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The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019

Type Statutory-Instrument

Publication 2019-03-27

Last updated 2020-12-31

State In force

Department King's Printer of Acts of Parliament

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(7) In section 1.7.3 (marking of machinery) in both places in which it occurs for “CE” substitute “ UK ”.

(8) In section 1.7.4 (instructions)—

(a) in the first paragraph, for “the official Community language or languages of the EEA state in which it is placed on the market and/or put into service” substitute “ English ”;

(b) in the third paragraph omit “official Community”.

(9) In section 1.7.4.1 (general principles for the drafting of instructions)—

(a) at subsection (a) for “one or more official Community languages” substitute “ English ”;

(b) at subsection (b)—

(i) for “the official language(s) of the country where the machinery is to be used” substitute “ English ”;

(ii) omit “into that/those language(s)”;

(iii) for “language area in question” substitute “ United Kingdom ”.

(10) In section 1.7.4.2 (contents of the instructions)—

(a) in subsection (c) in both places in which it occurs omit “EC”;

(b) in subsection (u)—

(i) for “harmonised” substitute “ designated ”;

(ii) in both places in which it occurs for “EU directives” substitute “ enactments ”.

(11) In section 2.1.1 (general) in subsection (a) for “Directives” substitute “ enactments ”.

(12) In section 2.2.1.1 (instructions), in both places in which it occurs, for “harmonised” substitute “ designated ”.

(13) For section 2.4.10(i) substitute—

(i) an indication that the machinery may be subject to requirements for regular inspection by designated bodies, as provided for in the Plant Protection Products (Sustainable Use) Regulations 2012

(14) In section 3.6.3.1 (vibrations) for “harmonised” substitute “ designated ”.

Amendment to Schedule 2 Part 2 Annex II

24

(1) Schedule 2 Part 2 Annex II (Declarations) is amended as follows.

(2) In Section 1 Part A (EC Declaration of conformity of the machinery)—

(a) in the heading and in the third paragraph omit “EC”;

(b) in point 2 omit “, who must be established in an EEA state”;

(i) for “the Directive” substitute “ these Regulations ”;

(ii) for “Directives and/or” substitute “ enactments or ”;

(d) in point 5—

(i) for “notified” substitute “ approved ”;

(ii) for “EC type-” substitute “ Type- ” in both places in which it occurs;

(da) in point 6 for “notified” substitute “ approved ”;

(e) in point 7 for “published harmonised” substitute “ designated ”.

(3) in Section 1 Part B (declaration of incorporation of partly completely machinery)—

(a) in point 2 omit “, who must be established in an EEA state”;

(b) in point 4—

(i) for “Directives” substitute “ enactments ”;

(ii) omit “These references must be those of the texts published in the Official Journal of the European Union”;

(4) In Section 2 (Custody) omit “EC” from the first paragraph.

Amendment to Schedule 2 Part 3 Annex III

25

For Schedule 2 Part 3 Annex III (CE marking) substitute—

The UK marking must be affixed in the immediate vicinity of the name of the responsible person, using the same technique. Where the full quality assurance procedure prescribed in Annex X (Part 10 of this Schedule) has been applied, the UK marking must be followed by the identification number of the approved body.

Amendment to Schedule 2 Part 6 Annex VI

26

In Schedule 2 Part 6 Annex VI (assembly instructions for partly completed machinery) for “an official Community” substitute “ English or a ”.

Amendment to Schedule 2 Part 7 Annex VII

27

(1) Schedule 2 Part 7 Annex VII (technical files) is amended as follows.

(2) In Part A (technical file for machinery)—

(a) in the introductory paragraph—

(i) for “the Directive” substitute “ these Regulations ”;

(ii) for “one or more official Community languages” substitute “ English ”;

(b) in point 1(a)(ii) in both places in which it occurs omit “EC”;

(d) in point 2—

(i) in the first paragraph omit “and the competent authorities of any other EEA state”;

(ii) in the second paragraph—

(aa) for “territory of an EEA state” substitute “ United Kingdom ”;

(bb) omit “EC”;

(e) in point 3 for “competent national authorities” substitute “ enforcement authorities ”.

(3) In Part B (relevant technical documentation for partly completed machinery)—

(a) in the introductory paragraph—

(i) for “the Directive” substitute “ these Regulations ”;

(ii) for “one or more official Community languages” substitute “ English ”;

(b) in point (b)—

(i) in the second paragraph for “territory of an EEA state” substitute “ United Kingdom ”;

(ii) in both places in which it occurs in the second and third paragraphs, omit “or a competent authority of any other EEA state”.

Amendment to Schedule 2 Part 8 Annex VIII

28

In Schedule 2 Part 8 Annex VIII (assessment of conformity with internal checks on the manufacture of machinery) in points 1 and 3 for “the Directive” substitute “ these Regulations ”.

Amendment to Schedule 2 Part 9 Annex IX

29

(1) Schedule 2 Part 9 (EC type-examinations) is amended as follows.

(2) In the heading for “EC type-” substitute “ Type- ”.

(3) In the introductory paragraph—

(a) for “EC type-” substitute “ Type- ”;

(aa) for “a notified” substitute “ an approved ”;

(b) for “the Directive” substitute “ these Regulations ”.

(4) In point 2—

(a) for “an EC type-” substitute “ a Type- ”;

(b) for “a notified” substitute “ an approved ”;

(c) in each place in which it occurs (other than that referred to in sub-paragraph (b)) for “notified” substitute “ approved ”.

(5) In point 3 for “notified” substitute “ approved ”.

(6) In points 3.2 and 3.3 for “published harmonised” substitute “ designated ”.

(7) In point 4—

(a) for “the Directive” substitute “ these Regulations ”;

(b) in both places in which it occurs for “notified” substitute “ approved ”;

(8) For point 5 substitute—

(5) If the type does not satisfy the provisions of these Regulations, the approved body shall refuse to issue the applicant with a Type-examination certificate, giving detailed reasons for its refusal. It shall inform the applicant, the other approved bodies and the Secretary of State. An appeal procedure must be available.

(9) In point 6—

(a) in both places in which it occurs for “notified” substitute “ approved ”;

(b) in both places in which it occurs for “EC type-” substitute “ Type- ”.

(10) In point 7—

(a) for “Commission, the Member States” substitute “ Secretary of State ”;

(b) for “Commission and the Member States” substitute “ Secretary of State ”;

(d) for “EC type-” substitute “ Type- ”.

(11) For the text in point 8 substitute—

(8) Files and correspondence referring to the Type-examination procedures shall be written in English or any other language acceptable to the approved body.

(12) In point 9, 9.1, the first paragraph of 9.3 and 9.4 for “EC type-” substitute “ Type- ”.

(13) In ... each place in which it occurs in point points 9.1 and 9.3, for “notified” substitute “ approved ”.

Amendment to Schedule 2 Part 10 Annex X

30

In Schedule 2 Part 10 Annex X (full quality assurance)—

(a) in the introductory paragraph and in the first paragraph in point 2.1 for “a notified” substitute “ an approved ”;

(b) for “notified” substitute “ approved ” in—

(i) the fourth indent to point 2.1;

(ii) the first paragraph of point 2.3;

(iii) the second paragraph and the third paragraph of point 2.4;

(iv) point 3;

(v) the first paragraph of point 3.2;

(vi) point 3.3;

(vii) the first paragraph in both places in which it occurs and in the final paragraph of point 3.4;

(viii) the second indent to point 4;

(d) in the second indent to point 2.2 and in the second paragraph to point 2.3 for “harmonised” substitute “ designated ”.

Amendment to Schedule 2 Part 11 Annex XI

31

In Schedule 2 Part 11 Annex XI (minimum criteria to be taken into account by Member States for the notification of bodies)—

(a) in the heading for “Member States for the notification” substitute “ the Secretary of State for approval ”;

(aa) in point 3 for “notified” substitute “ approved ”;

(b) in point 8—

(i) for “notified” substitute “ approved ”;

(ii) omit “take part directly or be represented in European standardisation, or”.

Amendment to Schedule 3

32

In Schedule 3—

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

(b) in paragraph 1(k) for “Council Directive 2006/95/EC of 12 December 2006 on the harmonisation of the laws of Member States” substitute “ The Electrical Equipment (Safety) Regulations 2016 ”;

Amendment to Schedule 4

33

In Schedule 4 (appeals against notified body decisions)—

(a) in the heading for “notified” substitute “ approved ”;

(b) in paragraph 1—

(i) for “a UK notified” substitute “ an approved ”;

(ii) for “UK notified” substitute “ approved ”.

Amendment to Schedule 5

34

In Schedule 5 (enforcement)—

(a) in points (8)(f)(i), (10)(e)(i) and in paragraph 16 for “CE” substitute “ UK ”;

(b) in paragraph 16 omit “with a view to that information being passed by the Secretary of State to the Commission”.

SCHEDULE 13 — Amendment of the Aerosol Dispensers Regulations 2009

Introduction

1

The Aerosol Dispensers Regulations 2009 are amended in accordance with paragraphs 2 to 8.

Amendment to regulation 2

2

(1) Regulation 2 (interpretation) is amended as follows.

(2) In paragraph (1)—

(a) omit the definition of “compliance mark”;

(b) for the definition of “relevant aerosol dispenser” substitute—

“relevant aerosol dispenser” means an aerosol dispenser which does not have a maximum capacity of— (a) less than 50ml; or (b) greater than that specified— (i) in point 3.1 of Schedule 1A, in relation to metal aerosol dispensers (1000ml); (ii) in point 4.1.1 of Schedule 1A, in relation to aerosol dispensers with plastic coated or permanently protected glass containers or plastic aerosol dispensers which cannot splinter on bursting (220ml); or (iii) in point 4.2.1 of Schedule 1A, in relation to aerosol dispensers with unprotected glass containers or plastic aerosol dispensers which may splinter on bursting (150ml);

“UK marking” means the marking in the form set out in Annex 2 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.

(3) After paragraph (1) insert—

(1A) Schedule 1A reproduces the provisions of the Annex to the Directive with amendments to correct deficiencies in retained EU law. (1B) A reference to a provision of Schedule 1A is a reference to the equivalent provision of the Annex to the Directive as set out in that Schedule.

(4) In paragraph (2)—

(a) for “the Annex to the Directive” substitute “ Schedule 1A ”;

(b) after “is a reference to” insert “ a test method specified in point 6.1.4.1(b) or (c) which is ”;

(i) for “that Annex” substitute “ the Annex to the Directive ”;

(ii) after “point 6.1.4.3” insert “ of that Annex ”;

(d) in subparagraph (b) after “6.1.4.3” insert “ of Schedule 1A ”.

Amendment to regulation 3

3

In regulation 3 (requirements for the marking of aerosol dispensers)—

(a) in paragraph (1)—

(i) after “dispenser” insert “ or where paragraph (1A) applies, on a label affixed to, or a document accompanying, the aerosol dispenser ”;

(ii) for “a compliance mark” substitute “ the UK marking ”;

(aa) after paragraph (1) insert—

(1A) For a period of 24 months beginning with IP completion day, the UK marking may be affixed to— (a) a label affixed to the aerosol dispenser; or (b) a document accompanying the aerosol dispenser.

(b) in each place in which it occurs, for “the Annex to the Directive” substitute “ Schedule 1A ”;

(d) in paragraph (7)(c)—

(i) after “6.1.4.1(a)”, “6.1.4.1(b)” and “6.1.4.1(c)” (in paragraphs (i), (ii) and (iii) respectively), insert “ of Schedule 1A ”;

(ii) after “6.1.4.2” in both places in which it occurs insert “ of that Schedule ”;

(e) for paragraph (8)(a) substitute—

(a) the following information— (i) the name and address or trade mark of the person responsible for marketing the aerosol dispenser; (ii) code markings enabling the filling batch to be identified; (iii) the details referred to in point 2.2 of Schedule 1A; and (iv) where an aerosol dispenser— (aa) contains flammable components as defined in point 1.8 of Schedule 1A; and (bb) is not classified as extremely flammable or flammable in accordance with the classifications set out in point 1.9 of Schedule 1A; the quantity of flammable material contained in the aerosol dispenser must be clearly stated on the label in legible and indelible wording in the following form—“X % by mass of the contents are flammable”;

Insertion of regulation 3A

4

After regulation 3, insert—

(3A) (1) The Secretary of State may by regulations amend Schedule 1A where the Secretary of State considers it necessary to do so in order to take technical progress into account. (2) The power to make regulations made under paragraph (1) includes power— (a) to make different provisions for different cases; and (b) to make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate. (3) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

Amendment to regulation 4

5

For regulation 4 substitute—

(4) (1) Subject to paragraph (2), a person shall not supply or have in his possession for supply a relevant aerosol dispenser which is not marked with the UK marking or the symbol “3” (inverted epsilon). (2) Where regulation 3(1A) applies, paragraph (1) does not apply where the UK marking is affixed to— (a) a label affixed to the aerosol dispenser; or (b) a document accompanying the aerosol dispenser.

Amendment to regulation 5

6

In regulation 5 (prohibition of sale or supply of non-compliant marked aerosol dispensers)—

(a) for paragraph (a), substitute—

(a) an aerosol dispenser which— (i) is marked with the UK marking where all the requirements referred to in regulation 3 relating to that aerosol dispenser are not complied with; ... (ia) has a label affixed to it, or a document accompanying it, which is marked with the UK marking, where— (aa) the requirements of regulation 3 are not complied with; or (bb) the requirements of regulation 3 are complied with but the period referred to in regulation 3(1A) has elapsed; or (ii) is marked with the symbol “3” (inverted epsilon) where either— (aa) all the requirements of regulation 5A(3) are not complied with; or (bb) all the requirements of regulation 5B are not complied with; or

(b) for paragraph (b) substitute—

(b) an aerosol dispenser which— (i) is marked with a mark so closely resembling the UK marking or the symbol “3” (inverted epsilon) as to be likely to deceive; or (ii) has a label affixed to it or a document accompanying it which is marked with a mark so closely resembling the UK marking as to be likely to deceive.

Insertion of regulation 5A

7

After regulation 5 insert—

(5A) (1) In this regulation any reference to an Article or an Annex is a reference to an Article of or the Annex to the Directive. (2) Paragraph (3) sets out the requirements which must be complied with under regulation 5(a)(ii)(aa) in order to mark an aerosol dispenser with the symbol “3” (inverted epsilon). (3) The requirements referred to in paragraph (2) are that— (a) the aerosol dispenser is a relevant aerosol dispenser; ... (aa) the aerosol dispenser is supplied within a period of 12 months beginning with IP completion day; and (b) the relevant aerosol dispenser— (i) complies with the obligations of Article 8(1) (or where permitted by that Article, where its label complies with those requirements); (ii) complies with the requirements of Article 8(1a); (iii) bears or, where permitted by Article 8(1), has on its label the information required by Article 8(1)(d) and 8(1a) prepared in or translated into English (unless it is unlikely that the aerosol dispenser will be used in the United Kingdom); (iv) complies with the general provisions relating to construction set out in point 2.1 of the Annex; (v) complies with the provisions relating to the volume of the liquid phase set out in point 2.3 of the Annex; (vi) complies with the special provision set out in points 3, 4 and 5 of the Annex in the case of metal, glass and plastic dispensers respectively; (vii) meets the tests specified in point 6.1.1 of the Annex in the case of empty containers; (viii) meets the test specified in point 6.1.2 and 6.1.3 of the Annex in the case of empty metal and protected glass dispensers respectively; and (ix) satisfies one of the following paragraphs— (aa) it meets the test methods specified in point 6.1.4.1(a) of the Annex and the dispenser is not of a type referred to in point 6.1.4.2 of the Annex; (bb) it meets the test method specified in point 6.1.4.1(b) of the Annex and the dispenser is not of a type referred to in point 6.1.4.2 of the Annex; (cc) it meets the test method specified in point 6.1.4.1(c) of the Annex; and (c) the person responsible for the marketing of the relevant aerosol dispenser— (i) has affixed the symbol “3” (inverted epsilon) in accordance with Article 3; and (ii) has complied with the obligations set out after the heading to point 2 (general provisions) and immediately before point 2.1 of the Annex. (5B) (1) Paragraph (2) sets out the requirements that must be complied with under regulation 5(a)(ii)(bb) to mark an aerosol dispenser with the symbol “3” (inverted epsilon); (2) The requirements referred to in paragraph (1) are that— (a) the requirements of regulation 3 as it applies in Northern Ireland have been complied with in relation to the aerosol dispenser; and (b) the aerosol dispenser is qualifying Northern Ireland goods. (3) In this regulation “qualifying Northern Ireland goods” has the meaning given to it in in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.

Insertion of Schedule 1A

8

After the Schedule, insert—

SCHEDULE 1A (1) DEFINITIONS (1) Regulation (EC) No 1272/2008 “Regulation (EC) No 1272/2008” means Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006. (1) - “Pressures” means the internal pressures expressed in bars (relative pressures). (1) - “Test pressure” means the pressure to which an unfilled aerosol dispenser container may be subjected for 25 seconds without any leakage being caused or, in the case of metal or plastic containers, any visible or permanent distortion except as allowed under 6.1.1.2. (1) - “Bursting pressure” means the minimum pressure which causes the aerosol dispenser container to burst or rupture. (1) - “Total capacity of the container” means the volume in millilitres of an open container up to the rim of the opening. (1) - “Net capacity” means the volume in millilitres of a filled and closed aerosol dispenser. (1) - “Volume of liquid phase” means the volume of the non-gaseous phases in the filled and closed aerosol dispenser. (1) - “Test conditions” means the values of test and bursting pressures exerted hydraulically at 20° C (± 5°C). (1) - “Substance” means substance as defined in Article 2(7) of Regulation (EC) No 1272/2008. (1) - “Mixture” means mixture as defined in Article 2(8) of Regulation (EC) No 1272/2008. (1) Contents of aerosols shall be considered as flammable if they contain any component which is classified as flammable: (a) flammable liquid means a liquid having a flashpoint of not more than 93°C. (b) flammable solid means a solid substance or mixture which is readily combustible or may cause or contribute to fire as a result of friction; readily combustible solids are powdered, granular, or pasty substances or mixtures which are dangerous if they can be easily ignited by brief contact with an ignition source, such as a burning match, and if the flame spreads rapidly. (c) flammable gas means a gas or gas mixture having a flammable range with air at 20°C and a standard pressure of 1.013 bar. This definition does not cover pyrophoric, self—heating or water—reactive substances and mixtures, which shall never be components of aerosol contents. (1) For the purpose of these Regulations, an aerosol is considered as “non-flammable”, “flammable” or “extremely flammable” according to its chemical heat of combustion and mass content of flammable components, as follows: (a) the aerosol is classified as “extremely flammable” if it contains 85% or more flammable components and the chemical heat of combustion exceeds or is equal to 30 kJ/g; (b) the aerosol is classified as “non-flammable” if it contains 1% or less flammable components and the chemical heat of combustion is less than 20 kJ/g; (c) all other aerosols will be submitted to the flammability classification procedures set out in 1.9.1. to 1.10. or shall be classified as “extremely flammable”. The ignition distance test, the enclosed space test and the foam flammability test shall comply with point 6.3. (1) In the case of spray aerosols, the classification shall be made taking into account the chemical heat of combustion and on the basis of the results of the ignition distance test, as follows: (a) if the chemical heat of combustion is less than 20kJ/g: (i) the aerosol is classified as “flammable” if ignition occurs at a distance equal or greater than 15 cm but less than 75 cm; (ii) the aerosol is classified as “extremely flammable” if ignition occurs at a distance of 75 cm or more; (iii) if no ignition occurs in the ignition distance test, the enclosed space test shall be performed and in this case, the aerosol is classified as “flammable” if the time equivalent is less than or equal to 300 s/m³ or the deflagration density is less than or equal to 300 g/m³; otherwise the aerosol is classified as “non-flammable”; (b) if the chemical heat of combustion is equal to or more than 20 kJ/g, the aerosol is classified as “extremely flammable” if ignition occurs at a distance of 75 cm or more; otherwise the aerosol is classified as “flammable”. (1) In the case of foam aerosols, the classification shall be made on the basis of the results of the foam flammability test. (a) The aerosol product shall be classified as “extremely flammable” if: (i) the flame height is 20 cm or more and the flame duration is two seconds or more; or (ii) the flame height is 4 cm or more and the flame duration is seven seconds or more. (b) The aerosol product which does not meet the criteria in (a) is classified as “flammable” if the flame height is 4 cm or more and the flame duration is two seconds or more. (1) The chemical heat of combustion ΔHc shall be either determined by: (a) acknowledged rules of technology, described e.g. in standards such as ASTM D 240, ISO 13943 86.1 to 86.3 and NFPA 30B, or found in the scientifically established literature; or (b) applying the following calculation method: The chemical heat of combustion (ΔHc), in kilojoules per gram (kJ/g), can be calculated as the product of the theoretical heat of combustion (ΔHcomb), and a combustion efficiency, usually less than 1,0 (a typical combustion efficiency is 0,95 or 95%). For a composite aerosol formulation, the chemical heat of combustion is the summation of the weighted heats of combustion for the individual components, as follows: where: - ΔHc = chemical heat of combustion (kJ/g) of the product; - wi% = mass fraction of component i in the product; - ΔHc(i) = specific heat of combustion (kJ/g) of component i in the product. The person responsible for the marketing of the aerosol dispenser has to describe the method used for determining the chemical heat of combustion in a document to be made readily available in English at the address specified on the label in accordance with regulation 3(8)(a)(i), if the chemical heat of combustion is used as a parameter for assessing the flammability of aerosols, according to the provisions of these Regulations. (2) Without prejudice to specific provisions of this Schedule on requirements related to the flammability and pressure hazard, the person responsible for the marketing of aerosol dispensers is under an obligation to analyse the hazards in order to identify those which apply to their aerosol dispensers. Where appropriate, this analysis shall include a consideration of the risks resulting from the inhalation of the spray ejected by the aerosol dispenser under normal and reasonably foreseeable conditions of use, taking into account droplet size distribution in conjunction with physical and chemical properties of the contents. The person responsible for the marketing of the aerosol dispenser must then design, construct and test it and, if applicable, draft special statements concerning its use, taking account of this analysis. (2) (2) The filled aerosol dispenser must be such that, under normal conditions of use and storage, it complies with the provisions of this Schedule. (2) The valve must enable the aerosol dispenser to be virtually hermetically sealed under normal conditions of storage or transport and must be protected, for example by means of a protective cap, against any unintentional opening and any deterioration. (2) There must be no possibility that the mechanical resistance of the aerosol dispenser can be impaired by the action of the substances contained in it, even during prolonged storage. (2) Without prejudice to Regulation (EC) No 1272/2008, each aerosol dispenser must visibly bear the following and indelible marking: (a) where the aerosol is classified as “non-flammable” according to the criteria of point 1.9, the signal word “Warning” and the other label elements for Aerosols Category 3 provided for in Table 2.3.1 of Annex I to Regulation (EC) No 1272/2008; (b) where the aerosol is classified as “flammable” according to the criteria of point 1.9, the signal word “Warning” and the other label elements for Aerosols Category 2 provided for in Table 2.3.1 of Annex I to Regulation (EC) No 1272/2008; (c) where the aerosol is classified as “extremely flammable” according to the criteria of point 1.9, the signal word “Danger” and other label elements for Aerosols Category 1 provided for in Table 2.3.1 of Annex I to Regulation (EC) No 1272/2008; (d) where the aerosol dispenser is a consumer product, the precautionary statement P102 provided for in Part 1, Table 6.1 of Annex IV to Regulation (EC) No 1272/2008; (e) any additional operating precautions which alert consumers to the specific dangers of the product; if the aerosol dispenser is accompanied by separate instructions for use, the latter must also reflect such operating precautions. (2) The volume of the liquid phase at 50°C must not exceed 90% of the net capacity. (3) (3) The total capacity of these containers may not exceed 1000 ml. (3) (a) For containers filled at a pressure of less than 6.7 bars at 50°C, the test pressure must be equal to at least 10 bars. (b) For containers filled at a pressure equal to or greater than 6.7 bars at 50°C, the test pressure must be 50% higher than the internal pressure at 50° C. (3) The pressure at 50°C in the aerosol dispenser must not exceed the values provided for in the following table, depending upon the content of gases in the aerosol dispenser:

*Content of gases*	*Pressure at 50°C*
Liquified gas or mixture of gases having a flammable range with air at 20°C and a standard pressure of 1,013 bar	12 bar
Liquified gas or mixture of gases not having a flammable range with air at 20°C and a standard pressure of 1,013 bar	13.2 bar
Compressed gases or gases dissolved under pressure not having a flammable range with air at 20°C and a standard pressure of 1.013 bar	15 bar

(4) (4) Containers of this type may be used for filling with compressed, liquefied or dissolved gas. (4) The total capacity of these containers may not exceed 220 ml. (4) The coating must be a protective envelope of plastic or other suitable material, intended to prevent the risk of flying particles of glass if the container is accidently broken, and must be so designed that there are no flying particles of glass if the filled aerosol dispenser, brought to a temperature of 20° C, is dropped from a height of 1.8 m onto a concrete floor. (4) (a) Containers used for filling with compressed or dissolved gas must resist a test pressure equal to at least 12 bars. (b) Containers used for filling with liquefied gas must resist a test pressure equal to at least 10 bars. (4) This table shows the pressure limits permitted at 20°C in relation to the percentage of gas. (a) Aerosol dispensers filled with compressed gas shall not be required to withstand a pressure of more than 9 bars at 50°C. (b) Aerosol dispensers filled with dissolved gas shall not be required to withstand a pressure of more than 8 bars at 50°C. (c) Aerosol dispensers containing liquefied gas or mixtures of liquefied gas shall not be required to withstand, at 20°C, pressures higher than those shown in the following table:

Total capacity	Percentage by weight of liquefied gas in the total mixture	Percentage by weight of liquefied gas in the total mixture	Percentage by weight of liquefied gas in the total mixture
Total capacity	20 %	50 %	80 %
50 to 80 ml	3.5 bars	2.8 bars	2.5 bars
< 80 to 160 ml	3.2 bars	2.5 bars	2.2 bars
< 160 to 220 ml	2.8 bars	2.1 bars	1.8 bars

Pressure limits for percentages of gas not shown in the table shall be extrapolated from it.
(4) Aerosol dispensers using unprotected glass containers shall be filled exclusively with liquefied or dissolved gases. (4) The total capacity of these containers may not exceed 150ml. (4) The test pressure of the container must be equal to at least 12 bars. (4) This table shows the pressure limits permitted at 20°C in relation to the percentage of liquefied gas. (a) Aerosol dispensers filled with dissolved gas shall not be required to withstand a pressure of more than 8 bars at 50°C. (b) Aerosol dispensers containing liquefied gas shall not be required to withstand, at 20° C, pressures in excess of those shown in the following table:

Total capacity	Percentage by weight of liquefied gas in the total mixture	Percentage by weight of liquefied gas in the total mixture	Percentage by weight of liquefied gas in the total mixture
Total capacity	20 %	50%	80%
50 to 70 ml	1.5 bar	1.5 bar	1.25 bar
< 70 to 150 ml	1.5 bar	1.5 bar	1 bar

Pressure limits for percentages of gas not shown in the table shall be extrapolated from it.
(5) (5) Plastic aerosol dispensers which may splinter on bursting shall be treated in the same way as unprotected glass aerosol dispensers. (5) Plastic aerosol dispensers which cannot splinter on bursting shall be treated in the same way as glass aerosol dispensers with a protective coating. (6) (6) (6) (6) Metal, glass or plastic aerosol dispensers must be able to withstand a hydraulic pressure test as laid down in 3.1.1, 4.1.3 and 4.2.2. (6) Metal containers showing assymetrical or major distortions or other similar faults shall be rejected. A slight symmetrical distortion of the base or one affecting the profile of the upper casing shall be allowed provided that the container passes the bursting test. (6) The person responsible for marketing the aerosol dispenser must ensure that the bursting pressure of containers is at least 20% higher than the test pressure laid down. (6) The manufacturer must ensure that the containers satisfy the test requirements laid down in 4.1.2. (6) (6) Aerosol dispensers shall be subject to one of the following final test methods. (a) Hot water bath test Each filled aerosol dispenser shall be immersed in a hot water bath. (i) The temperature of the water bath and the duration of the test shall be such that the internal pressure reaches that which would be exerted by its contents at a uniform temperature of 50°C. (ii) Any aerosol dispenser showing visible permanent distortion or a leak must be rejected. (b) Hot final test methods Other methods for heating the contents of aerosol dispensers may be used if they guarantee that the pressure and temperature in each filled aerosol dispenser reach the values required for the hot water bath test and distortions and leaks are detected with same precision as in the case of the hot water bath test. (c) Cold final test methods An alternative cold final test method may be used if it is in accordance with the provisions of an alternative method to the hot water bath test for aerosol dispensers in paragraph 6.2.6.3.2 of Chapter 6.2 of Part 6 of Annex A to the European Agreement on the international carriage of dangerous goods by road . (6) For aerosol dispensers the contents of which undergo a physical or chemical transformation changing their pressure characteristics after filling and before first use, cold final test methods according to point 6.1.4.1(c) should be applied. (6) In case of test methods according to points 6.1.4.1(b) and 6.1.4.1(c): (a) the test method must be approved by the Secretary of State; (b) the person responsible for the marketing of aerosol dispensers must submit an application for approval to the Secretary of State. The application must be accompanied by the technical file describing the method; (c) the person responsible for the marketing of aerosol dispensers must, for surveillance purposes, keep the approval of the Secretary of State, the technical file describing the method and, if applicable, control reports readily available at the address specified on the label in accordance with regulation 3(8)(a)(i); and (d) the technical file must be in English. (6) (6) The test pressure shall be applied for 25 seconds on five containers selected at random from a homogeneous batch of 2500 unfilled containers, that is, manufactured from the same materials by the same continuous batch manufacturing process, or from a batch constituting one hour's production. If any one of these containers does not pass the test, ten additional containers shall be drawn at random from the same batch and put through the same test. If any one of these aerosol containers does not pass the test, the whole batch shall be unsuitable for use. (6) Air and water-tightness inspection tests shall be carried out by immersing a representative number of filled aerosol dispensers in a bath of water. The temperature of the bath and the period of immersion must be such as to enable the contents of the aerosol dispenser to attain a uniform temperature of 50°C during the time required to ensure that there is no bursting or rupture. Any batch of aerosol dispensers which does not pass these tests must be considered unsuitable for use. (6) (6) (6) (6) This test standard describes the method to determine the ignition distance of an aerosol spray in order to assess the associated flame risk. The aerosol is sprayed in the direction of an ignition source at intervals of 15cm to observe if ignition and sustained combustion of the spray takes place. Ignition and sustained combustion is defined as when a stable flame is maintained for at least five seconds. The ignition source is defined as a gas burner with a blue, non-luminous flame 4-5cm in height. (6) This test is applicable to aerosol products with a spray distance of 15 cm or more. Aerosol products with a spray distance of less than 15 cm such as dispensing foams, mousses, gels and pastes or fitted with a metering valve, are excluded from this test. Aerosol products that dispense foams, mousses, gels or pastes are subject to testing under the aerosol foam flammability test. (6) (6) The following apparatus is required:

Water bath maintained at 20°C	accurate to ± 1°C
Calibrated laboratory scales (balance)	accurate to ± 0.1 g
Chronometer (stopwatch)	accurate to ± 0.2 s
Graduated scale, support and clamp	graduations in cm
Gas burner with support and clamp
Thermometer	accurate to ± 1°C
Hygrometer	accurate to ± 5%
Pressure gauge	accurate to ± 0.1 bar

(6) (6) (6) Before testing, each aerosol dispenser shall be conditioned and then primed by discharging for approximately one second. The purpose of this action is to remove non-homogeneous material from the diptube. (6) The instructions of use shall be strictly followed, including whether the dispenser is intended to be used in the upright or inverted position. When shaking is required, shake immediately before testing. (6) The test shall be carried out in a draught-free environment capable of ventilation, with the temperature controlled at 20°C ± 5°C and relative humidity in the range 30-80%. (6) Each aerosol dispenser is to be tested: (a) when full according to the complete procedure, with the gas burner in the range of 15-90cm distance from the actuator of the aerosol can; (b) when 10-12% full nominal (% by mass) only one test, either at 15cm distance from the actuator when the spray from a full can did not ignite at all, or at the flame ignition distance of the spray of a full can plus 15cm. (6) During the test, the can shall be positioned as indicated by label instructions. The ignition source shall be positioned accordingly. (6) The following procedure requires testing the spray at intervals of 15cm between the burner flame and the aerosol actuator, in the range of 15-90cm. It is efficient to start at 60cm distance between burner flame and aerosol actuator. The distance between burner flame and aerosol actuator shall be increased by 15cm in the case of an ignition of the spray at 60cm distance. The distance shall be decreased by 15cm in the case of no ignition at 60cm distance between burner flame and aerosol actuator. The aim of the procedure is to determine the maximum distance between aerosol actuator and burner flame that leads to sustained combustion of the spray or to determine that ignition could not be obtained at 15cm distance between the burner flame and the aerosol's actuator. (6) (a) a minimum of 3 full aerosol dispensers per product shall be conditioned to 20°C ± 1 °C with at least 95 % of the dispenser immersed in the water for at least 30 minutes before each test (if the aerosol is fully immersed, 30 minutes conditioning is sufficient); (b) comply with general requirements; record the temperature and relative humidity of the environment; (c) weigh an aerosol dispenser and note its mass; (d) determine the internal pressure and initial discharge rate at 20°C ± 1°C (to eliminate faulty or partly filled aerosol dispensers); (e) support the gas burner on a flat horizontal surface or fix the burner to a support by means of a clamp; (f) ignite the gas burner; the flame shall be non-luminous and approximately 4-5cm high; (g) place the actuator's exit orifice at the required distance from the flame; the aerosol shall be tested in the position it is designed to be used, e.g. upright or inverted; (h) level the actuator's orifice and burner flame, ensuring that the orifice is properly directed towards and aligned with the flame (see Figure below); the spray shall be expelled through the top half of the flame; (i) comply with the general requirements regarding shaking of the dispenser; (j) actuate the valve of the aerosol dispenser, to discharge its contents for five seconds, unless ignition occurs; if ignition occurs, continue discharging and time the duration of the flame for five seconds, from the start of ignition; (k) note the ignition results for the distance between the gas burner and the aerosol dispenser in the table provided; (l) if no ignition occurs during step (j), the aerosol shall be tested in alternative orientations, e.g. inverted for upright use products, to check if ignition is obtained; (m) repeat steps (g) to (l) twice more (a total of 3) for the same can at the same distance between the gas burner and the aerosol actuator; (n) repeat the test procedure for another two aerosol cans of the same product at the same distance between gas burner and aerosol actuator; (o) repeat steps (g) to (n) of the test procedure at a distance between 15 and 90 cm between the actuator of the aerosol can and the burner flame depending on the outcome of each test (see also 6.3.1.3.1.4 and 6.3.1.3.1.5); (p) if no ignition occurs at 15cm, the procedure is finished for initially full cans; the procedure is also finished when ignition and sustained combustion is obtained at a distance of 90cm; if ignition could not be obtained at 15cm distance, record that ignition did not occur; the maximum distance between burner flame and the aerosol's actuator for which an ignition and sustained combustion was observed is noted as the “ignition distance”, in all other circumstances; (q) one test shall also be conducted on three cans of 10-12% nominal fill level; these cans shall be tested at a distance between the aerosol's actuator and the burner flame of the “flame ignition distance of full cans + 15cm”; (r) discharge an aerosol can to a 10-12% nominal fill level (by mass) in bursts of 30 seconds maximum; observe a 300 seconds minimum time period between bursts; during this interim period dispensers shall be placed in the water bath for conditioning; (s) repeat steps (g) to (n) for 10-12% nominal fill aerosol cans, omitting steps (l) and (m); this test shall only be performed with the aerosol in one position, e.g. upright or inverted, corresponding with that which produced the ignition (if any) for filled cans; (t) record all results in the Table 6.3.1.1 as shown below. (6) All experiments shall be performed in a fume hood in a room that may be well ventilated. Ventilation of the fume hood and room can be applied for at least three minutes after each test. Take all necessary safety precautions to prevent the inhalation of combustion products. (6) The cans with a 10-12 % nominal fill level shall be tested only once. The result tables need only one result per can indicated. (6) When the test in the position in which the dispenser is designed to be used gives a negative result, the test shall be repeated in the position of the dispenser most likely to result in a positive result. (6) (6) All the results shall be recorded. Table 6.3.1.1 below shows the model of “result table” to be used.

Date	Date	Temperature … °C Relative humidity … %	Temperature … °C Relative humidity … %	Temperature … °C Relative humidity … %	Temperature … °C Relative humidity … %	Temperature … °C Relative humidity … %	Temperature … °C Relative humidity … %	Temperature … °C Relative humidity … %	Temperature … °C Relative humidity … %	Temperature … °C Relative humidity … %
Name of product	Name of product
Net volume		Can 1	Can 1	Can 1	Can 2	Can 2	Can 2	Can 3	Can 3	Can 3
Initial level of filling		%	%	%	%	%	%	%	%	%
Dispenser distance	Test	1	2	3	1	2	3	1	2	3
15 cm	Ignition?
	Y or N
30 cm	Ignition?
	Y or N
45 cm	Ignition?
	Y or N
60 cm	Ignition?
	Y or N
75 cm	Ignition?
	Y or N
90 cm	Ignition?
	Y or N
Observations — including can position

(6) (6) This test standard describes the method to assess the flammability of products emerging from aerosol dispensers due to their propensity to ignite in an enclosed or confined space. The contents of an aerosol dispenser are sprayed into a cylindrical test vessel containing a burning candle. If an observable ignition occurs, the elapsed time and amount discharged is noted. (6) (6) The following apparatus is required:

Chronometer (stopwatch)	accurate to ± 0,2 s
Water bath maintained at 20 °C	accurate to ± 1 °C
Calibrated laboratory scales (balance)	accurate to ± 0,1 g
Thermometer	accurate to ± 1 °C
Hygrometer	accurate to ± 5 %
Pressure gauge	accurate to ± 0.1 bar
Cylindrical test vessel	as detailed below

(6) (6) A cylindrical vessel approximately 200 dm³ volume, approximately 600mm in diameter and approximately 720mm long and open at one end shall be modified as follows: (a) a closure system consisting of a hinged cover shall be matched to the open end of the receptacle; or (b) a plastic film 0.01 to 0.02 mm thick may be used as a closure system; if the test is carried out with a plastic film this must be used as described below: stretch the film over the open end of the drum and hold it in place with an elastic band; the strength of the band shall be such that when placed around the drum resting on its side, it stretches by only 25mm when a mass of 0.45 kg is attached to its lowest point; cut a 25 mm slit in the film, starting 50 mm from the edge of the drum. Ensure that the film is taut; (c) at the other end of the drum drill a 50mm diameter hole 100mm from the edge in such a way that the orifice is uppermost when the receptacle is laid down and ready for the test (Figure below); (d) on a 200 × 200 mm metal support place a paraffin wax candle 20 to 40 mm in diameter and 100 mm high; the candle shall be replaced when having a height of less than 80 mm; the candle's flame is protected from the action of the spray by a 150 mm wide, 200 mm high deflector; this includes the plane inclined at 45° produced 150 mm from the base of the deflector (see Figure below); (e) the candle placed on the metal support shall be positioned midway between the two ends of the drum (see Figure below); (f) the drum is laid on the ground or on a support at a spot where the temperature is between 15 °C and 25 °C; the product to be tested will be sprayed within the drum of roughly 200 dm³ in which there will be a source of ignition. (6) Usually, the product leaves the aerosol can at an angle of 90° relevant to the vertical axis of the can. The layout and procedure described refers to this kind of aerosol product. In the case of unusually operating aerosols (e.g. vertical-spray aerosol dispensers) it will be necessary to record changes to equipment and procedures in accordance with good laboratory practice, such as International Standard ISO/IEC 17025:2007 General requirements for the competence of testing and calibration laboratories. (6) (6) (6) Before testing, each aerosol dispenser shall be conditioned and then primed by discharging for approximately 1 second. The purpose of this action is to remove non-homogeneous material from the diptube. (6) The instructions of use shall be strictly followed, including whether the dispenser is intended to be used in the upright or inverted position. When shaking is required, shake immediately before testing. (6) The tests shall be carried out in a draught-free environment capable of ventilation, with the temperature controlled at 20°C ± 5°C and relative humidity in the range 30-80%. (6) (a) a minimum of 3 full aerosol dispensers per product shall be conditioned to 20 °C ± 1 °C in a water bath with at least 95 % of the dispenser immersed in the water for at least 30 min (if the aerosol is fully immersed, 30 min conditioning is sufficient); (b) measure or calculate the actual volume of the drum in dm³; (c) comply with general requirements; record the temperature and relative humidity of the environment; (d) determine the internal pressure and initial discharge rate at 20 °C ± 1 °C (to eliminate faulty or partly filled aerosol dispensers); (e) weigh one of the aerosol dispensers and note its mass; (f) light the candle and apply the closure system (cover or plastic film); (g) place the aerosol dispenser actuator orifice 35 mm or closer for a wide spray product, from the centre of the entrance hole in the drum; start the chronometer (stopwatch) and following the instructions for use of the product; direct the spray towards the centre of the opposite extremity (cover or plastic film); the aerosol shall be tested in the position it is designed to be used, e.g. upright or inverted; (h) spray until ignition occurs; stop the chronometer and note the time elapsed; re-weigh the aerosol dispenser and note its mass; (i) ventilate and clean the drum removing any residue likely to affect subsequent tests; allow the drum to cool if necessary; (j) repeat the test procedure steps (d) to (i) for another two aerosol dispensers of the same product (three in total, note: each dispenser is only tested once). (6) (6) A test report containing the following information shall be drawn up: (a) the product tested and its references; (b) the internal pressure and discharge rate of the aerosol dispenser; (c) the temperature and relative air humidity of the room; (d) for each test, the discharge time (s) needed to achieve ignition (if the product does not ignite, state this); (e) the mass of the product sprayed during each test (in g); (f) the actual volume of the drum (in dm³). (6) The time equivalent (teq) needed to achieve ignition in one cubic metre can be calculated as follows: (6) The deflagration density (Ddef) needed to achieve ignition during the test may also be calculated as follows: (6) (6) (6) This test standard describes the method to determine the flammability of an aerosol spray emitted in the form of a foam, mousse, gel or paste. An aerosol, which emits a foam, mousse, gel or paste is sprayed (approximately 5 g) on a watchglass and an ignition source (candle, wax taper, match or lighter) is placed at the base of the watchglass to observe if ignition and sustained combustion of the foam, mousse, gel or paste occurs. Ignition is defined as a stable flame maintained for at least two seconds and a minimum 4 cm in height. (6) (6) The following apparatus is required:

Graduated scale, support and clamp	gradations in cm
Fire-resistant watchglass roughly 150 mm in diameter
Chronometer (stopwatch)	accurate to ± 0,2 s
Candle, wax taper, match or lighter
Calibrated laboratory scales (balance)	accurate to ± 0,1 g
Water bath maintained at 20°C	accurate to ± 1 °C
Thermometer	accurate to ± 1 °C
Hygrometer	accurate to ± 5 %
Pressure gauge	accurate to ± 0.1 bar

(6) The watch-glass is placed on a fire-resistant surface within a draught-free area that may be ventilated after each test. The graduated scale is positioned exactly behind the watch-glass and held vertically by means of a support and clamp. (6) The scale is positioned in such a way that its origin is on a level with the watch-glass base in a horizontal plane. (6) (6) (6) Before testing, each aerosol dispenser shall be conditioned and then primed by discharging for approximately 1 second. The purpose of this action is to remove non-homogeneous material from the diptube. (6) The instructions of use shall be strictly followed, including whether the dispenser is intended to be used in the upright or inverted position. When shaking is required, shake immediately before testing. (6) The tests shall be carried out in a draught-free environment capable of ventilation, with the temperature controlled at 20°C ± 5°C and relative humidity in the range of 30-80%. (6) (a) a minimum of four full aerosol dispensers per product shall be conditioned to 20 °C ± 1°C with at least 95% of the dispenser immersed in the water for at least 30 min before each test (if the aerosol is fully immersed, 30 minutes conditioning is sufficient); (b) comply with general requirements. Record the temperature and relative humidity of the environment; (c) determine the internal pressure at 20°C ± 1 °C (to eliminate faulty or partly filled aerosol dispensers); (d) measure the discharge or flow rate of the aerosol product to be examined, so that the amount of test product dispensed can be more accurately gauged; (e) weigh one of the aerosol dispensers and note its mass; (f) on the basis of the measured discharge or flow rate and following the manufacturer's instructions, release approximately 5 g of the product onto the centre of the clean watch glass with the aim of producing a mound no higher than 25 mm; (g) within five seconds of completion of discharge, apply the source of ignition to the edge of the sample at its base and at the same time start the chronometer (stopwatch); if necessary, the ignition source shall be removed from the edge of the sample after approximately two seconds, in order to clearly observe if ignition has occurred; if no ignition of the sample is apparent, the ignition source shall be reapplied to the edge of the sample; (h) if ignition occurs note the following points: (i) the maximum height of the flame in cm above the base of the watch-glass; (ii) the flame duration in s; (iii) dry and re-weigh the aerosol dispenser and calculate the mass of the released product; (i) ventilate the test area immediately after each test; (j) if ignition is not obtained and the released product remains in the form of a foam or paste throughout its period of use, steps (e) to (i) shall be repeated; allow the product to stand for 30 seconds, 1 minute, 2 minutes or 4 minutes before applying the ignition source; (k) repeat the test procedure steps (e) to (j) twice more (a total of 3) for the same can; (l) repeat the test procedure steps (e) to (k) for another two aerosol cans (3 cans in total) of the same product. (6) (6) A test report containing the following information shall be drawn up: (a) whether the product ignites; (b) the maximum flame height in cm; (c) the duration of flame in seconds; (d) the mass of the product tested.

SCHEDULE 14 — Amendment of the Accreditation Regulations 2009

General

1

The Accreditation Regulations 2009 are amended in accordance with paragraphs 2 to 4.

2

In regulation 2—

(a) in paragraph (1)—

(i) for the definition of “the EC Regulation” substitute—

“RAMS” means Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9th July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;

(b) in paragraph (2) for “the EC Regulation” in both places in which it occurs substitute “ RAMS ”.

3

In regulation 3—

(a) for “the EC Regulation” substitute “ RAMS ”;

(b) for “national accreditation body” substitute “ UK national accreditation body ”.

4

In regulations 4(1), 5 and 6 and paragraph (1) of the Schedule for “the EC Regulation” substitute “ RAMS ”.

SCHEDULE 15 — Amendment of the Toys (Safety) Regulations 2011

Interpretation

1

The Toys (Safety) Regulations 2011are amended in accordance with paragraphs 2 to 43.

Amendment to regulation 2

2

(1) In regulation 2(2) (revocation, saving and amendment)—

(a) before “as if” insert “subject to the modifications in paragraph (2A);

(b) after paragraph (2) insert—

(2A) The modifications referred to in paragraph (2) are— (a) that references to “the Community” are to be read as including the United Kingdom; and (b) paragraph (5) of regulation 9 is to be read as if “, the Commission of the Communities, the other member States and other approved bodies” were omitted.

Insertion of regulation 2A

3

After regulation 2 insert—

(2A) (1) In this regulation— - “pre-exit period” means the period beginning with 19th August 2011 and ending immediately before IP completion day; - “product” means a toy to which these Regulations apply. (2) Subject to paragraphs (3) and (4), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 15 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 , any obligation or prohibition to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that product. (3) Paragraph (2) does not apply to— (a) any obligation of any enforcement authority to inform the European Commission or the member States of any matter; or (b) any obligation to take action outside of the United Kingdom in respect of that product. (4) Where an EC-type examination was issued in relation to a product to which paragraph (2) applies references to “Type examination” in regulations 22 and 45 are to be read as referring to an EC-type examination referred to in regulation 44 as it had effect immediately before IP completion day. (5) Where during the pre-exit period— (a) a product has not been placed on the market; and (b) a manufacturer has taken any action under regulations 11 to 13 as they had effect immediately before IP completion day in relation to that product, that action has effect as if it had been done under regulations 11 to 13 as they have effect on and after IP completion day.

Amendment to regulation 3

4

In regulation 3 (interpretation)—

(a) in the definition of “the Directive” at the end insert “ (as it has effect immediately before IP completion day) ”;

(b) after the definition of “the GPSR” insert—

“approved body requirements” has the meaning given to it in regulation 40A;

(d) omit the definition of “CE marking”;

(e) before the definition of “distributor” insert—

“designated standard” has the meaning given to it in regulation 3A;

(f) omit the definition of “harmonised standard”;

(g) for the definition of “importer” substitute—

“importer” means a person who— (a) is established in the United Kingdom and places a toy from a country outside of the United Kingdom on the market; or (b) is established in Northern Ireland and places a toy on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;

(h) in the definition of “make available on the market” for “EU market” substitute “market of Great Britain”;

(i) for the definition of “Module” substitute—

“Module” means a Module set out in Schedule 6 and Module A, B or C is to be construed accordingly;

(j) omit the definition of “notified body designation”;

(k) in the definition of “place on the market” for “EU market” substitute “market of Great Britain”;

(l) after the definition of “place on the market” insert—

“RAMS” means Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;

(m) after the definition of “toy” insert—

“UK marking” means the marking in the form set out in Annex 2 of RAMS; “UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;

(n) omit the definition of “UK notified body”.

Insertion of Regulations 3A and 3B

5

After regulation 3, insert—

(3A) (1) Subject to paragraphs (6) and (7) in these Regulations a “designated standard” means a technical specification which is— (a) adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory; and (b) designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate; (2) For the purposes of subparagraph (a), a “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one of more of the following— (a) the characteristics required of a product including— (i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and (ii) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; or (b) production methods and processes relating to the products, where these have an effect on their characteristics; (3) For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations— (a) the European Committee for Standardisation (CEN); (b) the European Committee for Electrotechnical Standardisation (Cenelec); (c) the European Telecommunications Standards Institute (ETSI); (d) the British Standards Institution (BSI); (4) When considering whether the manner of publication of a reference in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard; (5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with technical specifications adopted by the other recognised standardisation organisations; (6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b). (7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard. (8) In this regulation a reference to a “product” is a reference to a toy to which these Regulations apply (9) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies. (10) Regulations made under paragraph (9) are to be made by statutory instrument. (11) A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament. (3B) (1) Schedules 1, 2, 4 and 5 reproduce provisions of the Annexes I, II, IV and V (respectively) to the Directive with amendments to correct deficiencies in retained EU law. (2) A reference to a provision of Schedules 1, 2, 4, 5 is a reference to the equivalent provision of the relevant Annex to the Directive as set out in the relevant Schedule. (3) Schedule 6 reproduces provisions of Annex II to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (“Decision No 768/2008/EC”) which are relevant to these Regulations, as it has effect immediately before IP completion day, with amendments to correct deficiencies in retained EU law. (4) A reference to a provision of Schedule 6 is a reference to the equivalent provision of Annex II of Decision No 768/2008/EC as set out in that Schedule.

Amendment to regulation 4

6

In regulation 4 (toys to which these Regulations apply) in paragraph (3)(f) for “Annex I to the Directive” substitute “ Schedule 1 ”.

Amendment to regulation 5

7

In regulation 5(1)(b) (essential safety requirement) for “Annex II to the Directive (as amended from time to time)” substitute “ Schedule 2 ”.

Omission of regulation 6

8

Regulation 6 (toys placed on the market before 20th July 2013) is omitted.

Amendment to regulation 7

9

In regulation 7 (presumption of conformity) for “harmonised” substitute “ designated ”.

Amendment to regulation 8

10

In regulation 8 (exception for trade fairs or exhibitions)—

(a) in paragraph (1) for “CE” substitute “ UK ”;

(b) in paragraph (2) in both places in which it occurs for “the Directive” substitute “ these Regulations ”;

Amendment to regulation 10

11

In regulation 10 (prohibitions on placing toys on the market) in paragraph (2)(d)—

(a) omit “EC”;

(b) for “CE” substitute “ UK ”.

Amendment to regulation 13

12

In regulation 13 (applicable conformity assessment procedures)—

(a) in paragraphs (2) and (3)(a) to (c) for “harmonised” substitute “ designated ”;

(b) in paragraph (3) for “EC-type” substitute “ Type ”.

Amendment to regulation 14

13

In regulation 14 (application for EC-type examination)—

(a) in the heading and in the regulation for “EC-type” substitute “ Type ”

(b) in paragraph (a) for “a notified” substitute “ an approved ”;

(i) omit the words beginning with “if” and ending with “UK notified body,”;

(ii) for “by UK notified” substitute “ by approved ”.

Amendment to regulation 15

14

In regulation 15 (EC declaration of conformity and CE marking)—

(a) in the heading—

(i) for “EC declaration” substitute “ Declaration ”; and

(ii) for “CE” substitute “ UK ”;

(b) in paragraph (a) for “an EC” substitute “ a ”;

Amendment to regulation 16

15

In regulation 16—

(a) omit “EC” in each place in which it occurs;

(b) in paragraph 2(a) for “Annex III to the Directive” substitute “ Schedule 3 ”;

Amendment to regulation 17

16

In regulation 17 (technical documentation and correspondence)—

(a) in the heading for “EC-type” substitute “ Type ”;

(b) for paragraph (2) substitute—

(2) The technical documentation must be drawn up in English.

(d) for paragraph (4) substitute—

(4) Any correspondence relating to the Type examination of a toy must be drawn up in English.

(e) in paragraph (5) omit “EC”;

(f) in paragraph (10)—

(i) for “a notified” substitute “ an approved ”;

(ii) for “the notified” substitute “ the approved ” in both places in which it occurs;

(iii) for “harmonised” substitute “ designated ”.

Amendment to regulation 18

17

In regulation 18 (Toys to bear CE marking)—

(a) in the heading and in each place in which it occurs for “CE” substitute “ UK ”;

(b) after paragraph (3) insert—

(3A) For a period of 24 months beginning with IP completion day, the manufacturer may, in place of affixing the UK marking in accordance with paragraph (3) affix the UK marking to a document accompanying the toy.

Amendment to regulation 20

18

In regulation 20 (instructions for use, safety information and warnings)—

(a) omit paragraph (10);

(b) in each place in which it occurs for “Annex V to the Directive” substitute “ Schedule 5 ”.

Amendment to regulation 21

19

In regulation 21(2)(b) (compliance procedures for series production)—

(a) for “harmonised” substitute “ designated ”;

(b) omit “EC”.

Amendment to regulation 22

20

In regulation 22 (submission of EC-type examination certificate for review)—

(a) in the heading for “EC-type” substitute “ Type ”;

(b) for “An EC-type” substitute “ A Type ”;

Amendment to regulation 25

21

In regulation 25 (manufacturer's authorised representative)—

(a) in paragraph (1) for “within the EU” substitute “ in the United Kingdom ”;

(b) in paragraph (2)(a) omit “or translation”.

Amendment to regulation 26

22

Regulation 26 (prohibitions on placing toys on the market) in paragraph 2(a)(iii) for “CE” substitute “ UK ”.

Amendment to regulation 27

23

In regulation 27 (information identifying importer) for paragraph (2) substitute—

(2) Paragraph (1) does not apply where— (a) either— (i) the size or nature of the toy precludes the information from being marked on the toy; (ii) the importer would have to open the toy's packaging in order to mark the information on the toy; or (iii) the importer imported the toy from an EEA state or Switzerland and places it on the market within the period of 24 months beginning with IP completion day; and (b) the importer ensures that the information referred to in paragraph (1) is set out on the toy's packaging or in a document accompanying the toy.

Amendment to regulation 31

24

In regulation 31 (duties to retain and provide information) omit “EC”.

Amendment to regulation 33

25

In regulation 33 (duty to act with due care and prohibitions) in paragraph (3)(a)(i) for “CE” substitute “ UK ”.

Amendment to regulation 39

26

In regulation 39 (protection of CE marking)—

(a) in the heading and in each place in which it occurs for “CE” substitute “ UK ”;

(b) in paragraph (1)(a)(ii) omit “in accordance with regulation 25(1)”.

Insertion of regulation 39A and Part 2A

27

After regulation 39 insert—

(39A) (1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive; (b) “CE marking” has the meaning given to it in Article 3(16); (c) “harmonised standard” has the meaning given to it in Article 3(8); (2) Subject to paragraphs (6) and (7) paragraph (3) applies where, before placing a toy on the UK market, a manufacturer— (a) ensures that the toy has been designed and manufactured in accordance with the requirements set out in— (i) in Article 10 (essential safety requirements); and (ii) Annex II (particular safety requirements); (b) carries out the safety assessment in accordance with Article 18; (c) ensures that the relevant conformity assessment procedure has been carried out in accordance with Article 19; (d) in cases where the manufacturer considers that Article 19(3) applies, ensures that the provisions of Article 20 are complied with; (e) draws up the technical documentation in accordance with Article 21(1); (f) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English; (g) affixes the CE marking in accordance with Articles 16 and 17; (h) draws up an EC declaration of conformity, in accordance with Article 15; and (i) ensures that the EC declaration of conformity is prepared in or translated into English. (3) Where this paragraph applies— (a) the requirements of regulations 10 to 15, 16(1) to (2), 17(1) to (4) and 18, are to be treated as being satisfied; (b) regulations 16(4) to (5), 17(5) and (10), 21, 22, 39 and 44 are to be read subject to the modifications in paragraph (10); (c) regulations 42 to 44 do not apply; and (d) regulation 52 does not apply. (4) Subject to paragraphs (6) and (7), paragraph (5) applies, where before placing a toy on the market, the importer ensures that— (a) the relevant conformity assessment procedure that applies to that toy has been carried out in accordance with Article 19; (b) the manufacturer has drawn up the technical documentation in accordance with Article 21(1); and (c) the toy bears the CE marking affixed in accordance with Articles 16 and 17. (5) Where this paragraph applies— (a) the requirements in regulation 26(a)(i) to (iii) are to be treated as being satisfied; and (b) regulations 26(1), 28 and 30 to 32 are to be read subject to the modifications in paragraph (10). (6) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard. (7) Where paragraph (6) applies paragraphs (2)(c) and (4)(a) are to be treated as requiring the manufacturer to carry out the conformity assessment procedure referred to in Article 19(3). (8) Paragraph (9) applies where before making a toy available on the market, a distributor ensures that the manufacturer has affixed the CE marking in accordance with Articles 16 and 17. (9) Where this paragraph applies— (a) regulation 33(3)(a)(i) is to be treated as being satisfied; (b) regulation 33(2), 34, 35 and 37 are to be read subject to the modifications in paragraph (10). (10) The modifications referred to in paragraphs (3)(b), (5)(b) and (9)(b) are that— (a) any reference to “declaration of conformity” is to be read as a reference to the EC declaration of conformity; (b) any reference to “UK marking” is to be read as a reference to the CE marking; (c) any reference to “essential safety requirements” is to be read as a reference to the requirements set out in— (i) in Article 10 (essential safety requirements); and (ii) Annex II (particular safety requirements); (d) any reference to “designated standard” is to be read as a reference to a harmonised standard; (e) any reference to “applicable conformity assessment procedure” is to be read as a reference to the applicable conformity assessment procedures referred to in Article 19; (f) any reference to “technical documentation” is a reference to the technical documentation referred to in Article 21(1); (g) any reference to “authorised representative” is a reference to a person appointed in accordance with Article 5; and (h) any reference to “Type examination” is a reference to “EC-type examination”. (39AA) (1) Subject to paragraph (2), regulation 39A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 39A— (a) any toy which was placed on the market pursuant to regulation 39A may continue to be made available on the market on or after the expiry of regulation 39A; (b) any obligation to which a person was subject under regulation 39A in respect of a toy placed on the market pursuant to regulation 39A continues to have effect after the expiry of regulation 39A, in respect of that toy. (39AB) (1) Where paragraph (2) applies— (a) a toy is to be treated as being in conformity with the essential safety requirements; and (b) each relevant economic operator is to be treated as having complied or as complying with the obligations imposed on them under Part 2. (2) This paragraph applies where— (a) a toy is— (i) in conformity with the essential safety requirements, within the meaning of regulation 3 as it applies in Northern Ireland; and (ii) qualifying Northern Ireland goods; (b) each relevant economic operator has complied or is complying with the obligations imposed on them under Part 2, as that Part applies in Northern Ireland; and (c) an importer has complied with the obligations set out in paragraph (3). (3) The obligations referred to in paragraph (2)(c) are that, before placing the toy on the market, the importer— (a) complies with regulation 27; (b) ensures that— (i) the applicable conformity assessment procedure has been carried out; (ii) the manufacturer has drawn up the technical documentation; and (iii) the toy bears the CE marking. (4) In this regulation— - “applicable conformity assessment procedure” means the conformity assessment procedure applicable to the toy under regulation 15, as it applies in Northern Ireland; - “CE marking” has the meaning given to it in regulation 3, as it applies in Northern Ireland; - “qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018; - “technical documentation” means the technical documentation that a manufacturer has to draw up in accordance with regulation 17, as it applies in Northern Ireland. (39B) (1) The Secretary of State may by regulations amend the provision of the Schedules referred to in paragraph (2) where the Secretary of State considers it necessary to do so in order to take technical progress and scientific developments into account. (2) The provisions referred to in paragraph (1) are— (a) any provision in Schedule 1; (b) points 11 and 13 of Part 3 of Schedule 2; and (c) any provision of Schedule 5. (3) The power to make regulations made under paragraph (1) includes power— (a) to make different provisions for different cases; and (b) to make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate. (4) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament. (39C) (1) The Secretary of State may by regulations amend Appendix C to Schedule 2 to add specific values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth. (2) Regulations made under paragraph (1) may— (a) make different provisions for different cases; and (b) make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate. (3) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament. (39D) (1) Where the conditions set out in paragraph (3)(a) and (b) are met, the Secretary of State may by regulations amend Appendix A to Schedule 2 to allow substances or mixtures classified as carcinogenic, mutagenic or toxic for reproduction of the categories laid down in Section 4 of Appendix B of Schedule 2 to be used in toys, in components of toys or micro-structurally distinct parts of toys. (2) Where the conditions set out in paragraphs (3)(a), (b) and (c) are met, the Secretary of State may by regulations amend Appendix A to Schedule 2 to allow substances or mixtures classified as carcinogenic, mutagenic or toxic for reproduction of the categories laid down Section 3 of Appendix B of Schedule 2 to be used in toys, in components of toys or micro-structurally distinct parts of toys. (3) The conditions referred to in paragraphs (1) and (2) are— (a) the Secretary of State considers that there is sufficient scientific evidence to demonstrate that the use of substances or mixtures that are classified as carcinogenic, mutagenic or toxic for reproduction of the categories laid down in Section 5 of Appendix B to Schedule 2 are safe for use in toys, particularly in view of exposure; (b) the substance or mixture is not prohibited for use in consumer articles by Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) establishing a European Chemicals Agency, amending Directive 19999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/105/EC and 2000/21/EC. (c) there are no suitable alternative substances or mixtures available, as documented in an analysis of alternatives; and (4) Regulations made under paragraph (1) or (2) may— (a) make different provisions for different cases; and (b) make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate. (5) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament. (6) The Secretary of State must— (a) carry out a review of regulations made under paragraph (1) or (2); (b) set out the conclusions of the review in a report; and (c) publish the report. (7) A review to which paragraph (6) refers must be made— (a) as soon as any safety concerns arise; and (b) at intervals not exceeding five years beginning with the date regulations made under paragraph (1) or (2) come into force. (39E) (1) The Secretary of State must— (a) evaluate the occurrence of hazardous substances of materials in toys; (b) set out the conclusions of the evaluation in a report; and (c) publish the report. (2) During the evaluation the Secretary of State must consult— (a) any enforcement authority which is not the Secretary of State; and (b) any person that the Secretary of State considers appropriate. (3) The first report must be published before the end of the period of five years beginning on IP completion day. (4) Subsequent reports are to be published at intervals not exceeding five years.

Substitution of Part 3

28

For Part 3, substitute—

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