2 GPSGV PDF

Hence, the Commission considers that it is justified to extend the 6-month period within which it has to approve or reject the national provisions for a further period expiring on 5 March IO L A complete justification of the request has been sent by the German Federal Government with letter from the Office of its Permanent Representative, dated 2 March Germany contested this decision by bringing an action against the EC in May to ensure that the stricter German limit values would be allowed to remain in place. The directive foresees, in Article 46, the possibility to amend certain chemical-related provisions in order to ensure alignment on technical and scientific developments. The application submitted by Germany contains an explanation of the reasons relating to the protection of the human health which, in the opinion of Germany, justify the maintenance of its national provisions. They were adopted and entered into force in andtherefore before the adoption of that Directive.

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OJ L , Having regard to the Treaty on the Functioning of the European Union, and in particular Article 6 thereof,. If, after the adoption by the Council or by the Commission of a harmonisation measure, a Member State deems it necessary to maintain national provisions on grounds of major needs referred to in Article 36, or relating to the protection of the environment or the working environment, it shall notify the Commission of these provisions as well as the grounds for maintaining them.

In the absence of a Decision by the Commission within this period the national provisions referred to in paragraphs 4 … shall be deemed to have been approved. According to Article 54, Member States shall bring into force national provisions complying with this Directive by 20 January , and they shall apply them as from 20 July Point 13 of part III of Annex II to the Directive contains specific migration limits for several elements, including lead, arsenic, mercury, barium and antimony.

Three different migration limits exist, related to the type of toy material: dry, brittle, power-like or pliable toy material, liquid or sticky toy material and scraped-off toy material. These provisions were adopted in , in the context of the absence of specific EU provisions on nitrosamines and nitrosatable substances in toys. The detailed provisions on nitrosamines and nitrosatable substances are laid down in Annex 4, point 1. GPSGV concerns in particular the following elements: lead, arsenic, mercury, barium and antimony.

These limits have been applicable in the EU since At the time of adoption of the Directive May Germany voted against its adoption for reasons including its view that the level of protection as regards the chemical requirements is inadequate.

With a first letter of its Federal Ministry of Economic Affairs and Technology, received on 20 January , the German Federal Government requested the Commission, pursuant to Article 4 TFEU, the permission to retain the existing provisions provided in German law for the five elements: lead, arsenic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances released from toy material, beyond the date of entry into force of Annex II, Part III of the Directive.

A complete justification of the request has been sent by the German Federal Government with letter from the Office of its Permanent Representative, dated 2 March The Commission confirmed receipt of the request with letters dated 24 February and 14 March and set the deadline for her reaction to 5 September in accordance with Article 6 TFEU.

By letter of 24 June the Commission informed the other Member States of the notification received from the German Federal Government. Article 4 concerns cases in which national provisions are notified in relation to an EU harmonisation measure, where the former were adopted and entered into force before the adoption of the latter and where the maintenance of the national provisions would be incompatible with the EU harmonisation measure.

They were adopted and entered into force in and , therefore before the adoption of that Directive. Furthermore, Article 4 requires that the notification of the national provisions be accompanied by a description of the grounds relating to one or more of the major needs referred to in Article 36 or to the protection of the environment or the working environment. The application submitted by Germany contains an explanation of the reasons relating to the protection of the human health which, in the opinion of Germany, justify the maintenance of its national provisions.

In the light of the foregoing, the Commission considers that the application submitted by Germany with a view to obtaining authorisation to maintain its national provisions on the five elements: lead, arsenic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances, is admissible. After a careful examination of all data and information, the Commission considers that the conditions laid down in Article 6 , third subparagraph, are met in order for it to have recourse to the possibility of extending the 6-month period within which it has to approve or reject the national provisions notified by Germany.

The German Federal Government provided several annexes containing detailed justification and scientific information in support of the notified national measures. In particular, health assessment from the BfR on lead, antimony, barium, arsenic and mercury, as well as on nitrosamines and nitrosatable substances, dating from January , was provided.

The information received from the BfR contains detailed and complex toxicological data on the abovementioned substances, as well as extended references to scientific reports and literature. The directive foresees, in Article 46, the possibility to amend certain chemical-related provisions in order to ensure alignment on technical and scientific developments.

This working group, made up of chemical experts from the Czech Republic, Denmark, Germany, France, Italy, the Netherlands, Austria, Sweden and Industry and Consumer organisations evaluates new scientific information and gives recommendations to Member States and the Commission on how to proceed with the amendment of certain chemical provisions contained in the Directive. The Commission will seek the opinion of the working group on the detailed justification received from Germany, to determine if it can be considered as new scientific information and therefore used as a basis for amending the chemical provisions of the Directive by setting out stringent requirements.

The next meeting of the working group is foreseen on 31 August Furthermore, on 5 April , the working group recommended to Member States experts the amendment of the current values for lead downwards.

These recommendations were endorsed by the Commission and experts from Member States. The Commission started the preparatory work for this amendment and the preliminary impact assessment report will be presented for discussion during the next meeting with Member States experts in October A formal proposal is planned for adoption in the first half of The working group discussed the current limit values for barium, and stated that no new scientific evidence was available; however different assessments by scientific organisations were taken.

The working group decided that further discussion is needed. The working group is expected to finalise its recommendations during the meeting of 31 August , which then will be presented to Member States experts in October The Scientific Committee for Consumer Safety SCCS is currently evaluating the seriousness of the risk posed by the presence of nitrosamines and nitrosatable substances in balloons and cosmetic products. The Commission Decision pursuant to Article 6 , first subparagraph, should therefore await the outcome of the ongoing discussions and evaluations, in order to carefully assess all relevant current or future evidence and draw consequences as regards to the national measures.

Hence, the Commission considers that it is justified to extend the 6-month period within which it has to approve or reject the national provisions for a further period expiring on 5 March GPSGV will apply.

As there are no applicable EU provisions on nitrosamines and nitrosatable substances released from toys, Annex 4, point 1. Therefore, as the national provisions the German Federal Government intends to maintain will not be repealed before 20 July , the Commission concludes that the condition of absence of danger to health is met.

In the light of the foregoing, the Commission concludes that the application of Germany, completely notified to it on 2 March , with a view of obtaining approval for maintaining the values for lead, arsenic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances, for use in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth, is admissible.

However, in view of the complexity of the matter and of the absence of evidence highlighting a danger for human health, the Commission considers it justified to extend the period referred to in Article 6 , first subparagraph, for a further period expiring on 5 March ,. Pursuant to Article 6 , third subparagraph, TFEU, the period of 6 months referred to in its first subparagraph to approve or reject the national provisions concerning the five elements lead, arsenic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances , notified by Germany on 2 March , pursuant to Article 4 , is extended until 5 March Skip to main content.

This document is an excerpt from the EUR-Lex website. EU case-law Case-law Digital reports Directory of case-law. Quick search. Need more search options? Use the Advanced search. Help Print this page. Expand all Collapse all. Title and reference. Languages, formats and link to OJ. Official Journal. Multilingual display. Done at Brussels, 4 August

ETHAN BERMAN AT RISKMETRICS GROUP PDF

Second Regulation on the Equipment and Product Safety Act (toys) (2). GPSGV)

No liability is assumed for translation mistakes. The German original as published in the Bundesgesetzblatt is authoritative. The Bundestag has, with the consent of the Bundesrat, resolved to adopt the following Act:. Chapter 3 Surveillance of the Bringing into Circulation of Products.

DIVINA COMMEDIA PASQUINI QUAGLIO PDF

Equipment and Product Safety Act (Geräte- und Produktsicherheitsgesetz, GPSG)

OJ L , Having regard to the Treaty on the Functioning of the European Union, and in particular Article 6 thereof,. If, after the adoption by the Council or by the Commission of a harmonisation measure, a Member State deems it necessary to maintain national provisions on grounds of major needs referred to in Article 36, or relating to the protection of the environment or the working environment, it shall notify the Commission of these provisions as well as the grounds for maintaining them. In the absence of a Decision by the Commission within this period the national provisions referred to in paragraphs 4 … shall be deemed to have been approved. According to Article 54, Member States shall bring into force national provisions complying with this Directive by 20 January , and they shall apply them as from 20 July

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