CHAPTER XVII

FINAL PROVISIONS

Fees and charges
Article 80. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The competent authority
Article 81
1
The competent authority responsible for the application of this Regulation—
a
is the competent authority as appointed by regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013, and
b
must have a sufficient number of suitably qualified and experienced staff to enable the obligations provided for in this Regulation to be carried out efficiently and effectively.
2
The competent authority shall provide advice to applicants, in particular to SMEs, and to any other interested parties on their respective responsibilities and obligations under this Regulation. That shall include the provision of advice about the possibility of adapting the data requirements of Articles 6 and 20, the grounds on which such an adaptation can be made, and on how to prepare a proposal. ...
The competent authority may in particular provide advice by establishing a helpdesk. Helpdesks already established under Regulation (EC) No 1907/2006 may act as helpdesks under this Regulation.
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Committee procedure
Article 82. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Exercise of the delegation
Article 83. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulation procedure
Article 83A
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.

The consent requirement
Article 83B
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 and 3.
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 1998) 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 2006) whether or not the exercise of the function also relates to a part of the United Kingdom other than Wales.

Urgency procedure
Article 84. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Adaptation to scientific and technical progress
Article 85
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.

Active substances included in Annex I to Directive 98/8/EC
Article 86
Active substances
included
in Annex I to Directive 98/8/EC shall be deemed to have been approved under this Regulation on the date of inclusion and shall be included in the list referred to in Article 9(2). Approval shall be subject to the conditions set out in those Commission directives.

Penalties
Article 87. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Safeguard clause
Article 88
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 5.
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).
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.
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 Authority and the Secretary of State giving reasons for the decision.

Existing transitional measures
Article 89
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.
Subject to paragraph 7A,
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.
7A
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, where paragraph 7B or 7C applies the current system or practice of making available on the market or using a biocidal product is to apply until the relevant date or, if earlier, the date on which the product is authorised under this Regulation. The competent authority may, in accordance with the current system or practice, authorise the making available on the market or use of the biocidal product.
7B
This paragraph applies to a biocidal product—
a
that contains at least one existing active substance that was approved before IP completion day; and
b
the application in respect of which—
i
is one to which a relevant provision applies;
ii
was received no later than the date of approval of the last of the active substances to be approved for that product-type; and
iii
was resubmitted by virtue of Article 95B, 95D, 95E, 95F, 95FA or 95H.
7C
This paragraph applies to a biocidal product—
a
that contains at least one active substance in respect of which the implementing regulation providing that the substance is approved entered into force before IP completion day;
b
to which paragraph 7B does not apply; and
c
the application in respect of which—
i
is one to which a relevant provision applies;
ii
was received no later than the date of approval of the last of the active substances to be approved for that product-type; and
iii
was received after IP completion day.
8.
By way of derogation from
paragraphs 7 and 7A
, 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
or, where paragraph 7A applies, before the relevant date
.
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.
9A
Where, in relation to a particular case the application in respect of which is one to which a relevant provision applies, the deadline by which a competent authority must authorise a biocidal product is extended under Article 26(4), Article 29(3) or Article 30(2A), the relevant date for the purposes of paragraphs 7A and 9 is to be extended by the same number of days in relation to that particular case.
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.
12
In this Article—
- “
implementing regulation
” has the same meaning as 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 as it had effect immediately before IP completion day;
- “
relevant date
” means—
  1. where Article 26(2A) applies, 29th April 2028;
  2. where Article 26(3A) or 30(1A) applies, 31st December 2027;
  3. where Article 29(1A) applies, 1st March 2029; or
  4. where Article 5(2) or 6A(1A) of Commission Implementing Regulation (EU) No 414/2013 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 Council applies, 31st December 2027;
- “
relevant provision
” means—
  1. Article 26(2A);
  2. Article 26(3A);
  3. Article 29(1A);
  4. Article 30(1A);
  5. Article 5(2) of Commission Implementing Regulation (EU) No 414/2013 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 Council; or
  6. Article 6A(1A) of that Regulation.

Transitional measures concerning active substances evaluated under Directive 98/8/EC
Article 90
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Applications submitted for the purposes of Directive 98/8/EC for which the ... evaluation in accordance with Article 11(2) of Directive 98/8/EC had not been completed by 1 September 2013 shall be evaluated by the competent authority in accordance with the provisions of this Regulation and, where relevant, Regulation (EC) No 1062/2014.
That evaluation shall be carried out on the basis of the information provided in the dossier submitted under Directive 98/8/EC.
Where the evaluation identifies concerns arising from the application of provisions of this Regulation which were not included in Directive 98/8/EC, the applicant shall be given the opportunity to provide additional information.
Every effort shall be made to avoid additional testing on vertebrates and to avoid causing delays to the review programme laid down in Regulation (EC) No 1062/2014 as a result of these transitional arrangements.
...

Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC
Article 91
Applications for biocidal product authorisations submitted for the purposes of Directive 98/8/EC for which the evaluation had not been completed by 1 September 2013 shall be evaluated by the competent authority in accordance with that Directive.
Notwithstanding the first paragraph, the following shall apply:
- where the risk assessment of the active substance indicates that one or more of the criteria listed under Article 5(1) is met, the biocidal product shall be authorised in accordance with Article 19,
- where the risk assessment of the active substance indicates that one or more of the criteria listed under Article 10 is met, the biocidal product shall be authorised in accordance with Article 23.
Where the evaluation identifies concerns arising from the application of provisions of this Regulation which were not included in Directive 98/8/EC, the applicant shall be given the opportunity to provide additional information.

Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC
Article 92
1
Biocidal products for which an authorisation or registration in accordance with Article 3, 4, 15 or 17 of Directive 98/8/EC was granted before 1 September 2013 can continue to be made available on the market and used subject, where applicable, to any conditions of authorisation or registration stipulated under that Directive until the expiry date of the authorisation or registration or its cancellation.
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.
2
Notwithstanding paragraph 1, this Regulation shall apply to biocidal products referred to in that paragraph from 1 September 2013.
Biocidal products authorised in accordance with Article 3 or 4 of Directive 98/8/EC shall be considered as authorised in accordance with Article 17 of this Regulation.

Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC
Article 93
By way of derogation from Article 17(1),
the
current system or practice of making available on the market and using a biocidal product not covered by the scope of Directive 98/8/EC, but falling within the scope of this Regulation, and consisting of, containing or generating only active substances that were available on the market, or used in biocidal products, on 1 September 2013
, shall continue to apply—
...
1. where applications for approval of all those active substances, which the biocidal product consists of, contains or generates,
were
submitted for the relevant product-type by 1 September 2016, the deadlines provided for in the second subparagraph
Article 89(7), in Article 89(8) to (10) and in Article 89(11); or
2. where an application
was
not submitted in accordance with point (a) for one of the active substances, until 1 September 2017.

Transitional measures concerning treated articles
Article 94
1
By way of derogation from Article 58(2), a treated article treated with or intentionally incorporating one or more biocidal products containing only active substances that are under examination for the relevant product-type in the work programme referred to in Article 89(1) on 1 September 2016 or for which an application for approval for the relevant product-type is submitted by that date, or containing only a combination of such substances and active substances included in the list drawn up in accordance with Article 9(2) for the relevant product-type and use or included in
the Simplified Active Substance List
, may be placed on the market until one of the following dates:
a
in the case of a decision adopted
by the Commission after 1 September 2016 but before IP completion day or issued by the Secretary of State after IP completion day
to reject the application for approval of, or not to approve, one of the active substances for the relevant use, the date falling 180 days after such a decision;
b
in other cases, the date of approval for the relevant product-type and use of the last active substance to be approved and contained in the biocidal product.
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transitional measures concerning access to the active substance dossier
Article 95
1
The competent authority
shall make publicly available and shall regularly update a list of all active substances, and all substances generating an active substance, for which a dossier complying with Annex II to this Regulation or with Annex IIA or IVA to Directive 98/8/EC and, where relevant, Annex IIIA to that Directive (‘the complete substance dossier’)
is
submitted and accepted or validated by
the competent authority
in a procedure provided for by this Regulation or that Directive (‘the relevant substances’). For each relevant substance, the list shall also include all persons having made such a submission or a submission to the
competent authority
in accordance with the second subparagraph of this paragraph, and indicate their role as specified in that subparagraph, and the product-type(s) for which they have made a submission, as well as the date of inclusion of the substance in the list.
A person established within the
United Kingdom
who manufactures or imports a relevant substance, on its own or in biocidal products (‘the substance supplier’) or who manufactures or makes available on the market a biocidal product consisting of, containing or generating that relevant substance (‘the product supplier’), may at any time submit to the
competent authority
either a complete substance dossier for that relevant substance, a
letter of access which provides the competent authority with access to a complete substance dossier
, or a reference to a complete substance dossier for which all data protection periods have expired. Following the renewal of the approval of an active substance, any substance supplier or product supplier may submit to the
competent authority
a letter of access to all the data which was considered by the
... competent authority as relevant for the purpose of the renewal, and for which the protection period has not yet expired (‘the relevant data’).
The
competent authority
shall inform the submitting supplier of the
appropriate fees
. It shall reject the application if the submitting supplier fails to pay those fees within 30 days and shall inform the submitting supplier accordingly.
Upon receipt of the
appropriate fees
, the
competent authority
shall verify whether the submission complies with the second subparagraph of this paragraph and shall inform the submitting supplier accordingly.
2
As of 1 September 2015, a biocidal product consisting of, containing or generating a relevant substance, included in the list referred to in paragraph 1, shall not be made available on the market unless either the substance supplier or the product supplier is included in the list referred to in paragraph 1 for the product-type(s) to which the product belongs.
3
For the purposes of making a submission in accordance with the second subparagraph of paragraph 1 of this article, Article 63(3) of this Regulation shall apply to all toxicological, ecotoxicological and environmental fate and behaviour studies relating to substances listed in Annex II to Regulation (EC) No 1451/2007, including any such studies not involving tests on vertebrates.
4
A substance supplier or a product supplier included in the list referred to in paragraph 1 to whom a letter of access has been issued for the purpose of this Article or a right to refer to a study has been granted in accordance with paragraph 3 shall be entitled to allow applicants for the authorisation of a biocidal product to make reference to that letter of access or that study for the purposes of Article 20(1)
, where that letter of access gives the competent authority direct access to the information, and where the competent authority holds the relevant data
.
5
By way of derogation from Article 60, all data protection periods for active substance/product-type combinations listed in Annex II to Regulation (EC) No 1451/2007, but for which a decision on inclusion in Annex I to Directive 98/8/EC was not taken before 1 September 2013, shall end on 31 December 2025.
6
Paragraphs 1 to 5 shall not apply to substances listed in
the Simplified Active Substance List
in
categories A and C
or to biocidal products containing only such substances.
7
The
competent authority
shall regularly update the list referred to in paragraph 1 of this Article. Following the renewal of the approval of an active substance, the
competent authority
shall remove from the list any substance supplier or product supplier who has not, within 12 months of the renewal, submitted all the relevant data or a letter of access to all the relevant data, either in accordance with the second subparagraph of paragraph 1 of this Article or in an application in accordance with Article 13.
8
The competent authority may refuse to accept a letter of access for the purposes of this Article if they do not hold the relevant data.

Transitional measures for simplified notification procedure
Article 95A
1
Where, before IP completion day, a product was authorised in a country which was a Member State of the EU other than the United Kingdom in accordance with Article 26 of Regulation (EU) No 528/2012, and was 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 must grant an authorisation under Article 26 of this Regulation.
2
The authorisation must be cancelled and Article 52 of this Regulation will apply where—
a
the authorisation holder is not established in the United Kingdom within 12 months from IP completion day, or
b
the authorisation holder does not supply the competent authority with relevant scientific and authorisation data by whichever is the earlier of the following—
i
the date of any application for renewal or the date of any application for amendment of 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.

Transitional measures for mutual recognition applications
Article 95B
1
This Article applies where—
a
an application for mutual recognition of a national authorisation of a biocidal product was made before IP completion day in accordance with Articles 33, 34 or 39 of Regulation (EU) No 528/2012, and
b
a decision was not made before IP completion 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 is to be treated as having been made under Article 29 of this Regulation, and the time limits under Articles 29 and 30 are 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 following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
4
On receipt of the resubmitted application and data to the competent authority, the time limits under Articles 29 and 30 of this Regulation 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.
4A
But paragraph 4 does not apply so as to shorten—
a
the deadline in paragraph 1 of Article 29, as it is modified by paragraph 1A of that Article; or
b
the deadlines in paragraphs 1A, 2A and 4 of Article 30.
5
Paragraphs 6, 7 and 8 apply where, before IP completion day, the United Kingdom was 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 is to be treated as having been made under Article 29 of this Regulation, and the time limits under Articles 29 and 30 apply from—
a
the date on which the applicant resubmits the application and any supporting data to the competent authority, or
b
where the application relies on a letter of access, whichever is the later of the following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
7
Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).
8
Anything done before IP completion day by the United Kingdom competent authority, where the United Kingdom was either the Member State concerned or the reference Member State, is taken as having been done by the competent authority under this Regulation.
9
The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.
10
The resubmission of any application and data referred to in paragraph 6 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Renewal of authorisations subject to mutual recognition under Regulation 492/2014
Article 95C
1
This Article applies where—
a
an application for the renewal of a biocidal product authorisation subject to mutual recognition was made before IP completion day in accordance with Article 3 of Commission Delegated Regulation (EU) No 492/2014 of 7 March 2014 supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the rules for renewal of authorisations of biocidal products subject to mutual recognition, and
b
a decision on the renewal of the authorisation was not made before IP completion day.
2
Paragraph 3 applies where, before exit day, the United Kingdom was the reference Member State for an application for renewal.
3
The application is to be treated as having been made under Article 31 of this Regulation and the time limits under Article 31 are 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 following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
4
On receipt of the resubmitted application and data by the competent authority, the time limits under Articles 30 and 31 (where applicable) of this Regulation 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 492/2014 and exit day.
4A
But paragraph 4 does not apply so as to shorten the deadlines in paragraphs 1A, 2A and 4 of Article 30.
5
Paragraph 6 applies where, before IP completion day, the United Kingdom was the Member State concerned for an application for renewal.
6
The application is to be treated as having been made under Article 31 of this Regulation, and the time limits under Articles 30 and 31 apply 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 following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
7
Anything done before IP completion day by the United Kingdom, either as the Member State concerned or as the reference Member State, is taken as having been done by the competent authority under this Regulation.
8
The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.
9
The resubmission of any application and data referred to in paragraph 6 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.
10
Where the applicant or authorisation holder does not meet the requirements of this Article—
a
the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9), and
b
the authorisation must be cancelled by the competent authority and Article 52 applies.

Transitional measure for national authorisation applications
Article 95D
1
This Article applies where—
a
an application was made before IP completion day to the United Kingdom competent authority under Articles 29 or 31 of Regulation (EU) No 528/2012, and
b
a decision was not made before IP completion day.
2
The application is to be treated as having been made under this Regulation and the time limits under Articles 29, 30 and 31 as appropriate apply 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 following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
3
Where the applicant or authorisation holder does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).
4
Anything done before IP completion day by the United Kingdom competent authority as the receiving competent authority is taken as having been done by the competent authority under this Regulation.
5
The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.

Transitional measures simplified authorisation applications
Article 95E
1
This Article applies where—
a
an application was made to the United Kingdom competent authority before IP completion day under Articles 25 or 26 of Regulation (EU) No 528/2012, and
b
a decision was not made before IP completion day.
2
Where the application was made to the United Kingdom competent authority as the receiving competent authority, the application is to be treated as having been made under this Regulation and the time limits under Article 26 apply 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 following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
3
In a case where an application was made but the United Kingdom competent authority was not the receiving competent authority, the application is to be treated as having been made under this Regulation and the time limits under Article 26 apply 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 following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
4
Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).
5
Anything done before IP completion day by the United Kingdom competent authority as the receiving competent authority is taken as having been done by the competent authority under this Regulation.
6
The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.
7
The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Transitional measures for applications for same biocidal product authorisations
Article 95F
1
This Article applies where—
a
an application was made to the United Kingdom competent authority before IP completion day under Articles 3 or 4 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 Council, and
b
a decision was not made before IP completion day.
2
The application is to be treated as having been made under Articles 3 or 4 (as appropriate) of Regulation (EU) No 414/2013 and the time limits under those Articles are apply 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 following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
3
Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies 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 must include relevant data for the reference product.
5
The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Transitional measures for applications for same biocidal product authorisations under the simplified procedure
Article 95FA
1
This Article applies where—
a
an application was made to the United Kingdom competent authority before IP completion day under Article 4a of Commission Implementing Regulation (EU) No 414/2013 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 Council; and
b
a decision was not made before IP completion day.
2
The application is to be treated as having been made under Article 4a of Regulation (EU) 414/2013.
3
The applicant must—
a
resubmit the application and any supporting data to the competent authority; or
b
where the applicant relies on a letter of access—
i
resubmit the application; and
ii
ensure that the data owner resubmits the data.
4
Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).
5
For the purposes of this Article, data resubmitted by the applicant or the data owner must include relevant data for the reference product.
6
The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 before 31 January 2023.

Transitional measures for Regulation (EU) No 528/2012 authorisations
Article 95G
1
This Article applies to authorisations granted by the United Kingdom competent authority before IP completion 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 must be cancelled and Article 52 of this Regulation will apply where—
a
the authorisation holder is not established in the United Kingdom within 12 months after IP completion day, or
b
the authorisation holder does not supply the competent authority with relevant scientific and authorisation data by whichever is the earlier of the following—
i
the date of any application for renewal or for amendment of 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.

Transitional measures for ongoing applications for Union authorisations
Article 95H
1
This Article applies where—
a
an application for Union authorisation was made before IP completion day in accordance with Articles 42, 43 or 45 of Regulation (EU) No 528/2012, and
b
a decision was not made before IP completion day.
2
Paragraph 3 applies where, before IP completion day, the United Kingdom competent authority was the evaluating competent authority for applications for Union authorisations made under Regulation (EU) No 528/2012.
3
The application is to be treated as being made under Articles 29 or 31 of this Regulation and the time limits under Articles 29, 30 or 31 are 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 following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
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 apply less any time which expired between the date of acceptance of the application and data under Articles 43, 44, 45 or 46 of Regulation (EU) No 528/2012 and exit day.
4A
But paragraph 4 does not apply so as to shorten—
a
the deadline in paragraph 1 of Article 29, as it is modified by paragraph 1A of that Article; or
b
the deadlines in paragraphs 1A, 2A and 4 of Article 30.
5
Paragraph 6 applies to those ongoing Union authorisation applications made under Regulation (EU) No 528/2012 where the United Kingdom competent authority was not the evaluating competent authority.
6
The application is to be treated as having been made under Articles 29, 30 or 31 of this Regulation, and the time limits under those Articles apply from—
a
the date on which the applicant resubmits the application and any supporting data to the competent authority, or
b
where the application relies on a letter of access, whichever is the later of the following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
7
Where the applicant or authorisation holder does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).
8
Anything done before IP completion day by the United Kingdom competent authority as the evaluating competent authority is taken as having been done by the competent authority under this Regulation.
9
The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.
10
The resubmission of any application and data referred to in paragraph 6 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Transitional measures for Article 95 List
Article 95I
1
This Article applies to the list prepared pursuant to Article 95 of Regulation (EU) No 528/2012 (“the Article 95 pre-IP completion day List”) of active substances and persons having made submissions in relation to those active substances.
2
Subject to paragraph 3, from IP completion day the entries included in the Article 95 pre-IP completion day List are to be included in the list prepared pursuant to Article 95 of this Regulation (“the Article 95 List”).
3
An entry on the Article 95 List must be removed if either of the following conditions are not met within 2 years from IP completion day—
a
the person must be established in the United Kingdom;
b
the person must provide to the competent authority any of the following—
i
a complete dossier for the relevant active substance;
ii
a reference to a complete active 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 a complete active substance dossier, where that dossier has been submitted to the competent authority within 2 years of IP completion 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.
5
A period of grace in excess of 180 days may only be granted under paragraph 4 in exceptional circumstances.
6
Where a period of grace is granted in accordance with paragraph 4, and the supplier of a biocidal product does not comply with the second subparagraph of Article 95(1) during that period, the prohibition in Article 95(2) applies.

Transitional measure for active substance applications made to the United Kingdom competent authority before 30 March 2019 and subsequently reallocated
Article 95J
1
This Article applies where—
a
an application was made to the United Kingdom competent authority as evaluating competent authority before 30 March 2019 under Article 7 of Regulation (EU) No 528/2012,
b
the competent authority had not completed its evaluation of the application before IP completion day due to the evaluation being reallocated at EU level, and
c
a decision was not made before IP completion day.
2
An application referred to in paragraph 1 is to be treated as if it were made under Article 7 of this Regulation, and the time limits in Articles 7 and 8 are suspended until—
a
the date on which the applicant resubmits the application and any supporting data to the competent authority, or
b
where the application relies on a letter of access, whichever is the later of the following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
3
On receipt of the resubmitted application and data by the competent authority, the time limits under Articles 7 and 8 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—
a
30 March 2019 for active substances listed in the Annex to Commission Delegated Regulation (EU) 2019/227, or
b
exit day for other substances.
4
Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority.
5
Anything done before exit day by the competent authority as the evaluating competent authority under Regulation (EU) No 528/2012 is taken as having been done by the competent authority under this Regulation.
6
The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.

Transitional measure for active substance applications made before IP completion day pursuant to Article 93 where the United Kingdom competent authority was not the evaluating competent authority
Article 95K
1
This Article applies where—
a
an application to approve an active substance was made before IP completion day under Article 7 of Regulation (EU) No 528/2012 and in compliance with point (a) of Article 93,
b
the United Kingdom competent authority was not the evaluating competent authority, and
c
a decision was not made before IP completion day.
2
An application referred to in paragraph 1 is to be treated as if it were made under Article 7 of this Regulation, and the time limits under Articles 7 and 8 apply from—
a
the date on which the applicant resubmits the application and any supporting data to the competent authority, or
b
where the application relies on a letter of access, whichever is the later of the following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
3
Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority.
4
The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Transitional measures for renewal of an approval of an active substance
Article 95L
1
This Article applies where—
a
an application for renewal of an approval of an active substance was made before IP completion day in accordance with Article 13 of Regulation (EU) No 528/2012, and
b
a decision was not made before IP completion day.
2
Where the United Kingdom competent authority was the evaluating competent authority 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 are suspended until—
a
the date on which the applicant resubmits the application and any supporting data to the competent authority, or
b
where the application relies on a letter of access, whichever is the later of the following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
3
On receipt of the resubmitted application and data by the competent authority, the time limits under Articles 13 and 14 of this Regulation apply less any time which expired between the date of acceptance of the application and data under Article 13 and 30 March 2019.
4
Where the United Kingdom competent authority was not the evaluating competent authority 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 apply from—
a
the date on which the applicant resubmits the application and any supporting data to the competent authority, or
b
where the application relies on a letter of access, whichever is the later of the following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
5
Where the applicant does not meet the requirements of this Article, the approval must not be renewed by the competent authority and Article 52 applies to any biocidal product containing the active substance.
6
Anything done before IP completion day by the United Kingdom competent authority as the evaluating competent authority under Regulation (EU) No 528/2012 is taken as having been done by the competent authority under this Regulation.
7
The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.
8
The resubmission of any application and data referred to in paragraph 4 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Transitional measures for ongoing applications to change or amend authorisations
Article 95M
1
This Article applies where—
a
an application was made before IP completion day to the United Kingdom competent authority 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, and
b
a decision was not made before IP completion day.
2
An application referred to in paragraph 1 is to be treated as having been made under Regulation (EU) No 354/2013 and the time limits under that Regulation apply from—
a
the date on which the applicant resubmits the application and any supporting data to the competent authority, or
b
where the application relies on a letter of access, whichever is the later of the following—
i
the applicant resubmits the application, or
ii
the data owner resubmits the data.
3
Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority.
4
For the purposes of this Article, data submitted by the applicant or the data owner for changes to authorisations issued under Commission Implementing Regulation (EU) No 414/2013 must include relevant data on the reference product.
5
The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Interpretation of Articles 95A to 95M
Article 95N
1
For the purposes of Articles 95A to 95M, the following definitions apply—
- “evaluating competent authority” has the meaning given in Article 7 of Regulation (EU) No 528/2012 as it had effect immediately before IP completion day;
- “Member State concerned” has the meaning given in Articles 33 and 34 of Regulation (EU) No 528/2012 as it had effect immediately before IP completion day;
- “receiving competent authority” has the meaning given in Article 17 of Regulation (EU) No 528/2012 as it had effect immediately before IP completion day;
- “reference Member State” has the meaning given in Articles 33 and 34 of Regulation (EU) No 528/2012 as it had effect immediately before IP completion day.

Repeal
Article 96
Without prejudice to Articles 86, 89 to 93 and 95 of this Regulation, Directive 98/8/EC is hereby repealed with effect from 1 September 2013.
References to the repealed Directive shall be construed as references to this Regulation and read in accordance with the correlation table in Annex VII.

Entry into force
Article 97. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Substituted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).
Inserted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).
Arts. 83A, 83B 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. 125 (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 35); 2020 c. 1, Sch. 5 para. 1(1)
Arts. 95A-95N inserted (31.12.2020) by S.I. 2019/720, Sch. 4 para. 2 (as inserted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 4)
Art. 80 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. 122; 2020 c. 1, Sch. 5 para. 1(1)
Art. 81 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. 123(2); 2020 c. 1, Sch. 5 para. 1(1)
Art. 81(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. 123(3) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 34); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 81(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. 123(4)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 81(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. 123(4)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 81(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. 123(4)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 81(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. 123(4)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Art. 81(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. 123(4)(c); 2020 c. 1, Sch. 5 para. 1(1)
Art. 82 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. 124; 2020 c. 1, Sch. 5 para. 1(1)
Art. 83 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. 124; 2020 c. 1, Sch. 5 para. 1(1)
Art. 84 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. 124; 2020 c. 1, Sch. 5 para. 1(1)
Art. 85 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. 126; 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 86 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. 127; 2020 c. 1, Sch. 5 para. 1(1)
Art. 87 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. 128; 2020 c. 1, Sch. 5 para. 1(1)
Art. 88 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. 129 (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 36); 2020 c. 1, Sch. 5 para. 1(1)
Art. 89 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. 130; 2020 c. 1, Sch. 5 para. 1(1)
Art. 90(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. 131(2); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 90(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. 131(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 90(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. 131(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 90(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. 131(3)(c); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 90(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. 131(3)(d); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 90(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. 131(3)(e); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 91 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. 132(a); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 91 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. 132(b); 2020 c. 1, Sch. 5 para. 1(1)
Art. 92(1A)-(1C) 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. 133; 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 93 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. 134(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 93 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. 134(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 93 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. 134(2)(c); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 93(a) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 134(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 93(a) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 134(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 93(b) 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. 134(4); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 94(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. 135(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 94(1)(a) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 135(2)(b) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 37); 2020 c. 1, Sch. 5 para. 1(1)
Art. 94(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. 135(3); 2020 c. 1, Sch. 5 para. 1(1)
Art. 95(8) 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. 136(6); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 95(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. 136(2)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 95(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. 136(2)(b)(iv); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(d)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(3); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(6) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 136(4); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(6) substituted (31.12.2020 immediately before IP completion day) by S.I. 2019/720, Sch. 4 para. 4(2) (as inserted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 4)
Words in Art. 95(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. 136(5); 2020 c. 1, Sch. 5 para. 1(1)
Art. 97 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. 138; 2020 c. 1, Sch. 5 para. 1(1)
Art. 95FA inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(8)
Art. 89(7A)-(7C) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(5)(b)
Art. 89(9A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(5)(e)
Art. 89(12) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(5)(f)
Words in Art. 89(7) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(5)(a)
Words in Art. 89(8) substituted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(5)(c)
Words in Art. 89(9) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(5)(d)
Art. 95B(4A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(6)
Art. 95C(4A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(7)
Art. 95H(4A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(9)