The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019

“SCHEDULE 3Maximum residue level supplementary information fees

Regulation 4(2A)

Fees for the evaluation of supplementary information provided in accordance with Article 14(3) of the MRL Regulation are in accordance with the following table.

Item	Category	Fee (£)
1	Preliminary consideration of application to determine whether the application can proceed further	229
2	Co-ordination of applications	1,872
3	Simple reasoned case(1)	416
4	Analytical method(2)	416
5	Toxicology(3)	3,120
6	Metabolism and residues evaluation(4)	6,760
7	Residues evaluation(5)	2,028
Notes
(1) This category is for an MRL supplementary information requirement to provide additional information on aspects of the data already evaluated or to provide evidence of the commercial availability of standards for MRL compliance.
(2) This category is for an MRL supplementary information requirement to provide an analytical method for MRL compliance.
(3) This category is for an MRL supplementary information requirement to address the toxicological relevance of a metabolite identified in plants or products of animal origin.
(4) This category is for an MRL supplementary information requirement to address plant or livestock metabolism or any other nature of residue study.
(5) This category is for an MRL supplementary information requirement to provide additional residue trials or any other magnitude of residue study including monitoring data.
Fees for multiple submissions to address MRL supplementary information for the same active substance are calculated on a modular basis with a charge applied for each MRL supplementary information requirement. Large or novel studies to address MRL supplementary information requirements will incur an additional fee, as a multiple of the original fee, if significant extra work is required over and above the usual level for the module in question. ”

“7.

(1)

For the purposes of the PIC Regulation, the Designated National Authority is—

(a)

in England, Scotland and Wales, the Great Britain Executive;

(b)

in Northern Ireland, the Northern Ireland Executive.

(2)

The Designated National Authority is responsible for controlling the export and import of chemicals listed in Parts 1, 2 and 3 of the UK PIC list, in accordance with Article 18 of the PIC Regulation.

(3)

In paragraph (2), the “UK PIC list” means the list established and maintained in accordance with Articles 7 and 23 of the PIC Regulation.”

“42.

UK mandatory classification and labelling list: the list of mandatory classification and labelling requirements of substances and groups of substances established and maintained in accordance with Article 38A of Regulation (EC) No 1272/2008.

43.

UK notification database: the database established in accordance with Article 42 of Regulation (EC) No 1272/2008.”

“2.

Active substances manufactured or imported for use in biocidal products only and included either in the UK List or the Simplified Active Substance List defined in Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products or Annex II of Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council, subject to the transitional measures detailed in Article 89 of Regulation (EU) No 528/2012, shall be regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title.”

“Article 37

Procedure for mandatory classification and labelling where the EU Risk Assessment Committee publishes an opinion

1.

This Article applies in relation to a substance—

(a)

on which the Committee for Risk Assessment of the European Chemicals Agency (“the Committee”) publishes an opinion under Article 37(4) of the EU CLP Regulation on or after exit day; or

(b)

on which the Committee has published an opinion under Article 37(4) of the EU CLP Regulation before exit day, but which has not, as at exit day, been included in Part 3 of Annex VI of the CLP Regulation.

2.

Within 6 months of the publication of the Committee’s opinion, the Agency must publish its own opinion.

3.

Where the Agency’s opinion recommends aligning with the Committee’s opinion that there should be a change—

(a)

the Agency must, within 12 months of the publication of its opinion, submit a recommendation to the Secretary of State to give effect to the classification and labelling requirement set out in the Agency’s opinion, and must send a copy of that recommendation to each of the Devolved Authorities;

(b)

the Secretary of State must decide whether to accept that recommendation and must publish that decision, together with the reasons for that decision, and specifying the date when any new or revised classification and labelling requirement is to be included in the UK mandatory classification and labelling list;

(c)

the Secretary of State’s function under point (b) is subject to the consent requirement in Article 53B;

(d)

the Agency must without undue delay update the UK mandatory classification and labelling list in accordance with the Secretary of State’s decision.

4.

Where the Agency’s opinion does not recommend aligning with the Committee’s opinion, the Agency may produce a proposal under paragraph 2 of Article 37A for a new or revised mandatory classification and labelling requirement.”

“Article 37A

Procedure where Article 37(1) does not apply

1.

This Article applies in relation to substances to which Article 37(1) does not apply.

2.

(1)

The Agency may produce a proposal for a new or revised mandatory classification and labelling requirement and, where appropriate, specific concentration limits or M-factors.

(2)

A Competent Authority may submit to the Agency a proposal for a new or revised mandatory classification and labelling requirement and, where appropriate, specific concentration limits or M-factors.

(3)

A proposal under sub-paragraph (1) or (2) must follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.

3.

(1)

A manufacturer, importer or downstream user of a substance may submit to the Agency a proposal for a mandatory classification of that substance, and, where appropriate, specific concentration limits or M-factors, provided that there is no entry in the UK mandatory classification and labelling list for such substance in relation to the hazard class or differentiation covered by that proposal.

(2)

A manufacturer, importer or downstream user who has new information which may lead to a change of the mandatory classification and labelling elements of a substance in the UK mandatory classification and labelling list must submit a proposal to the Agency for a revised classification.

(3)

A proposal under subparagraph (1) or (2) must follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.

(4)

Where a proposal under subparagraph (1) concerns the mandatory classification and labelling of a substance in accordance with Article 36(3), it must be accompanied by a fee.

4.

Within 12 months of a proposal being received by or produced by the Agency, the Agency must publish an opinion on the proposal, after giving the parties concerned the opportunity to comment.

5.

Where the Agency considers that it is appropriate to impose or revise a mandatory classification and labelling requirement, it must within 12 months submit a recommendation to the Secretary of State to give effect to the opinion, and must send a copy to each of the Devolved Authorities.

6.

The Secretary of State must decide whether to accept the recommendation and must publish that decision, together with the reasons for that decision, specifying the date when any new or revised classification is to be included on the UK mandatory classification and labelling list.

7.

The Secretary of State’s function under paragraph 6 is subject to the consent requirement in Article 53B.

8.

Where the Secretary of State’s decision is to accept the recommendation, the Agency must without undue delay amend the UK mandatory classification and labelling list in accordance with that decision.”

“Article 38A

UK mandatory classification and labelling list

The Agency must establish, maintain and publish electronically a list (to be called “the UK mandatory classification and labelling list”) of all the mandatory classifications and accompanying labelling requirements made by the Secretary of State in accordance with Article 37 and Article 37A.”

“Article 52

Safeguard clause

1.

The Secretary of State or a Devolved Authority may take appropriate provisional measures in respect of a substance or mixture if they—

(a)

have justifiable grounds for believing that the substance or mixture, although satisfying the requirements of this Regulation, constitutes a serious risk to human health or the environment due to reasons of classification, labelling or packaging; and

(b)

have competence to take the provisional measures, within the meaning of paragraphs 6 to 10.

2.

A provisional measure taken by a Devolved Authority applies only in relation to the territory in relation to which it has competence.

3.

Where the Secretary of State takes a provisional measure, the Secretary of State must immediately inform the Devolved Authorities, giving the reasons for the decision. Where a Devolved Authority takes a provisional measure, it must immediately inform the other Devolved Authorities and the Secretary of State, giving the reasons for the decision.

4.

Within 90 days of a provisional measure being taken—

(a)

in the case of a provisional measure relating to classification or labelling of a substance—

(i)

where the Secretary of State took the measure, the Secretary of State must request the Agency to produce a proposal for a new or revised mandatory classification and labelling requirement under Article 37A(2),

(ii)

where a Devolved Authority took the measure, the Competent Authority for that country must request the Agency to produce a proposal for a new or revised mandatory classification and labelling requirement under Article 37A(2);

(b)

in the case of a provisional measure that falls within the scope of Article 53—

(i)

where the Secretary of State took the measure, the Secretary of State must decide whether or not to make the measure permanent by making regulations under Article 53,

(ii)

where a Devolved Authority took the measure, it must decide whether or not to request the Secretary of State to make the measure permanent by making regulations under Article 53.

5.

The taker of the provisional measure must revoke that measure, when—

(a)

in the case of a provisional measure relating to the classification or labelling of a substance, the Secretary of State makes a decision under Article 37A;

(b)

in the case of a provisional measure that falls within the scope of Article 53—

(i)

where paragraph 4(b)(i) of this Article applies, the Secretary of State either decides not to make the measure permanent or makes regulations under Article 53 to make the measure permanent, or

(ii)

where paragraph 4(b)(ii) of this Article applies, the Devolved Authority decides not to request the Secretary of State to make the measure permanent.

6.

The Secretary of State has competence to take a provisional measure if, or to the extent that, the exercise of the function to take that measure—

(a)

relates to England;

(b)

relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 199855);

(c)

relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 200656);

(d)

relates to Northern Ireland and is not within devolved competence in Northern Ireland.

7.

The Scottish Ministers have competence to take a provisional measure if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).

8.

The Welsh Ministers have competence to take a provisional measure if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).

9.

A Department in Northern Ireland has competence to take a provisional measure if, or to the extent that, the exercise of the function to take that measure is within devolved competence in Northern Ireland.

10.

For the purposes of paragraph 9, the exercise of the function of taking a provisional measure is within devolved competence in Northern Ireland except so far as a provision of an Act of the Northern Ireland Assembly conferring the function of taking that provisional measure would be outside the legislative competence of the Assembly.

The references in this paragraph to provision being outside the legislative competence of the Northern Ireland Assembly are to be read in accordance with section 6 of the Northern Ireland Act 199857.

Any provision that would be outside the legislative competence of the Northern Ireland Assembly unless the Secretary of State consented to it is to be regarded, for the purposes of this paragraph, as outside legislative competence.”

“Article 53A

Regulation making power

1.

Any power to make regulations conferred on the Secretary of State by this Regulation is exercisable by statutory instrument.

2.

Such regulations may—

(a)

contain incidental, supplemental, consequential and transitional provision; and

(b)

may make different provision for different purposes.

3.

A statutory instrument containing regulations made under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.

4.

The function of making regulations under this Regulation is subject to the consent requirement in Article 53B.

Article 53B

The consent requirement

1.

Where any provision of this Regulation states that a function is subject to the consent requirement in this Article, the function may be exercised in a particular instance only if the person exercising it has obtained the consent or consents (if any) required by paragraphs 2 to 4.

2.

The consent of the Scottish Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 54 of the Scotland Act 199858) whether or not the exercise of the function also relates to a part of the United Kingdom other than Scotland.

3.

The consent of the Welsh Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 200659) whether or not the exercise of the function also relates to a part of the United Kingdom other than Wales.

4.

The consent of a Northern Ireland Department is required if, or to the extent that, the exercise of the function is within devolved competence, whether or not the exercise of the function also relates to a part of the United Kingdom other than Northern Ireland. The exercise of the function is within devolved competence for the purposes of this paragraph unless it is outside competence by virtue of paragraph 5 or 6.

5.

It is outside devolved competence—

(a)

to make any provision by subordinate legislation which would be outside the legislative competence of the Northern Ireland Assembly if it were included in an Act of the Assembly; or

(b)

to confirm or approve subordinate legislation containing such provision.

6.

In the case of any function other than a function of making, confirming or approving subordinate legislation, it is outside devolved competence to exercise the function (or exercise it in any way) so far as a provision of an act of the Northern Ireland Assembly conferring the function (or, as the case may be, conferring it so as to be exercisable in that way) would be outside the legislative competence of the Assembly.

7.

References in paragraph 5 and 6 to provision being outside the legislative competence of the Northern Ireland Assembly are to be read in accordance with section 6 of the Northern Ireland Act 199860. Any provision that would be outside the legislative competence of the Northern Ireland Assembly unless the Secretary of State consented to it is to be regarded, for the purposes of paragraphs 5 and 6, as outside legislative competence.”

“Article 8AThe UK List

The competent authority shall establish, maintain and make electronically available to the public a list of approved active substances (“the UK List”).”

“Article 15Review of approval of an active substance

1.

The Secretary of State may review the approval of an active substance for one or more product-types at any time where there are significant indications that the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2) are no longer met. The Secretary of State may also review the approval of an active substance for one or more product-types at the request of the competent authority if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles. The Secretary of State shall make publically available the information that it is carrying out a review and shall provide an opportunity for the applicant to submit comments. The Secretary of State shall take due account of those comments in the review.

2.

Where any of the Devolved Authorities proposes that an active substance should be reviewed the Secretary of State shall have regard to such proposals in deciding whether to review the approval of an active substance.

3.

Where those indications are confirmed, the Secretary of State shall issue a decision amending the conditions of approval of an active substance or cancelling its approval. Article 9(2) shall apply. The competent authority shall inform the initial applicants for the approval accordingly.

4.

On duly justified imperative grounds of urgency the Secretary of State may issue immediately applicable decisions.

5.

Paragraphs 1, 3 and 4 are subject to the consent requirement.

6.

Where the Secretary of State decides to cancel or amend the approval of an active substance for one or more product-types the competent authority shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance. Articles 48 and 52 shall apply accordingly.”

“Article 24AThe 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.”

“Article 55Derogation from the requirements

1.

By way of derogation from Articles 17 and 19, the competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means.

On receipt of a reasoned request from the competent authority, the Secretary of State or a Devolved Authority shall issue a decision, with or without conditions, on whether the action taken may be extended for a period not exceeding 550 days if they have competence to exercise the derogation within the meaning in paragraphs 4 to 8.

2.

By way of derogation from point (a) of Article 19(1) and until an active substance is approved, the competent authority may authorise, for a period not exceeding three years, a biocidal product containing a new active substance.

Such a provisional authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 8, the competent authority has produced an assessment report and evaluation conclusions on the new active substance and consider that the biocidal product is expected to comply with points (b), (c) and (d) of Article 19(1) taking into account the factors set out in Article 19(2).

If the Secretary of State decides not to approve the new active substance, the competent authority shall cancel that authorisation.

Where a decision on the approval of the new active substance has not yet been made by the Secretary of State when the period of three years expires, the competent authority may extend the provisional authorisation for a period not exceeding one year, provided that there are good reasons to believe that the active substance will satisfy the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2).

3.

By way of derogation from point (a) of Article 19(1), the Secretary of State or a Devolved Authority shall issue a decision allowing the competent authority to authorise a biocidal product containing a non-approved active substance if the Secretary of State or a Devolved Authority is satisfied that that active substance is essential for the protection of cultural heritage and that no appropriate alternatives are available. To obtain such a derogation, the competent authority shall apply to the Secretary of State or a Devolved Authority providing due justification.

4.

The Secretary of State has competence to grant a derogation under paragraph 1 or 3 if, or to the extent that, the exercise of the function to take that measure—

(a)

relates to England;

(b)

relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 199865);

(c)

relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 200666);

(d)

relates to Northern Ireland and is not within devolved competence in Northern Ireland as set out in paragraphs 7 and 8.

5.

The Scottish Ministers have competence to grant a derogation under paragraph 1 or 3 if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).

6.

The Welsh Ministers have competence to exercise a derogation under paragraph 1 or 3 if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).

7.

A Department in Northern Ireland has competence to exercise a derogation under paragraph 1 or 3 if, or to the extent that, the function to take that measure is within devolved competence in Northern Ireland.

8.

For the purposes of paragraph 7, the exercise of the function of exercising a derogation is within devolved competence in Northern Ireland except so far as a provision of an Act of the Northern Ireland Assembly conferring the function of taking that provisional measure would be outside the legislative competence of the Assembly.

The references in this paragraph to provision being outside the legislative competence of the Northern Ireland Assembly are to be read in accordance with section 6 of the Northern Ireland Act 1998.

Any provision that would be outside the legislative competence of the Northern Ireland Assembly unless the Secretary of State consented to it is to be regarded, for the purposes of this paragraph, as outside legislative competence.

9.

Where the Secretary of State grants a derogation, the Secretary of State must immediately inform the Devolved Authorities giving reasons for the decision. Where a Devolved Authority exercises a derogation, it must immediately inform the other Devolved Authorities and the Secretary of State giving reasons for the decision.”

“Article 77Appeals

1.

Appeals against decisions of the competent authority taken pursuant to this Regulation shall be available:

(a)

in Great Britain as provided for in regulation 14 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 201369;

(b)

in Northern Ireland as provided for in regulation 13 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 201370.

2.

Fees may be payable as appropriate by the person bringing an appeal.

3.

An appeal lodged pursuant to paragraph 1 shall have suspensive effect.”

“Article 79Formats for submission of information to the competent authority

The competent authority shall specify formats for submission of information. Applicants shall use these formats in their submissions to the competent authority pursuant to this Regulation.”

“Article 83ARegulation procedure

1.

Regulations made by the Secretary of State under this Regulation are to be made by statutory instrument.

2.

Such regulations may—

(a)

contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments);

(b)

make different provision for different purposes.

3.

A statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.

Article 83BThe consent requirement

1.

Where any provision of this Regulation states that a function is subject to the consent requirement, the function may be exercised in a particular instance only if the person exercising it has obtained the consent or consents (if any) required by paragraphs 2 to 4.

2.

The consent of the Scottish Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 54 of the Scotland Act 199871) whether or not the exercise of the function also relates to a part of the United Kingdom other than Scotland.

3.

The consent of the Welsh Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 200672) whether or not the exercise of the function also relates to a part of the United Kingdom other than Wales.

4.

The consent of a Northern Ireland Department is required if, or to the extent that, the exercise of the function is within devolved competence, whether or not the exercise of the function also relates to a part of the United Kingdom other than Northern Ireland. The exercise of the function is within devolved competence for the purposes of this paragraph unless it is outside competence by virtue of paragraph 5 or 6.

5.

It is outside devolved competence—

(a)

to make any provision by subordinate legislation which would be outside the legislative competence of the Northern Ireland Assembly if it were included in an Act of the Assembly; or

(b)

to confirm or approve subordinate legislation containing such provision.

6.

In the case of any function other than a function of making, confirming or approving subordinate legislation, it is outside devolved competence to exercise the function (or exercise it in any way) so far as a provision of an act of the Northern Ireland Assembly conferring the function (or, as the case may be, conferring it so as to be exercisable in that way) would be outside the legislative competence of the Assembly.

7.

References in paragraphs 5 and 6 to provision being outside the legislative competence of the Northern Ireland Assembly are to be read in accordance with section 6 of the Northern Ireland Act 199873. Any provision that would be outside the legislative competence of the Northern Ireland Assembly unless the Secretary of State consented to it is to be regarded, for the purposes of paragraphs 5 and 6, as outside legislative competence.”

“Article 85Adaptation to scientific and technical progress

1.

The Secretary of State may by regulations amend Annexes II, III and IV to this Regulation to take account of current scientific and technical knowledge.

2.

Regulations made under paragraph 1 above shall be subject to the consent requirement.”

“Article 88Safeguard clause

1.

Where on the basis of new evidence the competent authority has justifiable grounds to consider that a biocidal product, although authorised in accordance with this Regulation, constitutes a serious immediate or long-term risk to the health of humans, particularly of vulnerable groups, or animals, or to the environment, it may take appropriate provisional measures.

2.

The Secretary of State or a Devolved Authority shall issue a decision to either permit the provisional measure for a time period defined in the decision or require the competent authority to revoke the provisional measure if they have competence to issue the decision within the meaning in paragraphs 3 to 7.

3.

The Secretary of State has competence to issue a decision if, or to the extent that, the exercise of the function to take that measure—

(a)

relates to England;

(b)

relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 1998);

(c)

relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006);

(d)

relates to Northern Ireland and is not within devolved competence in Northern Ireland as set out in paragraphs 6 and 7.

4.

The Scottish Ministers have competence to issue the decision if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).

5.

The Welsh Ministers have competence to issue a decision if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).

6.

A Department in Northern Ireland has competence to issue a decision if, or to the extent that, the exercise of the function to take that measure is within devolved competence in Northern Ireland.

7.

For the purposes of paragraph 6, the exercise of the function of issuing a decision is within devolved competence in Northern Ireland except so far as a provision of an Act of the Northern Ireland Assembly conferring the function of taking that measure would be outside the legislative competence of the Assembly.

The references in this paragraph to provision being outside the legislative competence of the Northern Ireland Assembly are to be read in accordance with section 6 of the Northern Ireland Act 1998.

Any provision that would be outside the legislative competence of the Northern Ireland Assembly unless the Secretary of State consented to it is to be regarded, for the purposes of this paragraph, as outside legislative competence.

8.

Where the Secretary of State issues the decision under paragraph 2 the Secretary of State must immediately inform the Devolved Authorities giving reasons for the decision. Where a Devolved Authority issues the decision under paragraph 2, it must immediately inform the other Devolved Authorities and the Secretary of State giving reasons for the decision.”

“Article 89Existing transitional measures

1.

The competent authority shall carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with Article 16(2) of Directive 98/8/EC with the aim of achieving it by 31 December 2024.

2.

The Secretary of State may by regulations—

(a)

extend the date for the systematic examination of all existing active substances referred to in this Article;

(b)

specify matters in relation to the carrying out of the work programme and the related rights and obligations of the competent authority and the participants in the programme.

3.

Where any of the Devolved Authorities makes proposals in relation to regulations under paragraph 2, the Secretary of State must have regard to such proposals in deciding whether to exercise functions under that paragraph.

4.

Regulations made under paragraph 2 above are subject to the consent requirement.

5.

In order to facilitate a smooth transition from Directive 98/8/EC to this Regulation, during the work programme the Secretary of State shall either issue decisions providing that an active substance is approved, and under which conditions, or, in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, issue decisions stating that an active substance is not approved. Decisions approving an active substance shall specify the date of approval. Article 9(2) shall apply.

6.

A decision made under paragraph 5 is subject to the consent requirement.

7.

By way of derogation from Articles 17(1), 19(1) and 20(1) of this Regulation, and without prejudice to paragraphs 1, 2 and 9 of this Article, the current system or practice of making available on the market or using a given biocidal product continues to apply for up to three years after the date of approval of the last of the active substances to be approved in that biocidal product. The competent authority may, in accordance with the current system or practice, authorise the making available on the market or use of a biocidal product containing only—

(a)

existing active substances which—

(i)

have been evaluated under Commission Regulation (EC) No 1062/2014 but which have not yet been approved of that product-type;

(ii)

are being evaluated under that Regulation but have not yet been approved for that product-type; or

(b)

a combination of active substances referred to in point (a) and active substances approved in accordance with this Regulation.

8.

By way of derogation from paragraph 7, in the case of a decision not to approve an active substance, the competent authority may continue to apply its current system or practice of making biocidal products available on the market for up to 12 months after the date of the decision not to approve an active substance in accordance with paragraph 5, and may continue to apply the current system or practice of using biocidal products for up to 18 months after that decision.

9.

Following a decision to approve a particular active substance for a specific product-type, the competent authority shall ensure that authorisations for biocidal products of that product-type and containing that active substance are granted, modified or cancelled, as appropriate, in accordance with this Regulation within three years of the date of approval.

To that effect, those wishing to apply for the authorisation of biocidal products of that product-type containing no active substances other than existing active substances shall submit applications for authorisation no later than the date of approval of the active substance or substances. In the case of biocidal products containing more than one active substance, applications shall be submitted no later than the date of approval of the last active substance for that product-type.

10.

Where no application for authorisation has been submitted in accordance with paragraph 9 above—

(a)

the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance or substances; and

(b)

use of existing stocks of the biocidal product may continue for up to 365 days after the date of approval of the active substance or substances.

11.

Where the competent authority decides to reject an application submitted in accordance with paragraph 9 for authorisation of a biocidal product already made available on the market, or decides not to grant an authorisation or to impose conditions for the authorisation making it necessary to change such a product, the following shall apply—

(a)

a biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market with effect from 180 days after the date of the decision of the competent authority; and

(b)

use of existing stocks of the biocidal product may continue for up to 365 days after the date of the decision of the competent authority.”

“1A. The competent authority may request further data relating to the original authorisation as necessary.

1B. It is the duty of the authorisation holder to provide the necessary data within 60 days of such a request.

1C. The competent authority may cancel the authorisation if this Article is not complied with and the period of grace set out in the second paragraph of Article 52 shall apply.”

“Article 95ATransitional measures for simplified notification procedure

1.

Where a product was authorised in a country which was a Member State of the EU other than the United Kingdom prior to exit day in accordance with Article 26 of Regulation (EU) No 528/2012 and placed on the market in the United Kingdom in accordance with Article 27 of Regulation (EU) No 528/2012—

(a)

it is to be treated as if it were authorised by the competent authority under Article 26 of this Regulation; and

(b)

the competent authority shall grant an authorisation under Article 26 of this Regulation.

2.

The authorisation shall be cancelled and Article 52 of this Regulation shall apply where—

(a)

the authorisation holder is not established in the United Kingdom within 12 months after exit day; or

(b)

the authorisation holder does not supply the competent authority with relevant scientific and authorisation data—

(i)

by the date of any application for an amendment to the authorisation under Article 50 of this Regulation; or

(ii)

within 60 days of any request made by the competent authority to the authorisation holder

whichever is earlier.

Article 95BTransitional measures for mutual recognition applications

1.

This Article applies where an application for mutual recognition of a national authorisation of a biocidal product has been made before exit day in accordance with Article 33, 34 or 39 of this Regulation and where a decision on authorisation had not been made before exit day.

2.

Paragraphs 3, 4, 7 and 8 apply where the United Kingdom was the reference Member State, before exit day, for an application for mutual recognition under Article 34 of Regulation (EU) No 528/2012.

3.

The application for mutual recognition shall be treated as having been made under Article 29 of this Regulation and the time limits under Articles 29 and 30 shall be suspended until—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 90 days from exit day.

4.

On receipt of the resubmitted application and data to the competent authority, the time limits under Articles 29 and 30 of this Regulation shall apply less any time which expired between the date of acceptance of the application and data under Article 34 of Regulation (EU) No 528/2012 and exit day.

5.

Paragraphs 6, 7 and 8 apply where the United Kingdom was, before exit day, the Member State concerned in relation to an application for mutual recognition under Articles 33, 34 or 39 of Regulation (EU) No 528/2012.

6.

The application shall be treated as having been made under Article 29 of this Regulation and shall be subject to the time limits under Articles 29 and 30 from—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 180 days from exit day.

7.

Where the applicant does not meet the requirements of this Article, the application shall be rejected by the competent authority and Article 89(11) shall apply as if the application had been submitted in accordance with Article 89(9).

8.

Anything done before exit day by the United Kingdom, either as the Member State concerned or as the reference Member State is taken to have been done by the competent authority under this Regulation.

Article 95CRenewal of authorisations subject to mutual recognition under Regulation 492/2014

1.

This Article applies where an application for the renewal of a biocidal product authorisation subject to mutual recognition was made before exit day in accordance with Article 3 of Commission Delegated Regulation (EU) No 492/2014 of 7 March 2014 supplementing Regulation No 528/2012 of the European Parliament and of the Council as regards the rules for the renewal of authorisations of biocidal products subject to mutual recognition, where a decision on the renewal of the authorisation had not been made before exit day.

2.

Paragraph 3 applies where the United Kingdom was the reference Member State, before exit day, for an application for renewal.

3.

The application shall be treated as having been made under Article 31 of this Regulation and the time limits under Article 31 shall be suspended until—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 90 days from exit day.

4.

On receipt of the resubmitted application and data to the competent authority, the time limits under Articles 30 and 31 (where applicable) of this Regulation shall apply less any time which expired between the date of acceptance of the application and data under Articles 3 and 4 of Regulation (EU) No 492/201474 and exit day.

5.

Paragraph 6 applies where the United Kingdom was a Member State concerned, before exit day, for an application for renewal.

6.

The application shall be treated as having been made under Article 31 of this Regulation and shall be subject to the time limits under Articles 30 and 31 (where applicable) from—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 180 days from exit day.

7.

Anything done before exit day by the United Kingdom, either as the Member State concerned or as the reference Member State, is taken to have been done by the competent authority under this Regulation.

Article 95DTransitional measures for national authorisation applications

1.

This Article shall apply to an application made, before exit day, under Article 29 or Article 31 of Regulation (EU) No 528/2012 and where a decision on authorisation or renewal has not been made before exit day.

2.

The application shall be treated as having been made under this Regulation and the time limits under Articles 29, 30 and 31 as appropriate shall be suspended until—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 90 days from exit day.

3.

Where the applicant does not meet the requirements of this Article, the application shall be—

(a)

cancelled by the competent authority and Article 52 shall apply; or

(b)

rejected by the competent authority and Article 89(11) shall apply as if the application had been submitted in accordance with Article 89(9).

4.

Anything done before exit day by the United Kingdom, as the receiving competent authority, is taken to have been done by the competent authority under this Regulation.

Article 95ETransitional Measures Simplified Authorisation Applications

1.

This Article shall apply to an application made before exit day under Article 25 or 26 of Regulation (EU) No 528/2012 and where a decision on authorisation has not been made before exit day.

2.

Where the application was made to the United Kingdom as the receiving competent authority, the application shall be treated as having been made under this Regulation and the time limits under Article 26 shall be suspended until—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 90 days from exit day.

3.

Where the application was made and the United Kingdom was not the receiving competent authority, the application shall be treated as having been made under this Regulation and the time limits under Article 26 shall be suspended until the date on which—

(a)

the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 180 days from exit day.

4.

Where the applicant does not meet the requirements of this Article, the application shall be rejected by the competent authority and Article 89(11) shall apply as if the application had been submitted in accordance with Article 89(9).

5.

Anything done before exit day by the United Kingdom, as the receiving competent authority, is taken to have been done by the competent authority under this Regulation.

Article 95FTransitional measures for applications for same biocidal product authorisations

1.

This Article applies to an application under Article 3 or 4a of Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council75, and where a decision on authorisation has not been made before exit day.

2.

The application shall be treated as having been made under Article 3 or 4a (as appropriate) of Regulation 414/2013 and the time limits under those Articles shall be suspended until—

(a)

the date on which the applicant either resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 90 days from exit day.

3.

Where the applicant does not meet the requirements of this Article, the application shall be rejected by the competent authority and Article 89(11) shall apply as if the application had been submitted in accordance with Article 89(9).

4.

For the purposes of this Article, data submitted by the applicant or the data owner shall include relevant data on the reference product.

Article 95GTransitional measures for Regulation (EU) No 528/2012 authorisations

1.

This Article applies to authorisations granted before exit day under Articles 19, 26, 30, 31, 33, 34, 36, 39 or 44 of Regulation (EU) No 528/2012.

2.

The authorisation is to be treated as if it were authorised by the competent authority under the relevant Article of this Regulation.

3.

The authorisation shall be cancelled and Article 52 of this Regulation shall apply where—

(a)

the authorisation holder is not established in the United Kingdom within 365 days after exit day; or

(b)

the authorisation holder does not supply the competent authority with relevant scientific and authorisation data—

(i)

by the date of any application for renewal or the date of any application for amendment to the authorisation under Article 50; or

(ii)

within 60 days of any request made by the competent authority to the authorisation holder

whichever is earlier.

Article 95HTransitional measures for ongoing applications for Union authorisations

1.

This Article applies to an application for Union authorisation made in accordance with Article 42, 43 or 45 and evaluated under either Article 44 or Article 46 of Regulation (EU) No 528/2012, and where a decision on authorisation has not been made before exit day.

2.

Paragraph 3 applies where, prior to exit day, the United Kingdom was the evaluating competent authority for applications for Union authorisation made under Regulation (EU) No 528/2012.

3.

The application shall be taken as being made under Article 29 or 31 of this Regulation and the time limits under Article 29, 30 or 31 shall be suspended until—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 90 days from exit day.

4.

On receipt of the resubmitted application and data to the competent authority, the time limits under Article 29, 30 or 31 of this Regulation shall apply less any time which expired between the date of acceptance of the application and data under Article 43, 44, 45 or 46 of Regulation (EU) No 528/2012 and exit day.

5.

Paragraph 6 applies where, prior to exit day, the United Kingdom was not the evaluating competent authority for applications for Union authorisation made under Regulation (EU) No 528/2012.

6.

The application shall be treated as having been made under Article 29, 30 or 31 of this Regulation and shall be subject to the time limits under those Articles from—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which:

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided the date is within 180 days from exit day.

7.

Where the applicant or authorisation holder does not meet the requirements of this Article, the application shall be—

(a)

cancelled by the competent authority and Article 52 shall apply; or

(b)

rejected by the competent authority and Article 89(11) shall apply as if the application had been submitted in accordance with Article 89(9).

8.

Anything done before exit day by the United Kingdom, as the evaluating competent authority, is taken to have been done by the competent authority under this Regulation.

Article 95ITransitional measures Article 95 List

1.

This Article applies to the list prepared pursuant to Article 95 of Regulation (EU) No 528/2012 (“the Article 95 pre-exit day List”).

2.

The entries included on the Article 95 pre-exit day List shall be included in the list prepared pursuant to Article 95 of this regulation (“the Article 95 List”) subject to paragraph 3 below.

3.

An entry on the Article 95 List shall be removed if the following conditions are not met within 2 years from exit day—

(a)

the person is established in the United Kingdom; and

(b)

the person provides to the competent authority—

(i)

a complete substance dossier for the relevant substance;

(ii)

a reference to a complete substance dossier for which all data protection periods have expired and the competent authority is able to obtain all the data;

(iii)

a letter of access to the complete substance dossier and the data owner has submitted the data to the competent authority and the competent authority holds the data after exit day.

4.

Where an entry is removed from the Article 95 List for reasons beyond the control of the supplier of a biocidal product containing the relevant active substance, the competent authority may grant a period of grace for the making available on the market of that biocidal product except in cases where the continued making available on the market of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment.

A period of grace in excess of 180 days may only be granted in exceptional circumstances.

5.

Where a period of grace is granted and the supplier of a biocidal product does not comply with Article 95 (2) in that period the prohibition in Article 95 (2) shall apply.

Article 95JTransitional measures active substance applications

1.

This Article applies to applications made before exit day under Article 7 of Regulation (EU) No 528/2012.

2.

Where the United Kingdom was the evaluating competent authority and has not concluded its evaluation of an application before exit day, the application is to be treated as if it were made under Article 7 of this Regulation and the time limits under Articles 7 and 8 shall be suspended until—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 90 days from exit day.

3.

On receipt of the resubmitted application and data to the competent authority, the time limits under Articles 7 and 8 shall apply less any time which expired between the date of acceptance of the application and data under Article 7 of Regulation (EU) No 528/2012 and exit day.

4.

Where the applicant does not meet the requirements of this Article, the application shall be rejected by the competent authority.

5.

Anything done before exit day by the United Kingdom as the evaluating competent authority under Regulation (EU) No 528/2012 is to be taken to have been done by the competent authority under this Regulation.

Article 95KTransitional measures application for renewal of an approval of an active substance

1.

This Article shall apply where an application for renewal of an approval of an active substance was made in accordance with Article 13 of Regulation (EU) No 528/2012.

2.

Where the United Kingdom was the evaluating competent authority and has not concluded its evaluation of an application before exit day, the application is to be treated as if it were made under Article 13 of this Regulation and the time limits under Articles 13 and 14 shall be suspended until—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 90 days from exit day.

3.

On receipt of the resubmitted application and data by the competent authority, the time limits under Articles 13 and 14 of this Regulation shall apply less any time which expired between the date of acceptance of the application and data under Article 13 Regulation (EU) No 528/2012 and exit day.

4.

Where the United Kingdom was not the evaluating competent authority and the evaluation of the application has not been concluded before exit day, the application is to be treated as if it were made under Article 13 of this Regulation and the time limits under Articles 13 and 14 shall be suspended until—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(b)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 180 days from exit day.

5.

Where the applicant does not meet the requirements of this Article, the approval shall not be renewed by the competent authority and Article 52 shall apply to any biocidal product containing the active substance.

6.

Anything done before exit day by the United Kingdom as the evaluating competent authority under Regulation (EU) No 528/2012 is to be taken to have been done by the competent authority under this Regulation.

Article 95LTransitional measures for ongoing applications to change or amend authorisations

1.

This Article applies to an application under 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.

2.

The application shall be treated as having been made under Regulation 354/2013 and the time limits under that Regulation shall be suspended until—

(a)

the date on which the applicant resubmits the application and any supporting data to the competent authority; or

(a)

where the applicant relies on a letter of access, whichever is the later of the date on which—

(i)

the applicant resubmits the application; and

(ii)

the data owner resubmits the data

in accordance with Article 71 of this Regulation, provided this date is within 180 days from exit day.

3.

Where the applicant does not meet the requirements of this Article, the application shall be rejected by the competent authority.

4.

For the purposes of this Article, data submitted by the applicant or the data owner shall include relevant data on the reference product.”