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The Conformity Assessment (Mutual Recognition Agreements) Regulations 2019

S.I. 2019/392 · Made 28 February 2019 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 31 December 2020.

Health And Safety

Consumer Protection

Made 28th February 2019

Laid before Parliament 28th February 2019

Coming into force 22nd March 2019

The Secretary of State has been designated for the purposes of making Regulations under section 2(2) of the European Communities Act 1972 M1 in relation to the matters specified in the Schedule.

The Secretary of State, in exercise of the powers conferred by section 2(2) of the European Communities Act 1972, makes the following Regulations.

Annotations to the whole text

Marginal citations

M1

1972 c. 68; section 2(2) was amended by section 27(1) of the Legislative and Regulatory Reform Act 2006 (c. 51) and by Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c. 7). It is prospectively repealed by section 1 of the European Union (Withdrawal) Act 2018 (c. 16), with effect from exit day (see section 20 of that Act).

Contents

  1. 1Citation and commencement
  2. 2Interpretation
  3. 3Recognition of conformity assessments etc.
  4. 4Recognition of authorised representatives established in Switzerland
  5. 5Recognition of authorised representatives established in Turkey
  6. 6Recognition of importers established in Switzerland Repealed
  7. Signature
  8. Schedule: Matters in relation to which the Secretary of State has been designated
  9. 1Paragraph 1
  10. 2Paragraph 2
  11. 3Paragraph 3
  12. 4Paragraph 4
  13. 5Paragraph 5
  14. 6Paragraph 6
  15. 7Paragraph 7
  16. 8Paragraph 8
  17. 9Paragraph 9
  18. 10Paragraph 10
  19. 11Paragraph 11
  20. 12Paragraph 12
  21. 13Paragraph 13
  22. 14Paragraph 14
  23. 15Paragraph 15
  24. 16Paragraph 16
  25. 17Paragraph 17
  26. 18Paragraph 18
  27. 19Paragraph 19
  28. 20Paragraph 20
  29. 21Paragraph 21
  30. 22Paragraph 22
  31. 23Paragraph 23
  32. 24Paragraph 24
  33. 25Paragraph 25
  34. 26Paragraph 26
  35. 27Paragraph 27
  36. 28Paragraph 28
  37. 29Paragraph 29
  38. 30Paragraph 30
  39. 31Paragraph 31
  40. 32Paragraph 32
  41. 33Paragraph 33
  42. 34Paragraph 34
  43. 35Paragraph 35
  44. 36Paragraph 36
  45. 37Paragraph 37
  46. Explanatory note

1Citation and commencementI1

These Regulations may be cited as the Conformity Assessment (Mutual Recognition Agreements) Regulations 2019 and come into force on 22nd March 2019.

2InterpretationI1

In these Regulations—

(a)

“attestation of conformity” means, in relation to a product, process or service, any of the following—

(i)

the results of any conformity assessment carried out in respect of the product, process or service;

(ii)

a report, certificate, authorisation, decision or a mark of conformity relating to such an assessment;

(iii)

a declaration of conformity;

(iv)

the confirmation (within the meaning given by Article 1(1)(f) of the Japanese agreement) of manufacturing facilities;

(b)

“conformity assessment” means systematic examination to determine the extent to which a product, process or service fulfils specified requirements;

(c)

“Israeli agreement” means the agreement mentioned in sub-paragraph (e)(xi);

(d)

“Japanese agreement” means the agreement mentioned in sub-paragraph (e)(vi);

(e)

“mutual recognition agreement” means—

(i)

the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia M1;

(ii)

the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand M2;

(iii)

the Protocol on the mutual acceptance of the results of conformity assessment, which is part of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part M3;

(iv)

the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products, which is part of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part M4;

(v)

the Agreement on mutual recognition between the European Community and the United States of America M5;

(vi)

the Agreement on mutual recognition between the European Community and Japan M6;

(vii)

the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment M7;

(viii)

the Agreement between the European Community and the United States of America on the Mutual Recognition of Certificates of Conformity for Marine Equipment M8;

(ix)

Decision No. 1/2006 of the EC-Turkey Association Council of 15 May 2006 on the implementation of Article 9 of Decision No. 1/95 of the EC-Turkey Association Council on implementing the final phase of the Customs Union M9;

(x)

Annex 2-B to the Free Trade Agreement between the European Union and its Member States, of the one part, and the Republic of Korea, of the other part M10; or

(xi)

the Protocol to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on Conformity Assessment and Acceptance of Industrial Products (CAA) M11;

(f)

“Swiss agreement” means the agreement mentioned in sub-paragraph (e)(vii);

(g)

“Turkish agreement” means the decision mentioned in sub-paragraph (e)(ix).

3Recognition of conformity assessments etc.I1

(1)

Subject to paragraph (10), paragraph (2) applies where, pursuant to a mutual recognition agreement, member States are required to recognise or accept an attestation of conformity with the relevant European Union law in respect of a product, process or service (a “mutually recognised attestation of conformity”).

(2)

Where this paragraph applies, the mutually recognised attestation of conformity is to be treated as if it were an attestation of conformity issued under the updated relevant European Union law by a person authorised or required to issue such attestations in respect of the product, process or service.

(3)

Subject to paragraph (10), paragraph (4) applies where, pursuant to Article 1(2) of the Swiss agreement, member States are required to accept an attestation of conformity with the relevant Swiss law in respect of a product, process or service (a “Swiss enhanced attestation of conformity”).

(4)

Where this paragraph applies—

(a)

compliance with requirements of the updated relevant Swiss law in respect of the product, process or service is to be treated as compliance with the equivalent requirements of the updated relevant European Union law; and

(b)

the Swiss enhanced attestation of conformity is to be treated as if it were an attestation of conformity issued under the updated relevant European Union law by a person authorised or required to issue such attestations in respect of the product, process or service.

(5)

Subject to paragraph (10), paragraph (6) applies where, pursuant to Article 2(3) of the Turkish agreement, member States are required to accept an attestation of conformity with the relevant Turkish law in respect of a product (a “Turkish enhanced attestation of conformity”).

(6)

Where this paragraph applies—

(a)

compliance with requirements of the updated relevant Turkish law in respect of the product is to be treated as compliance with the equivalent requirements of the updated relevant European Union law; and

(b)

the Turkish enhanced attestation of conformity is to be treated as if it were an attestation of conformity issued under the updated relevant European Union law by a person authorised or required to issue such attestations in respect of the product.

(7)

Subject to paragraph (10), paragraph (8) applies where, pursuant to Article 5(3) of the Israeli agreement, member States are required to accept an attestation of conformity with the relevant Israeli law in respect of a product (an “Israeli enhanced attestation of conformity”).

(8)

Where this paragraph applies—

(a)

compliance with requirements of the relevant Israeli law in respect of the product is to be treated as compliance with the equivalent requirements of the relevant European Union law; and

(b)

the Israeli enhanced attestation of conformity is to be treated as if it were an attestation of conformity issued under the relevant European Union law by a person authorised or required to issue such attestations in respect of the product.

(9)

In this regulation—

(a)

“relevant European Union law”, in respect of a mutual recognition agreement as it relates to a product, process or service, means the European Union law in respect of that product, process or service which is specified, or otherwise referred to, in or under the mutual recognition agreement;

(b)

“relevant Israeli law”, in respect of a product, means any provision of Israeli law in respect of that product which is specified in a notification under the Annex to the Israeli agreement;

(c)

“relevant Swiss law”, in respect of a product, process or service, means the Swiss law in respect of that product, process or service which is specified in the Swiss agreement;

(d)

“relevant Turkish law”, in respect of a product, means any provision of Turkish law that reproduces the effect of any provision of relevant European Union law in respect of that product (as specified in a statement adopted as mentioned in Article 1(1) of the Turkish agreement);

(e)

“updated relevant European Union law”, in respect of a mutual recognition agreement as it relates to a product, process or service, means the relevant European Union law as amended or re-enacted (with or without modifications) before the day on which these Regulations are made (whether or not those amendments or re-enactments are specified, or otherwise referred to, in or under the mutual recognition agreement as it had effect immediately before that day);

(f)

“updated relevant Swiss law”, in respect of a product, process or service, means the relevant Swiss law as amended or re-enacted (with or without modifications) before the day on which these Regulations are made (whether or not those amendments or re-enactments are specified in the Swiss agreement as it had effect immediately before that day);

(g)

“updated relevant Turkish law”, in respect of a product, means any provision of Turkish law that reproduces the effect of any updated relevant European Union law in respect of that product.

(10)

Any provision made by paragraph (2), (4), (6) or (8) (a “default provision”) does not apply in respect of a product, process or service at any time if, at that time, there is sector specific provision in force.

(11)

In paragraph (10), “sector specific provision”, means provision in respect of the product, process or service, which is of similar effect to the default provision in question.

4Recognition of authorised representatives established in SwitzerlandI1

(1)

This regulation applies in respect of the product sectors listed in Chapters 2, F14 to 11, 16, 17, 19 and 20 of Annex 1 to the Swiss agreement (“the specified product sectors”).

(2)

Any person established in Switzerland is to be treated as established in a member State for the purpose of determining whether that person is, or is eligible to be appointed as, the authorised representative of a manufacturer.

(3)

In paragraph (2), “authorised representative” means a person who has received a written mandate from a manufacturer to perform specified tasks on the manufacturer's behalf pursuant to the updated relevant European Union law or the updated relevant Swiss law in respect of the specified product sector concerned.

(4)

In paragraph (3), “updated relevant European Union law” and “updated relevant Swiss law” have the meanings given in regulation 3(9).

5Recognition of authorised representatives established in TurkeyI1

(1)

This regulation applies where a statement, adopted as mentioned in Article 1(1) of the Turkish agreement, recommends implementation of the principle of mutual recognition of the rights of authorised representatives in respect of any product to which the statement relates (“the relevant product”).

(2)

Any person established in Turkey is to be treated as established in a member State for the purpose of determining whether that person is, or is eligible to be appointed as, the authorised representative of a manufacturer.

(3)

In this regulation, “authorised representative” means a person who has received a written mandate from a manufacturer to perform specified tasks on the manufacturer's behalf in accordance with the updated relevant European Union law or the updated relevant Turkish law in respect of the relevant product concerned.

(4)

In paragraph (3), “updated relevant European Union law” and “updated relevant Turkish law” have the meanings given in regulation 3(9).

6Recognition of importers established in SwitzerlandF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Signature

Kelly Tolhurst

Parliamentary Under Secretary of State

Department for Business, Energy and Industrial Strategy

1I1

Regulation of the type, description, construction or equipment of vehicles, and of components of vehicles, and in particular any vehicle type approval scheme M1.

2I1

Measures for safety as respects electrical equipment M1.

3I1

Medicinal products M1.

4I1

The regulation of specifications, construction, placing on the market and use of articles, instruments, containers or other equipment intended for weighing, measuring or testing or for purposes ancillary thereto, including, in particular—

(a)

approval of patterns and the verification of conformity with patterns or other requirements;

(b)

authentication and proof of such approval or verification or of exemption from the need for approval or verification;

(c)

supervision and enforcement of compliance with requirements M1.

5I1

Units of measurement to be used for economic, health, safety or administrative purposes and the prefixes to be used with such units M1.

6I1

Measures relating to safety as regards simple pressure vessels M1.

7I1

Measures relating to the approval of telecommunications terminal equipment M1.

8I1

Measures relating to construction products M1.

9I1

Measures relating to apparatus which is liable to cause electromagnetic disturbance and to apparatus the performance of which is liable to be affected by such disturbance M1.

10I1

Measures relating to safety as regards personal protective equipment M1.

11I1

Measures relating to safety as regards appliances burning gaseous fuels M1.

12I1

Measures relating to active implantable medical devices M1.

13I1

Measures relating to efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels M1.

14I1

Regulation of the type, description, construction or equipment of agricultural or forestry tractors and of their components, and in particular any type approval scheme for such tractors M1.

15I1

Measures relating to the safety of ships and the health and safety of persons on them M1.

16I1

Measures relating to medical devices other than active implantable medical devices M1.

17I1

Measures relating to the placing on the market, transfer and safety of explosives for civil use M1.

18I1

Measures relating to consumer protection M1.

19I1

Measures relating to maritime transport M1.

20I1

Measures relating to equipment and protective systems intended for use in potentially explosive atmospheres M1.

21I1

Measures relating to craft intended for recreational purposes M1.

22I1

Measures relating to the transport of dangerous or environmentally hazardous goods by road or rail M1.

23I1

Measures relating to lifts and the safety components for use in lifts M1.

24I1

Measures relating to pressure equipment and assemblies of pressure equipment M1.

25I1

Measures in the veterinary and phytosanitary fields for the protection of public health M1.

26I1

Measures relating to biocides M1.

27I1

Measures relating to wireless telegraphy including radio equipment M1.

28I1

Matters in respect of noise emission in the environment by equipment for use outdoors M1.

29I1

Cableway installations designed to carry people and components of such installations M1.

30I1

The restriction of the use of hazardous substances in electrical and electronic equipment M1.

31I1

Health protection measures regulating the use of material of human origin M1.

32I1

The regulation, labelling and control of packages and products made up to a pre-determined constant nominal quantity, whether that be weight, volume, number, area, length or any other measurement M1.

33I1

Machinery, including—

(a)

component parts of machines;

(b)

components or equipment to be attached to or used with machines; and

(c)

sub-assemblies to be incorporated into or assembled with machines M1.

34I1

The packaging of products M1.

35I1

Pyrotechnic articles M1.

36I1

Market surveillance and marking which indicates that a product is in conformity with requirements of EU legislation M1.

37I1

The environmental aspects of product design M1.

Explanatory note

(This note is not part of the Regulations)

These Regulations implement the following agreements between the European Union and third countries (“the mutual recognition agreements”)—

  1. (a)

    the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia;

  2. (b)

    the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand;

  3. (c)

    the Protocol on the mutual acceptance of the results of conformity assessment, which is part of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part;

  4. (d)

    the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products, which is part of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part;

  5. (e)

    the Agreement on mutual recognition between the European Community and the United States of America;

  6. (f)

    the Agreement on mutual recognition between the European Community and Japan;

  7. (g)

    the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (“the Swiss agreement”);

  8. (h)

    the Agreement between the European Community and the United States of America on the Mutual Recognition of Certificates of Conformity for Marine Equipment;

  9. (i)

    Decision No. 1/2006 of the EC-Turkey Association Council of 15 May 2006 on the implementation of Article 9 of Decision No. 1/95 of the EC-Turkey Association Council on implementing the final phase of the Customs Union (“the Turkish agreement”);

  10. (j)

    Annex 2-B to the Free Trade Agreement between the European Union and its Member States, of the one part, and the Republic of Korea, of the other part;

  11. (k)

    the Protocol to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on Conformity Assessment and Acceptance of Industrial Products (CAA) (“the Israeli agreement”).

The mutual recognition agreements require member States to accept attestations of conformity issued by third countries in respect of certain products, processes or services. A third country's attestation of conformity confirms that the product, process or service concerned complies with the requirements of European Union law which apply to that product, process or service and which are referred to in the mutual recognition agreement concerned. Regulation 3(2) of these Regulations requires the United Kingdom to accept such attestations of conformity.

Article 1(2) of the Swiss agreement also requires member States to accept an attestation of conformity issued by Switzerland, where the attestation confirms that Switzerland has complied with the requirements of Swiss law which are equivalent to the requirements of European Union law in respect of a product, process or service. Regulation 3(4) of these Regulations provides that the United Kingdom must accept such attestations of conformity.

Article 2(3) of the Turkish agreement requires member States to accept an attestation of conformity issued by Turkey in respect of a product, in cases where the Customs Union Joint Committee has adopted a statement confirming that Turkey has put into force the European Union law in respect of that product. Regulation 3(6) of these Regulations implements that requirement.

Article 5(3) of the Israeli agreement requires member States to accept an attestation of conformity issued by Israel in respect of a product, in cases where Israel has complied with provisions of Israeli law which align with any provision of European Union law in respect of that product which has been specified in a notification under the Annex to the Israeli agreement. Regulation 3(8) of these Regulations implements that requirement.

Regulation 4 of these Regulations implements the provisions in the Swiss agreement that allow a Swiss manufacturer to appoint an authorised representative who is established in the European Union or in Switzerland.

Regulation 5 of these Regulations makes similar provision in relation to authorised representatives who are established in Turkey.

An impact assessment has not been published for this instrument as it has no or no significant impact on the private, public and voluntary sectors.