must be delivered within 45 days following receipt of the request and payment of the appropriate fee. In this Regulation, “appropriate fee” means the fee payable for the activity concerned in relations made under section 43 of the Health and Safety at Work etc. Act 1974 where the competent authority is appointed in accordance with regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013.

The competent authority shall publish the opinion after deletion of all information of commercial confidential nature.

Article 3Guidelines on classification

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Article 4Grouping of changes

1.Where several changes of products are sought, a separate notification or application shall be submitted in respect of each change sought.

2.By way of derogation from paragraph 1, the following rules shall apply:

(a)a single notification may cover a series of proposed administrative changes affecting different products in the same manner;

(b)a single notification may cover a series of proposed administrative changes affecting the same product;

(c)a single application may cover more than one proposed change of the same product in the following cases:

(1)

one of the proposed changes in the group is a major change of the product; all other proposed changes in the group are a direct consequence of that change;

(2)

one of the proposed changes in the group is a minor change; all other proposed changes in the group are a direct consequence of that change;

(3)

all changes in the group are a direct consequence of a new classification of the active substance(s) or non-active substance(s) contained in the product or of the product itself;

(4)

all changes in the group are a direct consequence of a specific condition of the authorisation;

(d)a single application may cover more than one proposed change if the competent authority confirms that it is practically feasible to handle those changes in the same procedure.

The single applications referred to in points (c) and (d) of the first subparagraph shall be made in accordance with Article 7 ... where at least one of the proposed changes is a minor change of the product and none of the proposed changes is a major change of the product, and with Article 8 ... where at least one of the proposed changes is a major change of the product.

Article 5Information requirements

An application submitted in accordance with Article 50(2) of Regulation (EU) No 528/2012 shall contain the following:

(1)

the relevant filled application form ..., which shall contain:

(a)

a list of all the authorisations affected by the proposed change(s);

(b)

...

(c)

...

(d)

...

(e)

where relevant, a draft revised summary of the biocidal product characteristics ...,

(1)

...

(2)

...

(2)

a description of all the changes sought;

(3)

where a change leads to or is the consequence of other changes of the terms of the same authorisation, a description of the relation between these changes;

(4)

all relevant supporting documents to demonstrate that the proposed change would not adversely affect the conclusions previously reached concerning the compliance with the conditions set out in Article 19 or 25 of Regulation (EU) No 528/2012; , including any further information requested by the competent authority.

(5)

...

CHAPTER IICHANGES OF AUTHORISED PRODUCTS

Article 6Notification procedure for administrative changes of products

1.The authorisation holder, or its representative, shall submit ... a notification to the competent authority complying with Article 5 and ... pay the appropriate fee .

2.Without prejudice to the second subparagraph, the notification shall be submitted within 12 months following the implementation of the change.

In case of a change referred to in Section 1 of Title 1 of the Annex to this Regulation, the notification shall be submitted before the implementation of the change.

3.Within 30 days following receipt of the notification, where the competent authority disagrees with the change or the relevant fee has not been paid, the competent authority shall inform the authorisation holder, or its representative, ... that the change is rejected and the grounds for the rejection.

If, within 30 days following receipt of the notification, the competent authority has not expressed its disagreement, it shall be deemed to have agreed with the change.

4.Where the competent authority has not rejected the change in accordance with paragraph 3 it shall, where relevant, amend the authorisation of the biocidal product in conformity with the agreed change.

Article 7Procedure for minor changes of products

1.The authorisation holder, or its representative, shall submit ... an application complying with Article 5.

2.The competent authority shall inform the applicant of the appropriate fee . If the applicant fails to pay the fee within 30 days, the competent authority shall reject the application and inform the applicant ... accordingly. Upon receipt of the fee, the competent authority shall accept the application and inform the applicant accordingly indicating the date of acceptance.

2A.Where the application is one that has been resubmitted by virtue of Article 95M of Regulation (EU) No 528/2012, paragraph 2 applies as if for “shall inform the applicant of the appropriate fee” there were substituted “shall inform the applicant before 31st December 2027 of the appropriate fee”.

3.The competent authority shall validate the application within 30 days of its acceptance, if it complies with the requirements laid down in Article 5 and inform the applicant ... accordingly.

In the context of the validation referred to in the first subparagraph, the competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

Where the competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the application to be completed and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 45 days.

The competent authority shall, within 30 days of receipt of the additional information, validate the application if the additional information submitted is sufficient to comply with the requirements laid down in Article 5.

The competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant ... accordingly.

4.Subject to paragraph 4A, within 90 days of validating an application, the competent authority shall evaluate the application and draft an assessment report and shall send its assessment report and, where relevant, the revised summary of the biocidal product characteristics ... to the applicant.

4A.Where an application is validated before 2nd October 2027, the competent authority must, before 31st December 2027—

(a)evaluate the application;

(b)draft an assessment report;

(c)send the report to the applicant; and

(d)where relevant, send the revised summary of the biocidal product characteristics to the applicant.

5.Subject to paragraph 5A, where it appears that additional information is necessary to carry out the evaluation, the competent authority shall ask the applicant to submit such information within a specified time limit. The period referred to in paragraph 4, shall be suspended from the date of the request until the date the information is received. The time limit given to the applicant shall not exceed 45 days in total unless justified by the nature of the data requested or by exceptional circumstances.

The competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant ... accordingly.

5A.Where paragraph 4A applies and it appears that additional information is necessary to carry out the evaluation, the competent authority must ask the applicant to submit such information within a specified time limit. The deadline of 31st December 2027 referred to in paragraph 4A is to be extended by a period equal to the number of days beginning with the date on which the applicant is asked for additional information and ending with the date on which that information is received by the competent authority. But the deadline may not be extended by more than 45 days in total, unless it is justified by the nature of the data requested or by exceptional circumstances.

The competent authority must reject the application if the applicant fails to submit the requested information within the specified time limit and must inform the applicant accordingly.

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7.Where authorisation of the change is granted, the competent authority shall, within 30 days, amend the authorisation of the biocidal product in conformity with the change.

Article 8Procedure for major changes of products

1.The authorisation holder, or its representative, shall submit to the competent authority an application complying with Article 5.

2.The competent authority shall inform the applicant of the appropriate fee . If the applicant fails to pay the fee within 30 days, the competent authority shall reject the application and inform the applicant ... accordingly. Upon receipt of the fee, the competent authority shall accept the application and inform the applicant accordingly indicating the date of acceptance.

2A.Where the application is one that has been resubmitted by virtue of Article 95M of Regulation (EU) No 528/2012, paragraph 2 applies as if for “shall inform the applicant of the appropriate fee” there were substituted “shall inform the applicant before 31st December 2027 of the appropriate fee”.

3.The competent authority shall validate the application within 30 days of its acceptance if it complies with the requirements laid down in Article 5 and inform the applicant ... accordingly.

In the context of the validation referred to in the first subparagraph, the competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

Where the competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirements laid down in Article 5.

The competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant ... accordingly.

4.Subject to paragraph 4A, within 180 days of validating an application, the competent authority shall evaluate the application and draft an assessment report and shall send its assessment report and, where relevant, the revised summary of the biocidal product characteristics ... to the applicant.

4A.Where the application is validated but not authorised before 4th July 2027, the competent authority must, before 31st December 2027—

(a)evaluate the application;

(b)draft an assessment report;

(c)send the report to the applicant; and

(d)where relevant, send the revised summary of the biocidal product characteristics to the applicant.

5.Subject to paragraph 5A where it appears that additional information is necessary to carry out the evaluation, the competent authority shall ask the applicant to submit such information within a specified time limit. The period referred to in paragraph 4 shall be suspended from the date of the request until the date on which the information is received. The time limit given to the applicant shall not exceed 90 days in total unless justified by the nature of the data requested or by exceptional circumstances.

The competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant ... accordingly.

5A.Where paragraph 4A applies and it appears to the competent authority that additional information is necessary to carry out the evaluation, the competent authority must ask the applicant to submit such information within a specified time limit. The deadline of 31st December 2027 referred to in paragraph 4A is to be extended by a period equal to the number of days beginning with the date on which the applicant is asked for additional information and ending with the date on which that information is received by the competent authority. But the deadline may not be extended by more than 90 days in total, unless it is justified by the nature of the data requested or by exceptional circumstances.

The competent authority must reject the application if the applicant fails to submit the requested information within the deadline and must inform the applicant accordingly.

6.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7.Where authorisation of the change is granted, the competent authority shall, within 30 days, amend the authorisation of the biocidal product in conformity with the change.

Article 9Biocidal products authorised in accordance with Article 26 of Regulation (EU) No 528/2012

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Article 9aProcedure for changes already agreed by other Member States

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Article 10Coordination group, arbitration and derogation from mutual recognition

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CHAPTER IIICHANGES OF PRODUCTS AUTHORISED BY THE COMMISSION

Article 11Notification procedure for administrative changes of products

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Article 12Procedure for minor changes of products

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Article 13Procedure for major changes of products

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CHAPTER IVIMPLEMENTATION OF CHANGES

Article 14Administrative changes of products

1.Administrative changes referred to in Section 2 of Title 1 of the Annex may be implemented any time before completion of the procedures laid down in Article 6 .

Administrative changes referred to in Section 1 of Title 1 of the Annex may be implemented at the earliest on the date when the competent authority explicitly agrees with the change, or 45 days following receipt of the notification submitted in accordance with Article 6 , whichever is earliest.

2.Where one of the changes referred to in paragraph 1 is rejected, the authorisation holder shall cease to apply the concerned change within 30 days following notification of the decision of the competent authority .

Article 15Minor changes

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3.Minor changes of a product authorised by the competent authority may be implemented any time after the competent authority has informed the applicant that it has agreed to the change in accordance with Article 7(7).

Article 16Major changes

Major changes may only be implemented after the competent authority has agreed with the change and, where relevant, amended the decision granting the authorisation by the decision referred to in Article 50(2) of Regulation (EU) No 528/2012.

CHAPTER VFINAL PROVISIONS

Article 17Continuous monitoring of implementation of changes

Where requested by the competent authority and for the purpose of monitoring biocidal products placed on the market, authorisation holders shall without delay supply the competent authority with any information related to the implementation of a given change.

Article 18Entry into force

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...

Done at Brussels, 18 April 2013.

For the Commission

The President

José Manuel Barroso

ANNEXCLASSIFICATION OF CHANGES OF PRODUCTS

TITLE 1Administrative changes of products

An administrative change of a product is a change following which any change of the existing authorisation can be expected to be only administrative within the meaning of Article 3(1)(aa) of Regulation (EU) No 528/2012.

SECTION 1Administrative changes of products requiring prior notification before implementation

An administrative change of a product requiring prior notification before implementation is an administrative change, the knowledge of which is important for purposes of control and enforcement. Such changes include those listed in the following table, provided that the conditions therein are met:

Name of the biocidal product
1.Changes of the name of the biocidal product where there is no risk of confusion with the names of other biocidal products.
2.Addition of a name for the biocidal product where there is no risk of confusion with the names of other biocidal products.
Authorisation holder
3.Transfer of the authorisation to a new holder established in the United Kingdom .
4.Change in the name or address of the authorisation holder, which remains in the United Kingdom .
Manufacturer(s) of the active substance(s)
5.Addition of a manufacturer of the active substance or change in the manufacturer’s identity or in manufacturing location or process, where the technical equivalence between the substances from the two manufacturers, manufacturing locations and processes has been established by the competent authority in accordance with Article 54 of Regulation (EU) No 528/2012, and the manufacturer or importer is listed in accordance with Article 95(2) of Regulation (EU) No 528/2012.
Biocidal product family
6.Authorisation as a biocidal product family of a number of authorised products falling within the specifications of a frame-formulation established in accordance with Directive 98/8/EC in accordance with the same terms and conditions.

SECTION 2Administrative changes of products which can be notified after implementation

An administrative change of a product which can be notified after implementation is an administrative change, the knowledge of which is not important for purposes of control and enforcement. Such changes include those listed in the following table, provided that the conditions therein are met:

Authorisation holder
1.Change in other administrative details of the authorisation holder than the name and address.
Formulator(s) of the biocidal product
2.Change in the name, the administrative details or the formulating location of the biocidal product formulator, where the biocidal product composition and the formulating process remain unchanged.
3.Deletion of a formulating location or a formulator of the biocidal product
4.Addition of a formulator of the biocidal product, where the biocidal product composition and the formulating process remain unchanged.
Manufacturer(s) of the active substance(s)
5.Change in the name or the administrative details of a manufacturer of the active substance, where the manufacturing location and process remain unchanged and the manufacturer remains listed in accordance with Article 95(2) of Regulation (EU) No 528/2012
6.Deletion of a manufacturer or a manufacturing location of the active substance
Conditions of use
7.More precise instructions for use, where only wording but not content of instructions are changed.
8.Removal of a particular claim, such as a specific target organism or a specific use.
9.Removal of a category of users.
10.Addition, replacement or modification of a measuring or administration device not relevant for the risk assessment and not regarded as a risk mitigation measure.
Classification and labelling
11.Change to the classification and labelling, where the change is limited to what is necessary to comply with newly applicable requirements of Regulation (EC) No 1272/2008 of the European Parliament and of the Councila.

TITLE 2Minor changes of products

A minor change of a product is a change, following which any change of the existing authorisation can be expected to be minor within the meaning of Article 3(1)(ab) of Regulation (EU) No 528/2012, since the change of the product is not expected to affect the conclusion with regard to the fulfilment of the conditions of Article 19 or 25 of that Regulation. Such changes include the changes listed in the following table, provided that the conditions therein are met:

Composition
1.

Increase or reduction, addition, deletion or replacement of a non-active substance intentionally incorporated in the product, where:

  • The added or increased non active-substance is not a substance of concern.

  • The deletion or reduction of the non-active substance does not lead to an increase of an active substance or a substance of concern.

  • The physical-chemical properties and the shelf-life of the product are expected to remain the same.

  • The risk and efficacy profile are expected to remain the same.

  • A new quantitative risk assessment is not expected to be necessary

2.

Increase, reduction, addition or deletion, or replacement of a non-active substance intentionally incorporated in a biocidal product family outside the authorised range, where:

  • The added or increased non-active substance is not a substance of concern.

  • The deletion or reduction of the non-active substance does not lead to an increase of an active substance or a substance of concern.

  • The physical-chemical properties and the shelf-life of the products of the biocidal product family remain the same.

  • The risk and efficacy profile are expected to remain the same.

  • A new quantitative risk assessment is not expected to be necessary.

Conditions of use
3.Changed instructions for use, where the changes do not adversely affect the exposure
4.

Addition, replacement or modification of a measuring or administration device relevant for the risk assessment and regarded as a risk mitigation measure, where:

  • The new device accurately delivers the required dose for the biocidal product concerned in line with the approved conditions of use.

  • The new device is compatible with the biocidal product.

  • The change is not expected to adversely affect the exposure.

Shelf-life and conditions of storage
5.Change in the shelf-life.
6.Change in the conditions of storage
Pack size
7.

Change in the pack size range, where:

  • New range is consistent with the dose rate and instructions for use as approved in the summary of the biocidal product characteristics.

  • No change of user category.

  • The same risk-mitigation measures apply.

TITLE 3Major changes of products

A major change of a product is a change, following which any change of the existing authorisation can be expected to be major within the meaning of Article 3(1)(ac) of Regulation (EU) No 528/2012, since the change of the product can be expected to affect the conclusion with regard to the fulfilment of the conditions of Article 19 or 25 of that Regulation.

Status: There are currently no known outstanding effects by UK legislation for Commission Implementing Regulation (EU) No 354/2013.
Commission Implementing Regulation(EU) No 354/2013 (2013/354)

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F1Words in Art. 2(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. 179(a) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 63(a)); 2020 c. 1, Sch. 5 para. 1(1)substituted
F2Words in Art. 2(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. 179(b) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 63(b)); 2020 c. 1, Sch. 5 para. 1(1)substituted
F3Words in Art. 2(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. 179(c) (as inserted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 63(c)); 2020 c. 1, Sch. 5 para. 1(1)inserted, substituted
F4Art. 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. 180; 2020 c. 1, Sch. 5 para. 1(1)omitted
F5Words in Art. 4(2)(d) 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. 181(2); 2020 c. 1, Sch. 5 para. 1(1)substituted
F6Words in Art. 4(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. 181(3)(a); 2020 c. 1, Sch. 5 para. 1(1)omitted
F7Words in Art. 4(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. 181(3)(b); 2020 c. 1, Sch. 5 para. 1(1)omitted
F8Words in Art. 5(1) 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. 182(2)(a); 2020 c. 1, Sch. 5 para. 1(1)omitted
F9Art. 5(1)(b)-(d) 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. 182(2)(b); 2020 c. 1, Sch. 5 para. 1(1)omitted
F10Words in Art. 5(1)(e) 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. 182(2)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)omitted
F11Art. 5(1)(e)(1) 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. 182(2)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)omitted
F12Art. 5(1)(e)(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. 182(2)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)omitted
F13Words in Art. 5(4) 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. 182(3); 2020 c. 1, Sch. 5 para. 1(1)inserted
F14Art. 5(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. 182(4); 2020 c. 1, Sch. 5 para. 1(1)omitted
F15Words in Ch. 2 heading 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. 183; 2020 c. 1, Sch. 5 para. 1(1)substituted
F16Words in Art. 6(1) 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. 184(2)(a); 2020 c. 1, Sch. 5 para. 1(1)omitted
F17Words in Art. 6(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. 184(2)(b); 2020 c. 1, Sch. 5 para. 1(1)inserted
F18Words in Art. 6(1) 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. 184(2)(c); 2020 c. 1, Sch. 5 para. 1(1)omitted
F19Words in Art. 6(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. 184(2)(d); 2020 c. 1, Sch. 5 para. 1(1)substituted
F20Words in Art. 6(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. 184(3)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)substituted
F21Words in Art. 6(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. 184(3)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)substituted
F22Words in Art. 6(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. 184(3)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)omitted
F23Words in Art. 6(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. 184(3)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)substituted
F24Word in Art. 6(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. 184(3)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)substituted
F25Words in Art. 6(4) 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. 184(4)(a); 2020 c. 1, Sch. 5 para. 1(1)substituted
F26Word in Art. 6(4) 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. 184(4)(b); 2020 c. 1, Sch. 5 para. 1(1)inserted
F27Words in Art. 7(1) 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. 185(3); 2020 c. 1, Sch. 5 para. 1(1)omitted
F28Words in Art. 7(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. 185(4)(a); 2020 c. 1, Sch. 5 para. 1(1)substituted
F29Words in Art. 7(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. 185(4)(b); 2020 c. 1, Sch. 5 para. 1(1)substituted
F30Words in Art. 7(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. 185(4)(d); 2020 c. 1, Sch. 5 para. 1(1)substituted
F31Words in Art. 7(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. 185(4)(c); 2020 c. 1, Sch. 5 para. 1(1)omitted
F32Art. 7(2A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(2)(a)inserted
F33Words in Art. 7 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. 185(2); 2020 c. 1, Sch. 5 para. 1(1)substituted
F34Words in Art. 7(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. 185(5); 2020 c. 1, Sch. 5 para. 1(1)omitted
F35Words in Art. 7(4) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(2)(b)inserted
F36Words in Art. 7(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. 185(6); 2020 c. 1, Sch. 5 para. 1(1)omitted
F37Art. 7(4A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(2)(c)inserted
F38Words in Art. 7(5) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(2)(d)inserted
F39Words in Art. 7(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. 185(7); 2020 c. 1, Sch. 5 para. 1(1)omitted
F40Art. 7(5A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(2)(e)inserted
F41Art. 7(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. 185(8); 2020 c. 1, Sch. 5 para. 1(1)omitted
F42Art. 7(7) 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. 185(9); 2020 c. 1, Sch. 5 para. 1(1)substituted
F43Words in Art. 8(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. 186(3); 2020 c. 1, Sch. 5 para. 1(1)substituted
F44Words in Art. 8(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. 186(4)(a); 2020 c. 1, Sch. 5 para. 1(1)substituted
F45Words in Art. 8(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. 186(4)(b); 2020 c. 1, Sch. 5 para. 1(1)substituted
F46Words in Art. 8(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. 186(4)(c); 2020 c. 1, Sch. 5 para. 1(1)substituted
F47Words in Art. 8(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. 186(4)(d); 2020 c. 1, Sch. 5 para. 1(1)omitted
F48Art. 8(2A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(a)inserted
F49Words in Art. 8 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. 186(2); 2020 c. 1, Sch. 5 para. 1(1)substituted
F50Words in Art. 8(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. 186(5); 2020 c. 1, Sch. 5 para. 1(1)omitted
F51Words in Art. 8(4) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(b)inserted
F52Words in Art. 8(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. 186(6); 2020 c. 1, Sch. 5 para. 1(1)omitted
F53Art. 8(4A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(c)inserted
F54Words in Art. 8(5) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(d)inserted
F55Words in Art. 8(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. 186(7); 2020 c. 1, Sch. 5 para. 1(1)omitted
F56Art. 8(5A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(e)inserted
F57Art. 8(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. 186(8); 2020 c. 1, Sch. 5 para. 1(1)omitted
F58Art. 8(7) 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. 186(9); 2020 c. 1, Sch. 5 para. 1(1)substituted
F59Arts. 9-13 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. 187; 2020 c. 1, Sch. 5 para. 1(1)omitted
F59Arts. 9-13 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. 187; 2020 c. 1, Sch. 5 para. 1(1)omitted
F59Arts. 9-13 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. 187; 2020 c. 1, Sch. 5 para. 1(1)omitted
F59Arts. 9-13 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. 187; 2020 c. 1, Sch. 5 para. 1(1)omitted
F59Arts. 9-13 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. 187; 2020 c. 1, Sch. 5 para. 1(1)omitted
F59Arts. 9-13 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. 187; 2020 c. 1, Sch. 5 para. 1(1)omitted
F60Words in Art. 14(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. 188(2)(a); 2020 c. 1, Sch. 5 para. 1(1)substituted
F61Words in Art. 14(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. 188(2)(b); 2020 c. 1, Sch. 5 para. 1(1)substituted
F62Words in Art. 14(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. 188(3); 2020 c. 1, Sch. 5 para. 1(1)substituted
F63Art. 15(1) 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. 189(2); 2020 c. 1, Sch. 5 para. 1(1)omitted
F64Art. 15(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. 189(2); 2020 c. 1, Sch. 5 para. 1(1)omitted
F65Words in Art. 15(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. 189(3)(a); 2020 c. 1, Sch. 5 para. 1(1)substituted
F66Words in Art. 15(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. 189(3)(b); 2020 c. 1, Sch. 5 para. 1(1)substituted
F67Words in Art. 15(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. 189(3)(c); 2020 c. 1, Sch. 5 para. 1(1)substituted
F68Words in Art. 16 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. 190; 2020 c. 1, Sch. 5 para. 1(1)substituted
F69Words in Art. 17 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. 191(a); 2020 c. 1, Sch. 5 para. 1(1)substituted
F70Word in Art. 17 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. 191(b); 2020 c. 1, Sch. 5 para. 1(1)substituted
F71Art. 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. 192; 2020 c. 1, Sch. 5 para. 1(1)omitted
F72Words in Art. 18 (including binding words) 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. 192; 2020 c. 1, Sch. 5 para. 1(1)omitted
F73Words in Annex Title 1 Section 1 point 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. 193(2); 2020 c. 1, Sch. 5 para. 1(1)substituted
F74Words in Annex Title 1 Section 1 point 4 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. 193(3); 2020 c. 1, Sch. 5 para. 1(1)substituted
F75Words in Annex Title 1 Section 1 point 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. 193(4); 2020 c. 1, Sch. 5 para. 1(1)substituted
Defined TermSection/ArticleIDScope of Application
appropriate feeart. Article 2 of CHAPTER Iappropriat_rtxwJ6b
changes of productsart. Article 1 of CHAPTER Ichanges_of_rt7i4en

Status of changes to instrument text

The list includes made instruments, both those in force and those yet to come into force. Typically, instruments that are not yet in force (hence their changes are not incorporated into the text above) are indicated by description 'not yet' in the changes made column.