The Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013

Regulation 14(4)

SCHEDULE 1 Biocidal products appeals

PART 1 DEFINITIONS AND ARRANGEMENTS FOR AN APPEAL

1.  In this Schedule—

(a) “appeal” means an appeal under regulation 14;

“appellant” means a person who has brought an appeal;

“appointed person” means a person appointed in accordance with paragraph 2;

“appropriate person” has the same meaning as it has in regulation 14(8);

“hearing” means a hearing to which Part 2 of this Schedule applies;

“the parties” means the appellant and the competent authority;

(b)

a reference to “government department” includes, in the case of an appeal relating to a decision of the competent authority—

(i)

in or as regards Scotland, a reference to the Scottish Administration or any part thereof; and

(ii)

in or as regards Wales, a reference to the Welsh Ministers;

(c)

a reference to a numbered sub-paragraph is a reference to the sub-paragraph so numbered in the paragraph in which that reference occurs.

2.  The appropriate person must—

(a) direct that an appeal shall be determined by a person appointed by the appropriate person for that purpose; and

(b) notify the parties in writing of the name of the appointed person.

3.  Before the determination of an appeal, the appointed person must ask the parties whether they wish to appear and be heard on the appeal and—

(a) the appeal may be determined without a hearing if the parties express a wish not to be heard;

(b) the appointed person must, if either of the parties expresses a wish to appear and be heard, afford both of them an opportunity of so doing, in which case the provisions of Part 2 of this Schedule shall apply.

4.  An appointed person may give such directions as that appointed person thinks appropriate to give effect to a determination.

5.  The appropriate person may pay to an appointed person such remuneration and allowances as the appropriate person may determine.

PART 2 APPEAL PROCEDURES

6.  An appeal brought pursuant to regulation 14(1)(q) must be heard in private.

7.—(1) Subject to the following sub-paragraphs of this paragraph, a date, time and place for the holding of the hearing shall be fixed, and may be varied, by the appointed person, who must give not less than 42 days’ notice in writing of such date, time and place to the parties.

(2) With the consent of the parties, the appointed person may give such lesser period of notice as shall be agreed with the parties, and in that event, the appointed person may specify a date for service of the statement referred to in paragraph 8(1) later than the date determined in accordance with that paragraph.

(3) Where it becomes necessary or advisable to vary the time or place fixed for the hearing, the appointed person shall give such notice of the variation as may appear to the appointed person to be reasonable in the circumstances.

(4) Without prejudice to sub-paragraphs (1) to (3), the appointed person may require the competent authority to take one or more of the following steps, namely—

(a) to serve such notice of the hearing, in such form and on such persons or classes of persons as the appointed person may direct;

(b) to give such other notice of the hearing, in such form as the appointed person may direct,

and the requirements as to the period of notice contained in sub-paragraph (1) shall not apply to any such notices.

8.—(1) Not later than 28 days before the date of the hearing, or such later date as the appointed person may specify in accordance with paragraph 7(2), the competent authority must serve on the appellant a written statement of any submission which the competent authority proposes to put forward at the hearing and shall supply a copy of the statement to the appointed person.

(2) Where a government department has expressed in writing to the competent authority a view in support of the decision of the competent authority and the competent authority proposes to rely on such expression of view in its submission at the hearing, the competent authority must include the expression of view in its statement and must supply a copy of the statement to the government department concerned.

(3) Where the competent authority intends to refer to, or put in evidence at the hearing, documents (including photographs), the statement of the competent authority must be accompanied by a list of such documents, together with a written notice stating the times and place at which the documents may be inspected by the appellant; and the competent authority shall afford the appellant a reasonable opportunity to inspect and, where practicable, to take copies of the documents.

(4) If so required by the appointed person, the appellant must—

(a) serve on the competent authority and on the appointed person, within such time before the hearing as the appointed person may specify, a written statement of the submissions which the appellant proposes to put forward at the hearing; and such statement must be accompanied by a list of any documents (including photographs) which the appellant intends to refer to or put in evidence at the hearing; and

(b) afford the competent authority a reasonable opportunity to inspect and, where practicable, to take copies of such documents as are referred to in paragraph (a).

9.—(1) The parties shall be entitled to appear at the hearing.

(2) Any other person may appear at the discretion of the appointed person provided that that person has, not later than 7 days before the date of the hearing, served on the competent authority a statement of that person’s proposed submissions.

(3) The competent authority must send a copy of every statement served on the competent authority in accordance with sub-paragraph (2) to the appointed person and to the appellant.

(4) A body corporate may appear by its clerk or secretary or by any other officer appointed for the purpose by that body, or by counsel or a solicitor.

(5) A Scottish partnership (other than a limited liability partnership), may appear by a partner or other person in charge, or locally in charge, of the partnership’s affairs.

(6) A person may appear on that person’s own behalf or be represented by counsel, a solicitor or any other person.

(7) Where there are two or more persons having a similar interest in the subject matter of the hearing, the appointed person may allow one or more persons to appear for the benefit of some or all persons so interested.

10.—(1) Where a government department has expressed in writing to the competent authority a view in support of the decision of the competent authority and the competent authority has included this view in the statement referred to in paragraph 8(1), the appellant may apply in writing to the appointed person, not later than 14 days before the date of the hearing, for a representative of the government department concerned to be made available at the hearing.

(2) The appointed person must send an application made to the appointed person under sub-paragraph (1) to the government department concerned, who must make a representative of the department available to attend the hearing.

(3) A representative of a government department who, in pursuance of this paragraph, attends a hearing, shall be called as a witness by the competent authority and shall state the reasons for the view expressed by the representative’s department and included in the statement of the competent authority under paragraph 8(1) and shall give evidence and be subject to cross-examination to the same extent as any other witness.

(4) Nothing in sub-paragraph (3) shall require a representative of a government department to answer any question which, in the opinion of the appointed person, is directed to the merits of government policy or to matters which affect the safety of the State, and the appointed person must disallow any such question.

11.—(1) Except as otherwise provided in this Part of this Schedule, the procedure at the hearing must—

(a) be determined at the discretion of the appointed person, subject to consideration of any submission by the parties at the commencement of the hearing; and

(b) be communicated by the appointed person to the parties at the commencement of the hearing.

(2) Unless in any particular case the appointed person, with the consent of the appellant, otherwise determines—

(a) in the case of an appeal to the Secretary of State, the appellant shall be heard first and shall have the right of final reply; and

(b) in the case of an appeal to the Secretary of State and the Scottish Ministers, or the Secretary of State and the Welsh Ministers, acting jointly—

(i) the appellant shall be heard first;

(ii) the other persons entitled or permitted to appear shall be heard in such order as the appointed person may determine; and

(iii) any closing statements shall be made in the same order, unless the appointed person otherwise determines.

(3) The parties shall be entitled to make an opening statement, to call evidence and to cross-examine persons giving evidence, but any other person appearing at the hearing may do so only to the extent permitted by the appointed person.

(4) Subject to sub-paragraph (5), any evidence may be admitted at the discretion of the appointed person, who may direct that documents tendered in evidence may be inspected by any person entitled or permitted to appear at the hearing and that facilities be afforded to that person to take or obtain copies of those documents.

(5) The appointed person shall not require or permit the giving or production of any evidence, whether written or oral, which would be contrary to the public interest.

(6) The appointed person may allow the competent authority or the appellant, or the parties, to alter or add to the submissions contained in any statement served under paragraph 8(1) or (4), or to any list of documents which accompanied such statement, so far as may be necessary for the purpose of determining the questions in controversy between the parties, but must (if necessary by adjourning the hearing) give the appellant or the competent authority, as the case may be, an adequate opportunity of considering any such fresh submission or document.

(7) If any person entitled to appear at the hearing fails to appear, the appointed person may proceed with the hearing at the appointed person’s discretion.

(8) The appointed person shall be entitled to take into account any written representations or statements received by the appointed person before the hearing from any person, subject to disclosure of such representations or statements at the hearing.

(9) The appointed person may from time to time adjourn the hearing, and where the appointed person does so, shall give reasonable notice to every person entitled or permitted to appear at the hearing of the date, time and place of the adjourned hearing.

12.—(1) Where, after the close of the hearing, the appointed person proposes to take into consideration—

(a) any new evidence, including expert opinion on a matter of fact; or

(b) any new issue of fact, not being a matter of government policy or a matter affecting the safety of the State,

which was not raised at the hearing and which the appointed person considers to be material to the decision, the appointed person must not come to a decision without first notifying the parties of the substance of the new evidence or of the new issue of fact and affording them an opportunity of making representations on the new evidence or new issue in writing within 21 days or of asking within that time for the re-opening of the hearing.

(2) If the appointed person thinks fit, the appointed person may cause the hearing to be re-opened and must cause it to be re-opened if asked to do so in accordance with sub-paragraph (1).

(3) Where the hearing is re-opened, paragraphs 7(1) and 7(4) apply as they applied to the original hearing with the substitution in paragraph 7(1) of “28” for “42”.

13.  The appointed person must notify the determination on the appeal, and the reasons for the determination, in writing to the parties and to any person who, having appeared at the hearing, has asked to be notified of the decision.

Regulation 16

SCHEDULE 2 Transitional, transitory and savings provisions

1.  In this Schedule—

“COPR” means the Control of Pesticides Regulations 1986(1);

“COPR biocidal product” means any substance, preparation or organism prepared or used for any of the purposes listed in regulation 3(1) of COPR, which is not a plant protection product;

“Plant protection product” has the same meaning as in Article 2(1) of Regulation (EC) No 1107/2009(2) of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC;

“Unlisted active substance” means an existing active substance which has not been subject to a decision to approve or not approve it in accordance with Article 9 of the Biocides Regulation.

2.—(1) Following a decision that an unlisted active substance shall be approved in accordance with Article 9(1)(a) of the Biocides Regulation, COPR shall cease to apply to a COPR biocidal product containing that active substance on the dates determined in accordance with paragraphs 4 to 6.

(2) Where there is more than one unlisted active substance in a COPR biocidal product, the decision in sub-paragraph (1) shall be taken to mean the decision in relation to the last of the unlisted active substances in the COPR biocidal product.

3.  Following a decision that an unlisted active substance shall not be approved in accordance with Article 9(1)(b) of the Biocides Regulation, COPR shall cease to apply to a COPR biocidal product containing that active substance from the date or dates upon which the biocidal product may no longer be placed on the market or used pursuant to that decision.

4.—(1) Where—

(a) there is a decision referred to in paragraph 2; and

(b) no application is submitted in accordance with the Biocides Regulation for authorisation or mutual recognition in parallel in respect of the COPR biocidal product on or before the date of approval of the active substance,

COPR shall cease to apply to the COPR biocidal product in accordance with sub-paragraph (2).

(2) For the purposes of sub-paragraph (1), COPR shall cease to apply to the COPR biocidal product at the expiry of—

(a) 180 days from the date of approval, in relation to the placing on the market of the biocidal product; and

(b) 365 days from the date of approval, in relation to the disposal and use of existing stocks of the biocidal product.

5.—(1) Where—

(a) there is a decision referred to in paragraph 2; and

(b) an application is submitted in accordance with the Biocides Regulation for authorisation or mutual recognition in parallel of the COPR biocidal product on or before the date of approval of the active substance,

COPR shall cease to apply to the COPR biocidal product in accordance with sub-paragraphs (2) to (4).

(2) Where a decision is taken to authorise the COPR biocidal product, COPR shall cease to apply to the biocidal product from the date of that decision.

(3) Where the application referred to in sub-paragraph (1)(b) is rejected, COPR shall cease to apply to the COPR biocidal product at the expiry of—

(a) 180 days from the date of the decision to reject the application, in relation to the placing on the market of the biocidal product; and

(b) 365 days from the date of the decision to reject the application, in relation to the disposal and use of existing stocks of the biocidal product.

(4) Where a decision is taken not to authorise the COPR biocidal product, COPR shall cease to apply to the COPR biocidal product at the expiry of—

(a) 180 days from the date of that decision in relation to the placing on the market of the biocidal product; and

(b) 365 days from the date of that decision in relation to the disposal and use of existing stocks of the biocidal product.

6.—(1) Following an application for authorisation under the Biocides Regulation on or before 1st September 2017 in respect of a COPR biocidal product which falls within Article 93(1) of the Biocides Regulation, COPR ceases to apply to that biocidal product in accordance with sub-paragraphs (2) to (5).

(2) Where a decision is taken to authorise the COPR biocidal product, COPR shall cease to apply to the biocidal product from the date of that decision.

(3) Where the application referred to in sub-paragraph (1) is rejected, COPR shall cease to apply to the COPR biocidal product from the date of rejection.

(4) Where a decision is taken not to authorise the COPR biocidal product, COPR shall cease to apply to the biocidal product at the expiry of—

(a) 180 days from the date of that decision in relation to the placing on the market of the biocidal product; and

(b) 365 days from the date of the decision or 1st September 2018 (whichever is the later) in relation to the disposal and use of existing stocks of the biocidal product.

(5) Where no application for authorisation of the COPR biocidal product has been made by 1st September 2017, COPR shall cease to apply to the biocidal product after—

(a) 28th February 2018 in relation to the making available of the biocidal product on the market; and

(b) 1st September 2018 in relation to the disposal and use of existing stocks of the biocidal product.

7.  Despite the revocation of the Biocidal Products Regulations 2001 by virtue of regulation 34(a) of these Regulations, paragraph 13 of Schedule 13 to the Biocidal Products Regulations 2001 is preserved so that COPR shall continue not to apply to COPR biocidal products where, by virtue of that paragraph, it previously ceased to apply.

8.—(1) Where a certificate of exemption—

(a) was issued under paragraphs 6 to 12 of Schedule 13 to the Biocidal Products Regulations 2001; and

(b) has not expired or been revoked prior to 1st September 2013,

that certificate is hereby revoked.

(2) Where a certificate is revoked pursuant to sub-paragraph (1), the competent authority may issue a new certificate of exemption which exempts any person or class of person or any biocidal product or class of biocidal product from Article 17(1) of the Biocides Regulation.

9.  A certificate of exemption granted pursuant to paragraph 8(2)—

(a) must be in writing;

(b) must be granted for a period of time not exceeding the time period allowed for the continuation of the current system or practice, including any phase out period, allowed for under Article 89 of the Biocides Regulation;

(c) may be granted subject to conditions; and

(d) may be revoked by certificate in writing at any time.

10.—(1) Despite the revocation of the Biocidal Products Regulations 2001, the Biocidal Products (Amendment) Regulations 2007 and the Biocidal Products (Amendment) Regulations 2010 by virtue of regulation 34(a), (d) and (e) of these Regulations, the regulations listed in sub-paragraph (2) shall continue to apply for the purposes of evaluating applications for biocidal product authorisations pursuant to regulation 15(1) of these Regulations.

(2) The regulations referred to in sub-paragraph (1) are—

(a) Regulations 2, 3, 9, 10, 11, 12 ,13, 14, 15, 17, 18, 25, 32, 34, 35 and 37 of, and Schedules 3,4, and 5 to, the Biocidal Products Regulations 2001;

(b) Regulations 2, 3, 4, 8, 9, 10,11 and 21 of the Biocidal Products (Amendment) Regulations 2007; and

(c) Regulations 3 and 4 of the Biocidal Products (Amendment) Regulations 2010.

Regulation 30(2)

SCHEDULE 3 Defence Exemption Certificates

1.  The Secretary of State may decide that it is necessary in the interests of defence for a person to be exempt from compliance with a requirement or prohibition in the Biocides Regulation or the CLP Regulation.

2.  The Secretary of State may decide to apply the exemption—

(a) to a person, including the Secretary of State, or a category of persons;

(b) to one or more requirement or prohibition at the same time;

(c) prospectively;

(d) for a limited or unlimited period;

(e) generally or to a particular case;

(f) subject to such limitations and conditions as the Secretary of State sees fit.

3.  A decision by the Secretary of State to apply the exemption must be evidenced in writing by a certificate.

4.  A certificate—

(a) must contain sufficient particulars of the persons to whom, and the matters to which, it relates; and

(b) may be varied or revoked in writing.

5.  The Secretary of State may provide to a person who has the benefit of a certificate—

(a) the certificate;

(b) a copy of it; or

(c) a copy of a relevant extract of the certificate.

6.  A person who claims the benefit of a certificate must produce to the person listed in paragraph 7, when reasonably requested to do so—

(a) the certificate;

(b) a copy of it made by the Secretary of State; or

(c) a copy made by the Secretary of State of a relevant extract of the certificate.

7.  The persons referred to in paragraph 6 are—

(a) an enforcing authority;

(b) a competent authority;

(c) the equivalent of an enforcing authority of another Member State;

(d) the European Chemicals Agency.

8.  Unless the contrary is proved—

(a) a certificate;

(b) a copy of it made by the Secretary of State; or

(c) a copy made by the Secretary of State of a relevant extract of the certificate,

is conclusive evidence of the matters to which it relates.

9.  A person who fails to comply with paragraph 6 shall not be exempt from compliance with a requirement or prohibition in the Biocides Regulation or the CLP Regulation in the interests of defence.

Regulation 35

SCHEDULE 4 Amendments to the Chemicals (Hazard Information and Packaging for Supply) Regulations 2009

PART 1 References to Regulation (EU) No 649/2012

1.  In paragraph (ii) of the Preamble, for “Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals, of which Annexes I and V are as amended from time to time”, substitute “Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals, of which Annexes I, II, V and VI are as amended from time to time”.

2.  In regulation 3(3)(c), for “Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals, of which Annexes I and V are as amended from time to time”, substitute “Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals, of which Annexes I,II,V and VI are as amended from time to time”.

PART 2 Advertisements for dangerous preparations and penalties

3.  After regulation 5 insert—

“Advertisements for dangerous preparations

5A.— (1) Subject to paragraph (2), a person who supplies a dangerous preparation shall not advertise that preparation, or arrange for the production of any such advertisement, unless mention is made in the advertisement of the type of hazard indicated on the label.

(2) Paragraph (1) shall apply only in respect of a dangerous preparation where the advertisement enables a person, otherwise than in the course of a business, to conclude a contract to purchase the dangerous preparation before that person has seen the label relating to the dangerous preparation.

(3) In this regulation, “supply” has the same meaning as it has in section 46 of the Consumer Protection Act 1987.”.

4.  After regulation 14(1) insert—

“(1A) The maximum penalty for an offence under this regulation is—

(a) on summary conviction—

(i) in England and Wales, imprisonment for a term not exceeding three months or a fine not exceeding the statutory maximum, or both;

(ii) in Scotland, imprisonment for a term not exceeding twelve months or a fine not exceeding the statutory maximum, or both; and

(b) on conviction on indictment, imprisonment for a term not exceeding two years, or a fine, or both.”

Regulation 37

SCHEDULE 5 Consequential Amendments

PART 1 ENACTMENTS

Wildlife and Countryside Act 1981

1.  In section 15A of the Wildlife and Countryside Act 1981(3), in subsection (2), for paragraph (b) substitute—

“(b) Regulation (EU) No 528/2012 of the European Parliament and of the Council(4).”.

Natural Environment and Rural Communities Act 2006

2.  In section 43 of the Natural Environment and Rural Communities Act 2006(5), in subsection (3), for paragraph (c) substitute—

“(c) Regulation (EU) No 528/2012 of the European Parliament and of the Council;”.

PART 2 SUBORDINATE LEGISLATION

Control of Pesticides Regulations 1986

3.  In the Control of Pesticides Regulations 1986(6), omit Regulation 3(2)(j).

African Swine Fever (England) Order 2003

4.  In Article 12(2) of the African Swine Fever (England) Order 2003(7), for “the Biocidal Products Regulations 2001” substitute “Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products”.

African Swine Fever (Scotland) Order 2003

5.  In Article 12(2) of the African Swine Fever (Scotland) Order 2003(8), for “the Biocidal Products Regulations 2001” substitute “Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products”.

African Swine Fever (Wales) Order 2003

6.  In Article 12(2) of the African Swine Fever (Wales) Order 2003(9), for “the Biocidal Products Regulations 2001” substitute “Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products”.

Diseases of Animals (Approved Disinfectants) (England) Order 2007

7.—(1) The Diseases of Animals (Approved Disinfectants) (England) Order 2007(10) is amended as follows.

(2) In Article 3(2)(b), for “the Biocidal Products Regulations 2001” substitute “Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products”.

(3) In Article 6(1)(d), for “the Biocidal Products Regulations 2001” substitute “Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products”.

Diseases of Animals (Approved Disinfectants) (Wales) Order 2007

8.—(1) The Diseases of Animals (Approved Disinfectants) (Wales) Order 2007(11) is amended as follows.

(2) In Article 3(2)(b), for “the Biocidal Products Regulations 2001” substitute “Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products”.

(3) In Article 6(1)(c), for “the Biocidal Products Regulations 2001” substitute “Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products”.

Diseases of Animals (Approved Disinfectants) (Scotland) Order 2008

9.—(1) The Diseases of Animals (Approved Disinfectants) (Scotland) Order 2008(12) is amended as follows.

(2) In Article 3(2)(b), for “the Biocidal Products Regulations 2001” substitute “Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products”.

(3) In Article 6(1)(b)(iii), for “the Biocidal Products Regulations 2001” substitute “Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products”.

Health and Safety (Fees) Regulations 2012

10.  In the Health and Safety (Fees) Regulations 2012(13), for Regulation 24(16)(c) substitute—

“(c) the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013; and”.

(1)

S.I. 1986/1510, amended by S.I. 1997/188.

(2)

OJ No. L309, 24.11.2009, p.1.

(3)

1981 c. 69.

(4)

OJ No L167, 27.06.12, p.1.

(5)

2006 c. 16.

(6)

S.I. 1986/1510 as amended by S.I. 2001/880.

(7)

S.I. 2003/2913.

(8)

S.S.I. 2003/586.

(9)

S.I. 2003/3273.

(10)

S.I. 2007/448 as amended by S.I. 2011/1509.

(11)

S.I. 2007/2803.

(12)

S.S.I. 2008/219.

(13)

S.I. 2012/1652.