DECISIONS
COMMISSION DECISION
of 4 August 2011
extending the period referred to in Article 114(6) of the Treaty on the Functioning of the European Union in relation to national provisions maintaining the limit values for lead, barium, arnic, antimony, mercury and nitrosamines and nitrosatable substances in toys notified by Germany
pursuant to Article 114(4)
(notified under document C(2011) 5355)
(Only the German text is authentic)
(Text with EEA relevance)
(2011/510/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114(6) thereof,
Whereas:
FACTS
(1) On
20 January 2011, the German Federal Government requested the Commission, pursuant to Article 114(4) of the Treaty on the Functioning of the European Union (TFEU), the permission to retain the existing provisions provided in German law for the five elements: lead, arnic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances relead from toy material, beyond the date of entry into force of Annex II, Part III of Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys ( 1 ).
Article 114(4) and (6) TFEU
(2) Article
114(4) and (6) TFEU provides: ‘4. 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 the provisions as well as the grounds for main taining them.
(…)
6. The Commission shall, within 6 months of the notification, approve or reject the national provisions involved after having verified whether or not they are a means of arbitrary discrimination or a disguid restriction to trade between Member States and whether or not they shall constitute an obstacle to the functioning of the internal market.
In the abnce of a Decision by the Commission within this period the national provisions referred to in paragraphs 4 (…) shall be deemed to have been approved.
When justified by the complexity of the matter and in the abnce of danger for human health, the Commission may notify the Member State concerned that the period referred to in this paragraph may be extended for a further period of up to 6 months.’
Directive 2009/48/EC
(3) Directive
2009/48/EC (hereinafter ‘the Directive’) lays down rules on the safety of toys and on their free
movement in the European Union. According to Article 54, Member States shall bring into force national provisions complying with this Directive by 20 January 2011, and they shall apply them as from 20 July 2011. Part III of Annex II to the Directive will be applicable as from 20 July 2013.
(4)
The Directive contains, in Annex II, part III, point 8, specific values for nitrosamines and nitrosatable substances. The substances shall be prohibited for u in toys intended for u by children under 36 months or in other toys intended to be placed in the mouth if the migration of the substances is equal to or higher than 0,05 mg/kg for nitrosamines and 1 mg/kg for nitro satable substances. Point 13 of part III of Annex II to
( 1 ) OJ L 170, 30.6.2009, p. 1.
the Directive contains specific migration limits for veral
elements, including lead, arnic, 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. The following limits shall not be exceeded: 13,5, 3,4 and 160 mg/kg for lead, 3,8, 0,9 and 47 mg/kg for arnic, 7,5, 1,9 and 94 mg/kg for mercury, 4 500, 1 125 and 56 000 mg/kg for barium, and 45, 11,3 and 560 mg/kg for antimony.
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The German national provisions
(5) The
German Consumer Goods Ordinance (Bedarfsgegen ständeverordnung ) ts requirements for nitrosamines and nitrosatable substances. The provisions were adopted in 2008, in the context of the abnce of specific EU provisions on nitrosamines and nitrosatable substances in toys. The Consumer Goods Ordinance (Bedarfsgegen ständeverordnung ) requires that for nitrosamines and nitro satable substances in toys made of natural or synthetic rubber designed for children under 36 months and intended or likely to be placed in the mouth, the amount relead as a result of migration must be so small as not to be laboratory detectable. The abovemen tioned Ordinance currently requires the migration of nitrosamines and nitrosatable substances to be below 0,01 mg/kg
for nitrosamines and below 0,1 mg/kg for nitrosatable substances. The detailed provisions on nitro samines and nitrosatable substances are laid down in Annex 4, point 1.b, and Annex 10, point 6, of the Consumer Goods Ordinance (Bedarfsgegenständever ordnung ), published on 23 December 1997, and most recently amended by the Ordinance of 6 March 2007.
(6) The Second Equipment and Product Safety Act
Ordinance (Verordnung über die Sicherheit von Spielzeug –
2. GPSGV ) concerns in particular the following elements: lead, arnic, mercury, barium and antimony. The limit values for the abovementioned elements contained in the Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug – 2. GPSGV ) are tho laid down in Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the
Member States concerning the safety of toys ( 1 ). The
limits have been applicable in the EU since 1990. The maximum daily bioavailability is 0,7 μg for lead, 0,1 μg for arnic, 0,5 μg for mercury, 25 μg for barium, and 0,2 μg for antimony. The detailed p
rovisions on the abovementioned elements are laid down in § 2 of the Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug – 2. GPSGV ), most recently amended by the Ordinance of 6 March 2007.
PROCEDURE
(7)
At the time of adoption of the Directive (May 2009) Germany voted against its adoption for reasons including its view that the level of protection as regards the chemical requirements is inadequate.
(8)
With a first letter of its Federal Ministry of Economic Affairs and Technology, received on 20 January 2011, the German Federal Government requested the Commission, pursuant to Article 114(4) TFEU, the permission to retain the existing provisions provided in German law for the five elements: lead, arnic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances relead 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 nt by the German Federal Government with letter fr
om the Office of its Permanent Reprentative, dated 2 March 2011. The detailed justification contained veral annexes including scientific studies on the health asssment of the above mentioned substances from the Bundesinstitut für Risi kobewertung (hereinafter ‘BfR’), dating January 2011.
(9) The
Commission confirmed receipt of the request with letters dated 24 February and 14 March 2011 and t the deadline for her reaction to 5 September 2011 in accordance with Article 114(6) TFEU.
(10) By
letter of 24 June 2011 the Commission informed the other Member States of the notification received from the German Federal Government. The Commission also published a notice regarding the notification in the
Official Journal of the European Union ( 2 ) in order to
inform other interested parties of the national provisions the German Federal Government intends to maintain as well as the grounds invoked to that effect.
ASSESSMENT
Admissibility
(11) Article
114(4) concerns cas in which national provisions are notified in relation to an EU harmon
isation 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. The national provisions were notified in relation to Directive 2009/48/EC, a harmonisation measure adopted on the basis of Article 95 of the former EC Treaty. They were adopted and entered into force in 1990 and 2008, therefore before the adoption of that Directive.
Furthermore, Article 114(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.
( 1 ) OJ L 187, 16.7.1988, p. 1.
( 2 ) OJ C 159, 28.5.2011, p. 23.
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, arnic, mercury,
barium and antimony, as well as for nitrosamines and
nitrosatable substances, is admissible.
Recour to Article 114(6), third subparagraph TFEU
(12) After a careful examination of all data and information,
the Commission considers that the conditions laid down
in Article 114(6), third subparagraph, are met in order
for it to have recour to the possibility of extending the
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6-month period within which it has to approve or reject
the national provisions notified by Germany.
Justification bad on the complexity of the matter
(13) The German Federal Government provided veral
annexes containing detailed justification and scientific
information in support of the notified national
measures. In particular, health asssment from the BfR
on lead, antimony, barium, arnic and mercury, as well
as on nitrosamines and nitrosatable substances, dating
from January 2011, was provided.丑小鸭告诉我们一个什么道理
(14) 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. It is necessary, in order to
proceed to a Commission decision pursuant to
Article 114(6) TFEU, to verify if the information
provided by Germany was already assd and
considered during the Directive’s revision process, or if
it is to be considered as new scientific information.
(15) The directive forees, in Article 46, the possibility to
amend certain chemical-related provisions in order to
ensure alignment on technical and scientific devel
opments. The five elements concerned by Germany’s
request (lead, arnic, barium, mercury and antimony)
can therefore be amended and aligned on the latest
scientific information.
(16) The Commission t up, in 2010, a working group on
chemical substances in toys (hereinafter ‘the working
group’), at the request of Member States. 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.
(17) The Commission will ek 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 ud as a basis for
amending the chemical provisions of the Directive by
tting out stringent requirements. The next meeting of
the working group is foreen on 31 August 2011.
(18) Furthermore, on 5 April 2011, the working group
recommended to Member States experts the amendment of the current values for lead downwards.
The recommendations were endord by the
Commission and experts from Member States. The
Commission started the preparatory work for this
amendment and the preliminary impact asssment
report will be prented for discussion during the next
meeting with Member States experts in October 2011. A
formal proposal is planned for adoption in the first half
of 2012.
(19) The working group discusd the current limit values for
barium, and stated that no new scientific evidence was
available; however different asssments by scientific
organisations were taken. The working group decided
that further discussion is needed. The working group is
expected to finali its recommendations during the
meeting of 31 August 2011, which then will be
prented to Member States experts in October 2011.
(20) The Scientific Committee for Consumer Safety (SCCS) is
批评自我批评currently evaluating the riousness of the risk pod by
the prence of nitrosamines and nitrosatable substances
in balloons and cosmetic products. This opinion,
expected for September 2011, will bring new light on
children’s exposure to nitrosamines and nitrosatables
substances and on the risk related to this exposure.
(21) The Commission Decision pursuant to Article 114(6),
first subparagraph, should therefore await the outcome
of the ongoing discussions and evaluations, in order to
carefully asss all relevant current or future evidence and
draw conquences as regards to the national measures.板式换热器原理
满足近义词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
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period expiring on 5 March 2012.
Abnce of danger to human health
(22) As indicated in Article 55 of the Directive, point 8 and
13 of part III, Annex II will be applicable from 20 July
2013. Until 20 July 2013, the current provisions related
to lead, antimony, barium, arnic and mercury laid
down in Directive 88/378/EEC and in the Second
Equipment and Product Safety Act Ordinance (Verordnung
über die Sicherheit von Spielzeug – 2. GPSGV) will apply. As
there are no applicable EU provisions on nitrosamines
and nitrosatable substances relead from toys, Annex 4,
point 1.b, and Annex 10, point 6, of the Consumer
Goods Ordinance (Bedarfsgegenständeverordnung) remains
as well applicable until 20 July 2013.
(23)Therefore, as the national provisions the German Federal
Government intends to maintain will not be repealed
before 20 July 2013, the Commission concludes that
the condition of abnce of danger to health is met.
CONCLUSION
(24)In the light of the foregoing, the Commission concludes
that the application of Germany, completely notified to it
on 2 March 2011, with a view of obtaining approval for
maintaining the values for lead, arnic, mercury, barium
and antimony, as well as for nitrosamines and nitro
satable substances, for u in toys intended for u by
children under 36 months or in other toys intended to
be placed in the mouth, is admissible.
(25)However, in view of the complexity of the matter and of
the abnce of evidence highlighting a danger for human
health, the Commission considers it justified to extend
the period referred to in Article 114(6), first
subparagraph, for a further period expiring on 5 March
自然的反义词
2012,HAS ADOPTED THIS DECISION:
Article 1
Pursuant to Article 114(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, arnic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances), notified by Germany on 2 March 2011, pursuant to Article 114(4), is extended until 5 March 2012.
Article 2
This Decision is addresd to the Federal Republic of Germany. Done at Brusls, 4 August 2011.
For the Commission
Antonio TAJANI
Vice-President
