CONSUMER PRODUCT SAFETY CONSUMER PRODUCT SAFETY

REGULATIONREGULATION

ING. THOMAS CONSOLI B. Eng. (Hons).

29 MAY 2013

Presentation Outline

• Introduction• Aim• Main changes compared with GPSD• Scope of the Proposed Regulation• General Safety Requirement• Presumption of Safety• Product Safety Assessment• Indication of Country of Origin• Obligations of Economic Operators

– Identification of Product– Technical Documentation– Information Obligation– Identification of Economic Operators– Traceability

• Standard Setting Procedures• Penalties

Ing. Thomas Consoli

Introduction

• Proposed Regulation will replace Directive 2001/95/EC (the GPSD) and will repeal Directive 87/357/EEC (on food-imitating products)

• Very important because it deals with the free movement of safe consumer products.

• The proposed Regulation and its interface with other Union legislation will be significantly streamlined and simplified whilst maintaining a high level of protection of the health and safety of consumers.

Ing. Thomas Consoli

Aim

• This proposal aims at clarifying the regulatory framework for consumer products taking into account legislative developments in recent years; which are:

– the New Legislative Framework (Regulation (EC) No 765/2008 and Decision No 768/2008/EC)

– the alignment of sector-specific harmonised legislation to this Framework

– the New Regulation on European standardisation (Regulation (EU) No 1025/2012)

Ing. Thomas Consoli

Main Changes (1/2)

• The proposal is a Regulation (not Directive). This will mean that the new legal instrument will be directly applicable in all Member States and avoid any conflicting transpositions.

• The delimitation of the scope of application compared to sector-specific harmonised legislation in the proposed Regulation has been made clearer than in the current GPSD. In fact:– General principle that all products must be safe applies to all products

– The more detailed obligations on economic operators only apply to those operators that are not subject to corresponding obligations laid down in harmonising legislation covering a specific product sector.

• Manufacturers and importers will be required to ensure that products bear an indication of the country of origin.

Ing. Thomas Consoli

Main Changes (2/2)

• Products to which consumers are exposed in the context of a service provided to them have been clearly included within scopeof the proposed Regulation.

• Importers will be required to indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product.

• More important role for Distributors - Distributors will be required to verify that that the product is appropriately labelled and isaccompanied by the necessary instructions.

• The provisions regarding market surveillance and RAPEX that are currently contained in the GPSD have been transferred to the proposal for a new single Market Surveillance Regulation.

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Scope of the Proposed Regulation

• Chapter I: All Consumer products

• The scope includes all products:

– which are intended for consumers;

– which are likely to be used by consumers even if not intended for them;

– to which consumers are exposed in the context of a service provided to them.

• It excludes:

– products to be repaired or reconditioned prior to being used where those products are made available on the market as such.

– Products listed in Article 2(3) – food, feed, medicines, food-contact materials, animal by-products, plant protection products, equipment on which consumers ride, antiques.

Ing. Thomas Consoli

Scope of the Proposed Regulation

• Chapters II to IV: Non-harmonised consumer

products only

The following topics covered in the proposed Regulation therefore

only apply to products that are not subject to sector-specific

harmonised legislation:

– Obligations of Economic Operators

– European Standards providing Presumption of Conformity

– Final Provisions

Ing. Thomas Consoli

General Safety Requirement

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Article 4: Economic operators shall place or make available on the Union market only

safe products.

• Safe Product - any product which, under normal or

reasonably foreseeable conditions of use of the product

concerned, including the duration of use and, where

applicable, its putting into service, installation and

maintenance requirements, does not present any risk or only

the minimum risks compatible with the product's use,

considered acceptable and consistent with a high level of

protection of health and safety of persons

Presumption of Safety

• Article 5: Product shall be presumed to be safe if it conforms to:

(a) Requirements designed to protect human health and safety laid down in or pursuant to harmonised legislation

(b) Relevant European standards the references of which have been published in the OJEU (in the absence if (a))

(c) National requirements laid down in the law of the Member State where the product is placed on the market (in the absence of (a) and (b))

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Assessing product Safety (1/3)

• Article 6: In the absence of harmonised legislation,

harmonised standards and national laws; the following

shall be considered when assessing whether a product is

safe:

– Product characteristics

– Effect on other products (if reasonably foreseeable

that will be used with other products)

– Presentation of product, labelling, warnings, etc

– Categories of consumers at risk when using products

– Appearance of product (is it food imitating?)

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Assessing product Safety (2/3)

• When available, the following aspects shall be

considered:

– the state of the art and technology;

– European standards (not harmonised)

– international standards

– international agreements

– Commission recommendations or guidelines on product

safety assessment

– national standards

– product safety codes of good practice

– reasonable consumer expectations concerning safety

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Assessing product Safety (3/3)

• The feasibility of obtaining higher levels of safety or the

availability of other products presenting a lesser degree

of risk shall not constitute grounds for considering a

product not to be safe.

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Indication of Country of Origin

• Article 7: Manufacturers and importers shall ensure that

products bear an indication of the country of origin of

the product

• Non-preferential origin rules set out in Articles 23 to 25

of Council Regulation (EEC) No 2913/92 establishing a

Community Customs Code shall apply.

• Where the country of origin is a Member State of the

Union, manufacturers and importers may refer to the

Union or to a particular Member State.

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Obligations of Economic Operators

• Responsibilities of economic operators have been

aligned with those provided in Decision 768/2008.

• Article 8 - Obligations of Manufacturers

• Article 10 - Obligations of Importers

• Article 11 - Obligations of Distributors

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Identification of the Product

• Article 8: Manufacturers

– ensure that their products bear a type, batch or serial number

– indicate their name, registered trade name or registered trade

mark and the address at which they can be contacted

• Article 10: Importers

– Verification of labelling (identification of product and

manufacturer)

– indicate their name, registered trade name or registered trade

mark and the address at which they can be contacted on the

product

– They shall ensure that any additional label does not obscure any

information on the label provided by the manufacturer.

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Technical Documentation

• Technical Documentation shall contain:

– General description of product and its essential properties

relevant to assess its safety

– Analysis of risks and solutions adopted to mitigate such

risks, including outcome of any tests

– List of standards or other technical requirements applied

to meet the general safety requirement

• It shall be proportionate to the possible risks of the product.

• It shall be kept for a period of 10 years and made available to

Market Surevillance Authorities upon request.

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Information obligation

• Articles 8(9), 10(2), 10(7), 11(3) and 11(5)

• Manufacturers, importers and distributors are obliged to

inform Market Surveillance Authorities in the Member States

in which they have made an unsafe product available on the

market

• They shall provide details of risk to health and safety and any

corrective action taken

• In Article 13(1) there are certain exceptions to this obligation.

Commission may determine the situations which fall under

this exception by means of implementing acts

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Identification of Economic operators

• Article 14: For a period of 10 years after supply of product has

occurred, economic operators shall, on request, identify the

following to the market surveillance authorities:

– any economic operator who has supplied them with the

product

– any economic operator to whom they have supplied the

product

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Traceability

• Article 15: For certain ‘high risk’ products, Commission may

require a system of traceability.

• System shall consist of the collection and storage of data by

electronic means enabling the identification of the product

and of the economic operators involved in its supply chain as

well as of the placement of a data carrier on product.

• Commission to identify:

– to which category of products this applies by means of delegated

acts.

– type of data carrier by means of implementing acts.

• In doing so, Commission must consider cost-effectiveness and

impact on SMEs

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Standard setting procedures (1/2)

• Chapter III of the proposal.

• Promotion of use of EN standards in support of general safety

requirement ('presumption of safety')

• Standardisation request ('mandate') by implementing act

– Development of standards or identification of existing standards

– Safety requirements to be included directly in the mandate

– Appropriate consultation of experts of Member States in the

field of consumer product safety

– Vote by the Committee under the Standardisation Regulation

– Reference of standard published in OJEU (no formal measure

required)

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Standard setting procedures (2/2)

• Formal Objection procedure - a Member State or the

European Parliament considers that a European standard

does not entirely satisfy the requirements it aims to cover and

the general safety requirement

• Vote on Formal Objection taken under Committee in

Standardisation Regulation

• Decision on formal objection taken by Implementing act

• Procedures aligned with Regulation 1025/2012 on European

Standardisation

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Penalties

• Penalties shall be effective, proportionate and

dissuasive.

• Penalties may include criminal sanctions for serious

infrignments.

• Penalties may be increased if the relevant economic

operator has previously committed a similar

infringement.

Ing. Thomas Consoli

Thank you for your attentionThank you for your attention

For further information, please contact:

Ing. Thomas Consoli• B. Eng. (Hons).

Regulatory Affairs Directorate

Technical Regulations Division

Malta Competition and Consumer Affairs Authority

Mizzi House, National Road,

Blata l-Bajda, Hamrun.

Tel: + (356) 23 952 225

e-mail: thomas.consoli@mccaa.org.mt

Ing. Thomas Consoli