- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (31/12/2020)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (Text with EEA relevance)
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information enabling a precise identification of the product or batch of products in question;
a full description of the risk that the products in question present;
all available information relevant for tracing the product;
a description of the action undertaken to prevent risks to consumers.
Pharmaceuticals, which come under Directives 75/319/EEC(1) and 81/851/EEC(2), are excluded from the scope of RAPEX.
information enabling the product to be identified;
a description of the risk involved, including a summary of the results of any tests/analyses and of their conclusions which are relevant to assessing the level of risk;
the nature and the duration of the measures or action taken or decided on, if applicable;
information on supply chains and distribution of the product, in particular on destination countries.
Such information must be transmitted using the special standard notification form and by the means stipulated in the guidelines referred to in point 8.
When the measure notified pursuant to Article 11 or Article 12 seeks to limit the marketing or use of a chemical substance or preparation, the Member States shall provide as soon as possible either a summary or the references of the relevant data relating to the substance or preparation considered and to known and available substitutes, where such information is available. They will also communicate the anticipated effects of the measure on consumer health and safety together with the assessment of the risk carried out in accordance with the general principles for the risk evaluation of chemical substances as referred to in Article 10(4) of Regulation (EEC) No 793/93(3) in the case of an existing substance or in Article 3(2) of Directive 67/548/EEC(4) in the case of a new substance. The guidelines referred to in point 8 shall define the details and procedures for the information requested in that respect.
whether the product has been marketed in their territory;
what measures concerning the product in question they may be adopting in the light of their own circumstances, stating the reasons, including any differing assessment of risk or any other special circumstance justifying their decision, in particular lack of action or of follow-up;
any relevant supplementary information they have obtained on the risk involved, including the results of any tests or analyses carried out.
The guidelines referred to in point 8 shall provide precise criteria for notifying measures limited to national territory and shall specify how to deal with notifications concerning risks which are considered by the Member State not to go beyond its territory.
(REFERRED TO IN THE FIRST SUBPARAGRAPHE OF ARTICLE 22)
Directive | Period for transposition | Period for bringing into application |
---|---|---|
Directive 92/59/EEC | 29 June 1994 | 29 June 1994 |
(REFERRED TO IN THE SECOND SUBPARAGRAPH OF ARTICLE 22)
This Directive | Directive 92/59/EEC |
---|---|
Article 1 | Article 1 |
Article 2 | Article 2 |
Article 3 | Article 4 |
Article 4 | — |
Article 5 | Article 3 |
Article 6 | Article 5 |
Article 7 | Article 5(2) |
Article 8 | Article 6 |
Article 9 | — |
Article 10 | — |
Article 11 | Article 7 |
Article 12 | Article 8 |
Article 13 | Article 9 |
Articles 14 and 15 | Article 10 |
Article 16 | Article 12 |
Article 17 | Article 13 |
Article 18 | Article 14 |
Article 19 | Article 15 |
Article 20 | — |
Article 21 | Article 17 |
Article 22 | Article 18 |
Article 23 | Article 19 |
Annex I | — |
Annex II | Annex |
Annex III | — |
Annex IV | — |
OJ L 147, 9.6.1975, p. 13. Directive as last amended by Commission Directive 2000/38/EC (OJ L 139, 10.6.2000, p. 28).
OJ L 317, 6.11.1981, p. 1. Directive as last amended by Commission Directive 2000/37/EC (OJ L 139, 10.6.2000, p. 25).
OJ 196, 16.8.1967, p. 1/67. Directive as last amended by Commission Directive 2000/33/EC (OJ L 136, 8.6.2000, p. 90).
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