委员会条例(EU) No 836/2012,就铅含量限制,修订关于化学品注册、评估、授权和限制(REACH) 条例(EC) No 1907/2006的附件XVII (1)
技术法规类型:欧盟Eurlex法规 来源:tbtmap
EURLEX ID:32012R0836
OJ编号:OJ L 252, 19.9.2012, p. 4-6
中文标题:委员会条例(EU) No 836/2012,就铅含量限制,修订关于化学品注册、评估、授权和限制(REACH) 条例(EC) No 1907/2006的附件XVII (1)
原文标题:Commission Regulation (EU) No 836/2012 of 18 September 2012 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead (1)
分类:15.30_健康保护;15.20.30_健康与安全保护
文件类型:二级立法 Regulation|条例
生效日期:2012-10-09
废止日期:2058-12-31
法规全文:查看欧盟官方文件
EN
Official Journal of the European Union
19.9.2012
COMMISSION REGULATION (EU) No 836/2012
of 18 September 2012
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as
regards lead
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
appropriate Union-wide measure to address the identified
risks in terms of the effectiveness in reducing the risks is
the prohibition of the placing on the market and use of
Having regard to the Treaty on the Functioning of the European
lead and its compounds in metallic and non-metallic
Union,
parts of jewellery articles, if the lead concentration is
equal to or greater than 0,05 % by weight of the indi
vidual part, unless it can be demonstrated that the rate of
Having regard to Regulation (EC) No 1907/2006 of the
lead released does not exceed the limit of 0,05 μg/cm
European Parliament and of the Council of 18 December
2 /h
(0,05 μg/g/h).
2006 concerning the Registration, Evaluation, Authorisation
and Restriction of Chemicals (REACH), establishing a
European Chemicals Agency, amending Directive 1999/45/EC
and repealing Council Regulation (EEC) No 793/93 and
(4) In
its
opinion
of
15
September
2011,
the
Committee
for
Commission Regulation (EC) No 1488/94 as well as Council
Socio-Economic Analysis (hereinafter ‘SEAC’) considered
Directive 76/769/EEC and Commission Directives 91/155/EEC,
the prohibition of the placing on the market and use of
93/67/EEC, 93/105/EC and 2000/21/EC ( 1 ), and in particular
lead and its compounds in jewellery articles, if the lead
Article 68(1) thereof,
concentration is equal to or greater than 0,05 % by
weight of any individual part thereof. This measure was
considered as the most appropriate Union-wide measure
Whereas:
to address the identified risks in terms of the propor
tionality of its socioeconomic benefits to its socioe
conomic costs. In view of the current non-availability
(1) In
accordance
with
Regulation
(EC)
No
1907/2006,
if
a
of a migration testing method mimicking mouthing
Member State considers that the manufacture, placing on
conditions, SEAC considered that the restriction should
the market or use of a substance on its own, in a mixture
be based on the content of lead in any individual part of
or in an article poses a risk to human health or the
jewellery articles, and not on the migration rate of lead
environment that is not adequately controlled and
released from such articles. In addition, SEAC recom
needs to be addressed, it shall prepare a dossier after
mended exemptions to be provided for crystal glass,
notifying that intention to the European Chemicals
vitreous enamels, internal components of watch time
Agency (hereinafter ‘the Agency’).
pieces as well as non-synthetic or reconstructed
precious and semiprecious stones.
(2)
On 15 April 2010 France submitted to the Agency a
dossier pursuant to Article 69(4) of Regulation (EC) No
1907/2006, in order to initiate a restriction process in
(5) On
23
September
2011
the
Agency
submitted
to
the
accordance with Articles 69 to 73 of that Regulation. In
Commission the opinions of the RAC and the SEAC.
that dossier, it was demonstrated that due to their
mouthing behaviour, children, especially those under
36 months, can be repeatedly exposed to lead released
from jewellery articles. Such repeated exposure to lead
(6)
Given the lack of information on the release of lead
can result in severe and irreversible neurobehavioural and
under mouthing conditions and due to the lack of
neurodevelopmental effects, to which children are
suitable alternatives for all uses in crystal glass and
particularly sensitive given that their central nervous
vitreous enamels, the latter are being exempted from
system is still under development. The dossier demon
the present measure. Moreover SEAC recommended the
strates that action on a Union-wide basis is necessary,
exemption only for categories 1 and 2 of crystal glass
beyond any measures already in place, in order to avoid
(respectively ‘Full Lead Crystal’ and ‘Lead Crystal’) as
as much as possible the exposure to lead and its
defined in Annex I to Council Directive 69/493/EEC of
compounds in jewellery articles. Accordingly, the
15 December 1969 on the approximation of the laws of
dossier proposes a prohibition of placing on the
the Member States relating to crystal glass ( 2 ). However
market and the use of lead and its compounds in
categories 3 and 4 of crystal glass (‘crystal glass, cryst
jewellery articles if the lead migration rate is greater
allin’) as defined in that Directive should also be
than 0,09 μg/cm 2 /h.
exempted from the restriction, in order to ensure
consistency with the exemption laid down in the
Annex to Directive 2002/95/EC of the European
(3) In
its
opinion
of
10
March
2011,
the
Committee
for
Risk
Parliament and of the Council of 27 January 2003 on
Assessment (hereinafter ‘RAC’) considered that the most
the restriction of the use of certain hazardous substances
( 1 ) OJ L 396, 30.12.2006, p. 1.
( 2 ) OJ L 326, 29.12.1969, p. 36.
EN
19.9.2012 Official
Journal
of
the
European
Union L
252/5
in electrical and electronic equipment ( 1 ), as amended by
(10) The
Commission should carry out a review of the
Commission Decision 2010/571/EU ( 2 ), and as they have
exemption of crystal, vitreous enamels and precious
a lower content of lead compared to categories 1 and 2.
and semi-precious stones in the light of new available
scientific information, including the migration of lead
(7) For
the
same
reasons
applicable
to
crystal
glass
and
from those exempted uses, the availability of suitable
vitreous enamels, non-synthetic or reconstructed
alternatives as well as the development of migration
precious and semiprecious stones in which lead is
test methods.
present as a naturally occurring constituent should be
exempted.
(11) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Committee estab
lished under Article 133 of Regulation (EC) No
(8) Internal
components
of
watch
timepieces
which
are
inaccessible to consumers should be exempted from the
1907/2006,
restriction, as exposure to lead from those components
can be excluded.
HAS ADOPTED THIS REGULATION:
(9)
A restriction on the placing on the market of second-
Article 1
hand and antique jewellery would have a significant
Annex XVII to Regulation (EC) No 1907/2006 is amended in
socioeconomic impact, as such items would lose their
accordance with the Annex to this Regulation.
marketable value in the Union, and would pose
difficulties for enforcement. Therefore, jewellery articles
Article 2
placed on the market for the first time up to 12 months
after the entry into force of the restriction as well as
This Regulation shall enter into force on the twentieth day
imported antique jewellery articles should be exempted
following that of its publication in the Official Journal of the
from the restriction.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 September 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 37, 13.2.2003, p. 19.
( 2 ) OJ L 251, 25.9.2010, p. 28.
L 252/6
EN
Official Journal of the European Union
19.9.2012
ANNEX
In Annex XVII to Regulation (EC) No 1907/2006, the following entry 63 is added:
‘63. Lead
1. Shall not be placed on the market or used in any individual part of
CAS No 7439-92-1
jewellery articles if the concentration of lead (expressed as metal) in
EC No 231-100-4
such a part is equal to or greater than 0,05 % by weight.
and its compounds
2. For the purposes of paragraph 1:
(i) “jewellery articles” shall include jewellery and imitation jewellery
articles and hair accessories, including:
(a) bracelets, necklaces and rings;
(b) piercing jewellery;
(c) wrist watches and wrist-wear;
(d) brooches and cufflinks;
(ii) “any individual part” shall include the materials from which the
jewellery is made, as well as the individual components of the
jewellery articles.
3. Paragraph 1 shall also apply to individual parts when placed on the
market or used for jewellery-making.
4. By way of derogation, paragraph 1 shall not apply to:
(a) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to
Council Directive 69/493/EEC (*);
(b) internal components of watch timepieces inaccessible to consumers;
(c) non-synthetic or reconstructed precious and semiprecious stones (CN
code 7103, as established by Regulation (EEC) No 2658/87), unless
they have been treated with lead or its compounds or mixtures
containing these substances;
(d) enamels, defined as vitrifiable mixtures resulting from the fusion,
vitrification or sintering of minerals melted at a temperature of at
least 500 °C.
5. By way of derogation, paragraph 1 shall not apply to jewellery articles
placed on the market for the first time before 9 October 2013 and
jewellery articles produced before 10 December 1961.
6. By 9 October 2017, the Commission shall re-evaluate this entry in the
light of new scientific information, including the availability of alter
natives and the migration of lead from the articles referred to in
paragraph 1 and, if appropriate, modify this entry accordingly.
(*) OJ L 326, 29.12.1969, p. 36.’
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