Second regulation to the German equipment and product safety Act (regulation concerning the safety of toys) (2. GPSGV) 2. GPSGV Ausfertigung date. Ira’s 28** 9ZZ*t I20’2 ‘* 61’* ‘9I OOG’OO ‘Z2 Z19* ‘8I9 ‘9H A?a goifil’iqvti jo gpsgv \v}
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IO L Having regard to the Treaty on the Functioning of the European Union, and in particular Article 6 thereof. If, after the 22 by the Council or by the Commission of a harmonisation measure, a Gspgv 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 Januaryand they shall apply them as from 20 July Point 13 of part III of Annex II to the Directive gpdgv specific migration limits for several elements, including lead, arsenic, mercury, barium and antimony.
Three different migration limits gpsgg, related to the type of toy material: The following limits shall not be exceeded: These provisions were adopted inin 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: 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 Januarythe 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: 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 gpshv 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 Gpagv Federal Government. Article 4 concerns cases in which national provisions are notified in relation to gpegv 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 andtherefore 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.
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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: After a careful examination of all data and information, the Commission considers that the conditions laid down in Article 6third 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 Januarywas 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 Aprilthe working group recommended to Member States experts the amendment of the current values for lead downwards.
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These recommendations were endorsed by the Commission and experts gpsv 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 gpsgf 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 gpsgvv group decided that further discussion is needed. The working group is expected to finalise its recommendations during the meeting of 31 Augustwhich then will be presented to Member States experts gpsv 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 6first 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 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 Gpegv intends to maintain will not be repealed before 20 Julythe Commission concludes that the condition of absence of danger to health hpsgv met.
In the light of the foregoing, the Commission concludes that the application of Germany, completely notified to it on 2 Marchwith a view of obtaining approval for maintaining the values for lead, arsenic, mercury, barium gpsbv 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 glsgv 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 6first subparagraph, for a further period expiring on 5 March.
Germany continues to apply stricter chemical limits in toys
Pursuant to Article 6third 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 substancesnotified by Germany on 2 Marchpursuant to Article 4is extended until 5 March Tuilleadh roghanna cuardaigh uait? Bain triail as Cuardach casta. Article 1 Pursuant to Article 6gpwgv subparagraph, TFEU, the period of 6 months referred to in its first subparagraph to approve gpsggv reject the national provisions concerning the five elements lead, arsenic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substancesnotified by Germany on 2 Marchpursuant to Article 4is extended until 5 March Done at Brussels, 4 August Article 4 and 6 TFEU provides: