Decision revoked (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), Sch. 2 Pt. 2 (with reg. 29(2)) (as amended by S.I. 2020/1376, regs. 1(4), 3(20)); 2020 c. 1, Sch. 5 para. 1(1); and also expressed to be revoked (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), Sch. 37 para. 1(c) (as amended by S.I. 2020/676, regs. 1(1), 3); 2020 c. 1, Sch. 5 para. 1(1)

http://www.legislation.gov.uk/eudn/2008/768Decision 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 (Text with EEA relevance) (revoked)Decision No 768/2008/EC of the European Parliament and of the CouncilDecision 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 (Text with EEA relevance)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008D0768texttext/xmlen2024-06-06Expert Participation2020-12-31

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

(Text with EEA relevance) (revoked)

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Article 1General principles

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Article 2Subject matter and scope

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Article 3Level of protection of public interests

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Article 4Conformity assessment procedures

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Article 5EC declaration of conformity

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Article 6Conformity assessment

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Article 7Reference provisions

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Article 8Repeal

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ANNEX IREFERENCE PROVISIONS FOR COMMUNITY HARMONISATION LEGISLATION FOR PRODUCTSChapter R1DefinitionsDefinitionsArticle R1

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Chapter R2Obligations of economic operatorsObligations of manufacturersArticle R2

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Authorised representativesArticle R3

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Obligations of importersArticle R4

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Obligations of distributorsArticle R5

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Cases in which obligations of manufacturers apply to importers and distributorsArticle R6

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Identification of economic operatorsArticle R7

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Chapter R3Conformity of the productPresumption of conformityArticle R8

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Formal objection to a harmonised standardArticle R9

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EC declaration of conformityArticle R10

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General principles of the CE markingArticle R11

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Rules and conditions for affixing the CE markingArticle R12

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Chapter R4Notification of conformity assessment bodiesNotificationArticle R13

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Notifying authoritiesArticle R14

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Requirements relating to notifying authoritiesArticle R15

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Information obligation on notifying authoritiesArticle R16

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Requirements relating to notified bodiesArticle R17

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Presumption of conformityArticle R18

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Formal objection to a harmonised standardArticle R19

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Subsidiaries of and subcontracting by notified bodiesArticle R20

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Accredited in-house bodiesArticle R21

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Application for notificationArticle R22

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Notification procedureArticle R23

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Identification numbers and lists of notified bodiesArticle R24

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Changes to notificationsArticle R25

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Challenge of the competence of notified bodiesArticle R26

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Operational obligations of notified bodiesArticle R27

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Information obligation on notified bodiesArticle R28

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Exchange of experienceArticle R29

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Coordination of notified bodiesArticle R30

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Chapter R5Safeguard proceduresProcedure for dealing with products presenting a risk at national levelArticle R31

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Community safeguard procedureArticle R32

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Compliant products which present a risk to health and safetyArticle R33

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Formal non-complianceArticle R34

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ANNEX IICONFORMITY ASSESSMENT PROCEDURESModule AInternal production control1.

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2.Technical documentation

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3.Manufacturing

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4.1.

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4.2.The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up.

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5.Authorised representative

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Module A1Internal production control plus supervised product testing1.

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2.Technical documentation

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3.Manufacturing

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4.Product checks

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5.1.

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5.2.The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up.

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6.Authorised representative

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Module A2Internal production control plus supervised product checks at random intervals1.

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2.Technical documentation

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3.Manufacturing

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4.Product checks

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5.1.

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6.Authorised representative

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Module BEC-type examination1.

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2.EC-type examination may be carried out in either of the following manners:

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3.The manufacturer shall lodge an application for EC-type examination with a single notified body of his choice.

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4.The notified body shall:

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4.1.examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product;

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4.2.

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4.3.

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4.4.

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4.5.

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6.Where the type meets the requirements of the specific legislative instrument that apply to the product concerned, the notified body shall issue an EC-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached.

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7.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

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8.Each notified body shall inform its notifying authorities concerning the EC-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

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10.

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Module CConformity to type based on internal production control1.

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2.Manufacturing

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3.1.

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3.2.The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up.

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4.Authorised representative

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Module C1Conformity to type based on internal production control plus supervised product testing1.

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2.Manufacturing

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3.Product checks

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4.1.

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4.2.The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up.

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5.Authorised representative

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Module C2Conformity to type based on internal production control plus supervised product checks at random intervals1.

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2.Manufacturing

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3.Product checks

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4.1.

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5.Authorised representative

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Module DConformity to type based on quality assurance of the production process1.

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2.Manufacturing

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3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

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3.2.The quality system shall ensure that the products are in conformity with the type described in the EC-type examination certificate and comply with the requirements of the legislative instrument that apply to them.

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3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

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3.4.

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3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

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4.1.

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4.2.The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

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4.3.

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4.4.

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5.1.

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5.2.The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up.

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6.The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

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7.Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

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8.Authorised representative

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Module D1Quality assurance of the production process1.

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2.Technical documentation

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4.Manufacturing

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5.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

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5.2.The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them.

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5.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2.

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5.4.

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5.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

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6.1.

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6.2.The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

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6.3.

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6.4.

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7.1.

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7.2.The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up.

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8.The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

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9.Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

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10.Authorised representative

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Module EConformity to type based on product quality assurance1.

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2.Manufacturing

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3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

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3.2.The quality system shall ensure compliance of the products with the type described in the EC-type examination certificate and with the applicable requirements of the legislative instrument.

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3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

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3.4.

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3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

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4.1.

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4.3.

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4.4.

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5.1.

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6.The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

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8.Authorised representative

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Module E1Quality assurance of final product inspection and testing1.

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2.Technical documentation

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4.Manufacturing

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5.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

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5.2.The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them.

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5.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2.

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5.4.

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5.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

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6.1.

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6.3.

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6.4.

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7.1.

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8.The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

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10.Authorised representative

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Module FConformity to type based on product verification1.

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2.Manufacturing

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3.Verification

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4.1.

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4.2.The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility.

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5.1.

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5.2.

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5.3.If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that have been found not to satisfy the tests.

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5.4.

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6.1.

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6.2.The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities, for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up.

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8.Authorised representative

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Module F1Conformity based on product verification1.

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2.Technical documentation

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3.Manufacturing

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4.Verification

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5.1.

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5.2.The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility.

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6.1.

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6.2.

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6.3.If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that have been found not to satisfy the tests.

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7.1.

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9.Authorised representative

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Module GConformity based on unit verification1.

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2.Technical documentation

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3.Manufacturing

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4.Verification

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5.1.

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5.2.The manufacturer shall draw up a written declaration of conformity and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up.

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6.Authorised representative

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Module HConformity based on full quality assurance1.

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2.Manufacturing

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3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

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3.2.The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them.

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3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

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3.4.

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3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

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4.1.

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4.2.The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

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4.3.

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4.4.

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5.1.

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6.The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

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8.Authorised representative

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Module H1Conformity based on full quality assurance plus design examination1.

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2.Manufacturing

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3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

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3.2.The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them.

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3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

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3.4.

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3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

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3.6.Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

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4.1.

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4.2.The application shall make it possible to understand the design, manufacture and operation of the product, and to assess the conformity with the requirements of the legislative instrument that apply to it. It shall include:

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4.3.The notified body shall examine the application, and where the design meets the requirements of the legislative instrument that apply to the product it shall issue an EC design examination certificate to the manufacturer. The certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. The certificate may have one or more annexes attached.

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4.4.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

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4.5.Each notified body shall inform its notifying authorities of the EC design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

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4.6.

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5.1.

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5.2.The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

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5.3.

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5.4.

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6.1.

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6.2.The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up and shall mention the number of the design examination certificate.

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7.The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

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8.Authorised representative

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TABLE: CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION

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ANNEX IIIEC DECLARATION OF CONFORMITY1.

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Signed for and on behalf of: …………………………………

(place and date of issue):

(name, function) (signature):