Legal provisions of COM(2013)78 - Consumer product safety

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dossier COM(2013)78 - Consumer product safety.
document COM(2013)78 EN
date February 13, 2013

Contents

CHAPTER I - General provisions

Article 1 - Subject matter

This Regulation lays down rules on the safety of consumer products placed or made available on the Union market.

Article 2 - Scope

1. This Regulation shall apply to products obtained through a manufacturing process placed or made available on the market, whether new, used or reconditioned, and which comply with any of the following criteria:

(a) which are intended for consumers;

(b) which are likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them;

(c) to which consumers are exposed in the context of a service provided to them.

2. This Regulation shall not apply to products to be repaired or reconditioned prior to being used where those products are made available on the market as such.

3. This Regulation shall not apply to the following:

(a) medicinal products for human or veterinary use;

(b) food;

(c) materials and articles intended to come into contact with food insofar as risks related to those products are covered by Regulation (EC) No 1935/2004 or other Union legislation applicable to food;

(d) feed;

(e) living plants and animals, genetically modified organisms and genetically modified microorganisms in contained use, as well as products of plants and animals relating directly to their future reproduction;

(f) animal by-products and derived products;

(g) plant protection products;

(h) equipment on which consumers ride or travel which is operated by a service provider within the context of a service provided to consumers;

(i) antiques.

4. Chapters II to IV of this Regulation shall not apply to products subject to requirements designed to protect human health and safety laid down in Union harmonisation legislation or pursuant to it.

Article 3 - Definitions

For the purposes of this Regulation the following definitions shall apply:

(1) ‘safe product’ means 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;

(2) ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(3) ‘placing on the market’ means the first making available of a product on the Union market;

(4) ‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured and markets that product under his name or trademark;

(5) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

(6) ‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;

(7) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

(8) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

(9) ‘European standard’ means a European standard as defined in Article 2(1)(b) of Regulation (EU) No 1025/2012;

(10) ‘international standard’ means an international standard as defined in Article 2(1)(a) of Regulation (EU) No 1025/2012;

(11) ‘national standard’ means a national standard as defined in Article 2(1)(d) of Regulation (EU) No 1025/2012;

(12) ‘European standardisation organisation’ means a European standardisation organisation as defined in Article 2(8) of Regulation (EU) No 1025/2012;

(13) ‘market surveillance authority’ means a market surveillance authority as defined in Article [3(12] of Regulation (EU) No […/…] [on market surveillance of products];

(14) ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user;

(15) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being further made available on the market;

(16) ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;

(17) ‘serious risk’ means a risk requiring rapid intervention and follow-up, including cases where the effects may not be immediate.

Article 4 - General safety requirement

Economic operators shall place or make available on the Union market only safe products.

Article 5 - Presumption of safety

For the purpose of this Regulation, a product shall be presumed to be in compliance with the general safety requirement laid down in Article 4 in the following cases:

(a) as regards the risks covered by requirements designed to protect human health and safety laid down in or pursuant to Union harmonisation legislation, if it conforms to those requirements;

(b) in the absence of requirements laid down in or pursuant to Union harmonisation legislation referred to in point (a), as regards the risks covered by European standards, if it conforms to relevant European standards or parts thereof, the references of which have been published in the Official Journal of the European Union in accordance with Articles 16 and 17;

(c) in the absence of requirements laid down in or pursuant to Union harmonisation legislation referred to in point (a) and European standards referred to in point (b), as regards the risks covered by health and safety requirements laid down in the law of the Member State where the product is made available on the market, if it conforms to such national requirements.

Article 6 - Aspects for assessing the safety of products

1. In the absence of Union harmonisation legislation, European standards or health and safety requirements laid down in the law of the Member State where the product is made available on the market as referred to in points (a), (b) and (c) of Article 5, the following aspects shall be taken into account when assessing whether a product is safe, in particular:

(a) the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;

(b) the effect on other products, where it is reasonably foreseeable that it will be used with other products;

(c) the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product;

(d) the categories of consumers at risk when using the product, in particular vulnerable consumers;

(e) the appearance of the product and in particular where a product, although not foodstuff, resembles foodstuff and is likely to be confused with foodstuff due to its form, odour, colour, appearance, packaging, labelling, volume, size or other characteristics.

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.

2. For the purpose of paragraph 1, when assessing whether a product is safe, the following aspects, when available, shall be taken into account, in particular:

(a) the state of the art and technology;

(b) European standards other than those the references of which have been published in the Official Journal of the European Union in accordance with Articles 16 and 17;

(c) international standards;

(d) international agreements;

(e) Commission recommendations or guidelines on product safety assessment;

(f) national standards drawn up in the Member State in which the product is made available;

(g) product safety codes of good practice in force in the sector concerned;

(h) reasonable consumer expectations concerning safety.

Article 7 - Indication of the origin

1. Manufacturers and importers shall ensure that products bear an indication of the country of origin of the product or, where the size or nature of the product does not allow it, that indication is to be provided on the packaging or in a document accompanying the product.

2. For the purpose of determination of the country of origin within the meaning of paragraph 1, 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.

3. Where the country of origin determined in accordance with paragraph 2 is a Member State of the Union, manufacturers and importers may refer to the Union or to a particular Member State.

CHAPTER II - Obligations of economic operators

Article 8 - Obligations of manufacturers

1. When placing their products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the general safety requirement laid down in Article 4.

2. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with the general safety requirement laid down in Article 4.

3. Proportionate to the possible risks of a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of products made available on the market, investigate complaints and keep a register of complaints, non-conforming products and product recalls, and shall keep distributors informed of any such monitoring.

4. Proportionate to the possible risks of a product, manufacturers shall draw up a technical documentation.The technical documentation shall contain, as appropriate:

(a) a general description of the product and its essential properties relevant for assessing the product's safety;

(b) an analysis of the possible risks related to the product and the solutions adopted to eliminate or mitigate such risks, including the outcome of any tests conducted by the manufacturer or by another party on his behalf;

(c) where applicable, a list of the European standards referred to in point (b) of Article 5 or health and safety requirements laid down in the law of the Member State where the product is made available on the market referred to in point (c) of Article 5, or other aspects referred to in Article 6(2), applied to meet the general safety requirement laid down in Article 4.

Where any of the European standards, health and safety requirements or other aspects referred to in point (c) of the first subparagraph have been only partly applied, the parts which have been applied shall be identified.

5. Manufacturers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon request.

6. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing the identification of the product which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.

7. Manufacturers shall 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. The address must indicate a single point at which the manufacturer can be contacted.

8. Manufacturers shall ensure that their product is accompanied by instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available, except where the product can be used safely and as intended by the manufacturer without such instructions and safety information.

Member States shall inform the Commission about any provisions adopted by them determining the required language(s).

9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken.

Article 9 - Authorised representatives

1. A manufacturer may, by a written mandate, appoint an authorised representative.

The obligations laid down in Article 8(1) and (4) shall not form part of the authorised representative's mandate.

2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a) further to a request from a market surveillance authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product;

(b) cooperate with the market surveillance authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.

Article 10 - Obligations of importers

1. Before placing a product on the market importers shall ensure that the product is compliant with the general safety requirement laid down in Article 4 and that the manufacturer has complied with the requirements set out in Article 8(4), (6) and (7).

2. Where an importer considers or has reason to believe that a product is not in conformity with this Regulation, he shall not place the product on the market until it has been brought into conformity. Furthermore, where the product is not safe, the importer shall inform the manufacturer and the market surveillance authorities of the Member State in which he is established to that effect.

3. Importers shall 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. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.

4. Importers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available, except where the product can be used safely and as intended by the manufacturer without such instructions and safety information.

Member States shall inform the Commission about any provisions adopted by them determining the required language(s).

5. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety requirement laid down in Article 4 and its conformity with Article 8(6).

6. Proportionate to the possible risks presented by a product, importers shall, to protect the health and safety of persons, carry out sample testing of marketed products, investigate complaints, and keep a register of complaints, of non-conforming products and of product recalls, and shall keep the manufacturer and distributors informed of such monitoring.

7. Importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, importers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken.

8. Importers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon request.

Article 11 - Obligations of distributors

1. When making a product available on the market, a distributor shall act with due care in relation to the requirements of this Regulation.

2. Before making a product available on the market distributors shall verify that the manufacturer and the importer have complied with the requirements set out in Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable.

3. Where a distributor considers or has a reason to believe that a product is not in conformity with this Regulation, he shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product is not safe, the distributor shall inform the manufacturer or the importer, as applicable, to that effect as well as the market surveillance authority of the Member State in which the distributor is established.

4. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety requirement laid down in Article 4 and its conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable.

5. Distributors who consider or have reason to believe that a product which they have made available on the market is not safe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable, shall make sure that the corrective action necessary to bring that product into conformity is taken, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, distributors shall immediately inform the manufacturer or importer, as applicable as well as market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken.

Article 12 - Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Article 8, where he places a product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the requirements of this Regulation may be affected.

Article 13 - Exemption from certain obligations of manufacturers, importers and distributors

1. Obligation to inform the market surveillance authorities in accordance with Article 8(9), Article 10(2) and (7) and Article 11(3) and (5) shall not apply where the following conditions are fulfilled:

(a) only a limited number of well-identified products are not safe;

(b) the manufacturer, importer or distributor can demonstrate that the risk has been fully controlled and cannot any more endanger the health and safety of persons;

(c) the cause of the risk of the product is such that knowledge of it does not represent useful information for the authorities or the public.

2. The Commission may by means of implementing acts determine the situations which meet the conditions of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 19(3).

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 determining the products, categories or groups of products for which, due to their low level of risk, the information referred to in Article 8(7) and Article 10(3) does not need to be indicated on the product itself.

Article 14 - Identification of economic operators

1. Economic operators shall, on request, identify the following to the market surveillance authorities:

(a) any economic operator who has supplied them with the product;

(b) any economic operator to whom they have supplied the product.

2. Economic operators shall be able to present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the product and for a period of 10 years after they have supplied the product.

Article 15 - Traceability of products

1. For certain products, categories or groups of products which, due to their specific characteristics or specific conditions of distribution or usage, susceptible to bear a serious risk to health and safety of persons, the Commission may require economic operators who place and make available those products on the market to establish or adhere to a system of traceability.

2. The system of traceability 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 the product, its packaging or accompanying documents enabling access to that data.

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 20:

(a) determining the products, categories or groups of products susceptible to bear a serious risk to health and safety of persons as referred to in paragraph 1;

(b) specifying the data which economic operators shall collect and store by means of the traceability system referred to in paragraph 2.

4. The Commission may by means of implementing acts determine the type of data carrier and its placement as referred to in paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 19(3).

5. When adopting the measures referred to in paragraphs 3 and 4, the Commission shall take into account the following:

(a) the cost-effectiveness of the measures, including their impact on businesses in particular small and medium-sized enterprises;

(b) the compatibility with traceability systems available at international level.

CHAPTER III - European standards providing presumption of conformity

Article 16 - Standardisation requests to European standardisation organisations

1. The Commission may request one or several European standardisation organisations to draft or identify a European standard, which aims at ensuring that products that conform to such standard or parts thereof comply with the general safety requirement laid down in Article 4. The Commission shall determine the requirements as to the content to be met by the requested European standard and a deadline for its adoption.

The Commission shall adopt the request referred to in the first subparagraph by an implementing decision. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 19(3).

2. The relevant European standardisation organisation shall indicate, within one month following receipt of the request referred to in paragraph 1, if it accepts it.

3. Where a request for funding is made, the Commission shall inform the relevant European standardisation organisations, within two months following the receipt of the acceptance referred to in paragraph 2, about the award of a grant for drafting a European standard.

4. The European standardisation organisations shall inform the Commission about the activities undertaken for the development of the European standard referred to in paragraph 1. The Commission together with the European standardisation organisations shall assess the compliance of the European standards drafted or identified by the European standardisation organisations with its initial request.

5. Where the European standard satisfies the requirements it aims to cover and the general safety requirement laid down in Article 4, the Commission shall publish a reference to such European standard without delay in the Official Journal of the European Union.

Article 17 - Formal objections to European standards

1. When a Member State or the European Parliament considers that a European standard referred to in Article 16 does not entirely satisfy the requirements it aims to cover and the general safety requirement laid down in Article 4, it shall inform the Commission thereof with a detailed explanation and the Commission shall decide:

(a) to publish, not to publish or to publish with restriction the references to the European standard concerned in the Official Journal of the European Union;

(b) to maintain, to maintain with restriction or to withdraw the references to the European standard concerned in or from the Official Journal of the European Union.

2. The Commission shall publish information on its website on the European standards that have been subject to a decision referred to in paragraph 1.

3. The Commission shall inform the European standardisation organisation concerned of the decision referred to in paragraph 1 and, if necessary, request the revision of the European standard concerned.

4. The decision referred to in point (a) of paragraph 1 of this Article shall be adopted in accordance with the advisory procedure referred to in Article 19(2).

5. The decision referred to in point (b) of paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 19(3).

CHAPTER IV - Final provisions

Article 18 - Penalties

1. The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by [insert date - 3 months prior to the date of application of this Regulation] and shall notify it without delay of any subsequent amendment affecting them.

2. The penalties referred to in paragraph 1 shall have regard to the size of the undertakings and in particular to the situation of small and medium-sized enterprises. The penalties may be increased if the relevant economic operator has previously committed a similar infringement and may include criminal sanctions for serious infringements.

Article 19 - Committee procedure

1. The Commission shall be assisted by a Committee. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

However, for the purposes of Articles 16 and 17 of this Regulation the Commission shall be assisted by the Committee established by Regulation (EU) No 1025/2012. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

4. Where the opinion of the Committee referred to in the second subparagraph of paragraph 1 is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so request.

Article 20 - Exercise of the delegation

1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Articles 13(3) and 15(3) shall be conferred on the Commission for an indeterminate period of time from [insert date - the date of entry into force of this Regulation].

3. The delegation of power referred to in Articles 13(3) and 15(3) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5. A delegated act adopted pursuant to Articles 13(3) and 15(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period may be extended by two months at the initiative of the European Parliament or of the Council.

Article 21 - Evaluation

No later than [five] years after the date of application, the Commission shall assess the application of this Regulation and transmit an evaluation report to the European Parliament and the Council. This report shall assess if this Regulation achieved its objectives, in particular with regard to enhancing the protection of consumers against unsafe products, taking into account its impact on business and in particular on small and medium-sized enterprises.

Article 22 - Repeal

1. Directive 2001/95/EC is repealed with effect from [insert date - day of application of this Regulation].

2. Directive 87/357/EEC is repealed with effect from [insert date - day of application of this Regulation].

3. References to Directive 2001/95/EC and Directive 87/357/EEC shall be construed as references to this Regulation and shall be read in accordance with the correlation table in the Annex.

Article 23 - Transitional provisions

1. Member States shall not impede the making available on the market of products covered by Directive 2001/95/EC which are in conformity with that Directive and which were placed on the market before [insert date - day of application of this Regulation].

2. European standards the reference of which is published in the Official Journal of the European Union in accordance with Directive 2001/95/EC shall be deemed to be European standards referred to in point (b) of Article 5 of this Regulation.

3. Mandates given by the Commission to a European standardisation organisation in accordance with Directive 2001/95/EC shall be deemed standardisation requests referred to in Article 15(1) of this Regulation.

Article 24

1. This Regulation shall enter into force on [insert date - the same day as entry into force of Regulation (EU) No […/…][on market surveillance of products].

2. It shall apply from [insert date - the same day as date of application of Regulation (EU) No […/…][on market surveillance of products].

This Regulation shall be binding in its entirety and directly applicable in all Member States.