BETA

17 Amendments of Sirpa PIETIKÄINEN related to 2013/0048(COD)

Sirpa PIETIKÄINEN

Proposal for a regulation
Recital 15 a (new)

(15a) Consumers can play an active and important role in contributing to market surveillance, as they are usually in direct contact with products presenting a risk, including products that are not compliant with applicable Union legislation. In that context Member States should raise awareness of the consumers with regard to their rights to submit complaints on issues relating to product safety and market surveillance activities and ensure that the reporting procedure is easily accessible, relatively simple and efficient. The Commission should further explore the opportunities of making the submission of such complaints harmonized throughout the Union, for example through creation of a central database where the complaints filed by the consumers could be stored as well as examine possibilities of making those complaints public, subject to the right of review and reply by the economic operators involved.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Recital 23

(23) There should be effective, speedy and accurate exchange of information among the Member States and between the Member States and the Commission. It is therefore necessary to provide for effective tools for such exchange. The Union rapid information system (RAPEX) has proved its effectiveness and efficiency. RAPEX enables measures to be taken across the Union in relation to products that present a risk beyond the territory of a single Member State. To avoid unnecessary duplication, this system should be used for all alert notifications required by this Regulation relating to products presenting a risk. RAPEX should also include notifications related to Food Contact Materials, moved there from the RASFF platform.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Recital 30

(30) This Regulation should strike a balance between transparency through the release of the maximum possible amount of information to the public and maintaining confidentiality, for example for reasons of ~~personal data protection,~~ commercial secrecy or the protection of investigations, , in accordance with rules on confidentiality pursuant to applicable national law or, as regards the Commission, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. Moreover, this Regulation should respect data protection principles, such as confidential handling of personal data, requirement to process data fairly and lawfully and for specific purpose, while ensuring their quality and allowing the individuals concerned to exercise their rights. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data apply in the context of this Regulation.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1

1. Market surveillance authorities shall organise their activities in such a way that maximum effectiveness can be achieved. They shall perform appropriate checks on the characteristics of products on an adequate scale and with adequate frequency, by means of a documentary check and, where necessary, a physical and laboratory check on the basis of an adequate sample. Where appropriate, along with these traditional market sampling mechanisms, the market surveillance authorities shall move to pro- active auditing of supply chain processes at entities involved in the manufacturing, importing, trading, branding and retailing of consumer products. They shall record these checks in the information and communication system for market surveillance referred to in Article 21.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1

2. ~~Where appropriate, m~~Market surveillance authorities shall without delay alert users in their territories ~~within an adequate timeframe~~ of products that those authorities have identified as presenting a risk. Where available, this information shall also include data on manufacturer, retail channel, pricing, and period of sales.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 8 – paragraph 1

1. On request, economic operators and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities, in a language which can be easily understood by them.deleted

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 8 b (new)

Article 8b Obligations of manufacturers 1. When placing their products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with relevant Union legislation. 2. Proportionate to the possible risks of a product, manufacturers shall have in place adequate quality management systems to ensure the compliance and safety of their products. They shall carry out sample testing of products made available on the market, investigate complaints and keep a register of complaints, nonconforming products and product recalls, and shall keep distributors informed of any such monitoring. 3. Manufacturers shall draw up the required technical documentation in accordance with the relevant Union harmonisation legislation. 4. 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 reasoned request. 5. 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, 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. 6. 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. 7. Manufacturers who consider or have reason to believe that a product which they have placed on the market presents a risk, including non-compliance with the relevant Union harmonisation legislation, shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a serious risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk and of any corrective measure taken.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 8 d (new)

Article 8d Authorised representatives 1. A manufacturer established outside the Union shall appoint an authorised representative established within the Union for the purposes of market surveillance 2. For the purpose of market surveillance, the 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 reasoned 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.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 8 f (new)

Article 8f Obligations of importers 1. Before placing a product on the market importers shall ensure that the product is compliant with relevant Union legislation. 2. Where an importer considers or has reason to believe that a product presents a risk, including non-compliance with the relevant Union harmonisation legislation, he shall not place the product on the market until it has been brought into conformity. Furthermore, where the product presents a serious risk, 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. Proportionate to the possible risks presented by a product, importers shall have in place adequate quality management systems to ensure the compliance and safety of their imported products. They shall 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. 5. Importers who consider or have reason to believe that a product which they have placed on the market presents a risk, including non-compliance with the relevant Union harmonisation legislation, shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a serious risk, importers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk and of any corrective measure taken. 6. 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 reasoned request.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 8 h (new)

Article 8h Obligations of distributors 1. Where a distributor considers or has a reason to believe that a product presents a risk, including non-compliance with the relevant Union harmonisation legislation, he shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product presents a serious risk, 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. 2. Distributors who consider or have reason to believe that a product which they have placed on the market presents a risk, including non-compliance with the relevant Union harmonisation legislation 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 presents a serious risk, 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 and of any corrective action taken. 3. Following a request of the technical documentation to the distributor, he shall take steps to either obtain the documentation himself and hand it to the authority or arrange that the documentation is sent directly by the manufacturer to the authority. In the latter case the distributor remains responsible and liable to sanctions in the event the documentation does not reach the authority. The distributor has the possibility, when having received a reasoned request, to contact the importer, manufacturer or authorised representative in order to obtain the documentation or to arrange that it is sent directly to the authority. The obligation for distributors to provide the technical documentation to an authority upon reasoned request does not include an obligation to keep it.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 1 – point a a (new)

(aa) the product or any presentation of the product bears without authorisation a trade mark that is identical or similar to a registered trade mark for this product, thereby not allowing to guarantee its authenticity or origin;

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 13 – paragraph 4 d (new)

4d. In cases where Member State risk assessment practices differ and result in divergent interpretations as to the necessity of measures in respect of similar products, the Commission shall provide guidance on appropriate risk assessment practices. The Commission shall be assisted by the scientific committees established under Commission Decision 2004/210/EC and take into account all available scientific and technical evidence relating to the risks under consideration.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 14 – paragraph 3 – subparagraph 2 – point b b (new)

(bb) the product or any presentation of the product bears without authorisation a trade mark that is identical or similar to a registered trade mark for this product, thereby not allowing to guarantee its authenticity or origin;

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 19 – paragraph 4

4. Participation in RAPEX shall be open to applicant countries, third countries or international organisations within the framework of and in accordance with agreements between the Union and those countries or organisations. Any such agreements shall be based on reciprocity and include provisions on confidentiality corresponding to those applicable in the Union as well as special provisions on personal data protection, as required by Article 25 of Directive 95/46/EC and Article 9 of Regulation (EC) No 45/2001.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1 – point g a (new)

(ga) Whether the product is known to be counterfeit

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 22 – paragraph 1

The Commission and Member States may exchange confidential information, including information exchanged through RAPEX, with regulatory authorities of third countries or international organisations with which the Commission and the Member State or group of Member States have concluded bilateral or multilateral confidentiality arrangements based on reciprocity. Any such arrangements shall include provisions on confidentiality corresponding to those applicable in the Union as well as special provisions on personal data protection, as required by Article 25 of Directive 95/46/EC and Article 9 of Regulation (EC) No 45/2001.

2013/09/11
Committee: IMCO

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 31 – paragraph 1 a (new)

The penalties provided for must be effective, proportionate and dissuasive. Where the infringement has been committed intentionally, these penalties shall include, inter alia, administrative penalties for the relevant economic operator of up to 10 % of its total annual turnover in the preceding business year;

2013/09/11
Committee: IMCO