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7.12.2013 Official
Journal
of
the
European
Union L
328/69
COMMISSION REGULATION (EU) No 1272/2013
of 6 December 2013
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 polycyclic aromatic hydrocarbons
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
conclusion
regarding
the
risk
to
consumers
was
based on the estimated dermal exposure to PAHs
arising from the use of certain consumer articles, under
Having regard to the Treaty on the Functioning of the European
realistic worst-case conditions of use. That exposure was
Union,
found to exceed the Derived Minimal Effect Levels
(DMEL) ( 3 ) determined for benzo[a]pyrene, which was
Having regard to Regulation (EC) No 1907/2006 of the
used as surrogate for the toxicity of the other PAHs.
European Parliament and of the Council of 18 December
2006 concerning the Registration, Evaluation, Authorisation
and Restriction of Chemicals (REACH), establishing a
(6) The
Commission
evaluated
the
information
provided
by
European Chemicals Agency, amending Directive 1999/45/EC
Germany and concluded on the existence of a risk to
and repealing Council Regulation (EEC) No 793/93 and
consumers posed by articles containing PAHs, indicating
Commission Regulation (EC) No 1488/94 as well as Council
that a restriction would limit the risk. The Commission
Directive 76/769/EEC and Commission Directives 91/155/EEC,
also consulted industry and other stakeholders on the
93/67/EEC, 93/105/EC and 2000/21/EC ( 1 ), and in particular
impact of restricting the presence of PAHs in articles
Article 68(2) thereof,
that could be used by consumers.
Whereas:
(7)
In order to protect the health of consumers from the risk
arising from exposure to PAHs in articles, limits on the
(1) Benzo[a]pyrene,
Benzo[e]pyrene,
Benzo[a]anthracene,
PAH content in the accessible plastic or rubber parts of
Chrysen, Benzo[b]fluoranthene, Benzo[j]fluoranthene,
articles should be set, and the placing on the market of
Benzo[k]fluoranthene and Dibenzo[a,h]anthracene, here
articles containing any of the PAHs in concentrations
inafter referred to as polycyclic aromatic hydrocarbons
greater than 1 mg/kg in those parts should be prohibited.
(PAHs), are classified as carcinogens of category 1B in
accordance with Annex VI to Regulation (EC) No
1272/2008 of the European Parliament and the
(8) Taking
into
account
the
vulnerability
of
children
a
lower
Council of 16 December 2008 on classification,
limit value should be established. Therefore the placing
labelling and packaging of substances and mixtures,
on the market of toys and childcare articles, containing
amending and repealing Directives 67/548/EEC and
any of the PAHs in concentrations greater than
1999/45/EC, and amending Regulation (EC) No
0,5 mg/kg in their accessible plastic or rubber parts,
1907/2006 ( 2 ).
should be prohibited.
(2) These
PAHs
can
be
found
in
the
plastic
and
rubber
parts
of a wide range of consumer articles. They are present as
(9) This
restriction
should
only
apply
to
those
parts
of
impurities in some of the raw materials used in the
articles that come into direct as well as prolonged or
production of such articles, in particular in extender
short-term repetitive contact with the human skin or
oils and in carbon black. They are not added inten
the oral cavity under normal or reasonably foreseeable
tionally to the articles and do not perform any specific
conditions of use. Articles or parts thereof which are
function as constituents of the plastic or rubber parts.
only in short and infrequent contact with the skin or
oral cavity should not be included within the scope of
the restriction as the resulting exposure to PAHs would
(3)
These PAHs are banned for the sale to the general public
as substances on their own or in mixtures by entry 28 of
be insignificant. Further guidance in this respect should
Annex XVII to Regulation (EC) No 1907/2006.
be developed.
Moreover, entry 50 of Annex XVII to that Regulation
restricts the presence of PAHs in extender oils used for
the manufacture of tyres.
(10) Alternative
raw
materials
containing
low
levels
of
PAHs
have been identified in the Union market. Those include
carbon black and oils meeting the requirements of
(4) Information
submitted
by
Germany
to
the
Commission
Commission Regulation (EU) No 10/2011 of 14 January
indicates that articles containing PAHs may pose a risk to
2011 on plastic materials and articles intended to come
consumers’ health by ingestion, dermal adsorption and,
into contact with food ( 4 ).
in some cases, by inhalation.
( 3 ) http://www.echa.europa.eu/documents/10162/13643/information_
( 1 ) OJ L 396, 30.12.2006, p. 1.
requirements_part_b_en.pdf
( 2 ) OJ L 353, 31.12.2008, p. 1.
( 4 ) OJ L 12, 15.1.2011, p. 1.

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L 328/70
EN
Official Journal of the European Union
7.12.2013
(11) The
Commission
should
review
the
existing
limit
values
restriction should not apply to articles placed on the
adopted in this restriction in particular in the light of
market for the first time before that date.
new scientific information, including information on
the migration of PAHs from plastic and rubber
(15) The
measures
provided
for
in
this
Regulation
are
in
materials of the articles covered, as well as on alternative
accordance with the opinion of the Committee estab
raw materials. The availability and reliability of testing
lished under Article 133 of Regulation (EC) No
methods should also be considered in this review of
1907/2006,
new scientific information.
HAS ADOPTED THIS REGULATION:
(12) Regulation
(EC) No 1907/2006 should therefore be
amended accordingly.
Article 1
Annex XVII to Regulation (EC) No 1907/2006 is amended in
(13) It
is
appropriate
to
provide
for
a
reasonable
period
of
accordance with the Annex to this Regulation.
time for the stakeholders concerned to take the measures
that may be required to comply with the measures set
out in this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day
(14) A restriction on the placing on the market of second-
following that of its publication in the Official Journal of the
hand articles and articles that are in the supply chain at
European Union.
the date of entry into application of this Regulation could
pose difficulties for enforcement. Therefore, the
It shall apply from 27 December 2015.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 December 2013.
For the Commission
The President
José Manuel BARROSO

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EN
7.12.2013 Official
Journal
of
the
European
Union L
328/71
ANNEX
In Annex XVII to Regulation (EC) No 1907/2006, in Column 2 of entry 50, the following paragraphs 5, 6, 7 and 8 are
added:
‘5. Articles shall not be placed on the market for supply to the general public, if any
of their rubber or plastic components that come into direct as well as prolonged or
short-term repetitive contact with the human skin or the oral cavity, under normal or
reasonably foreseeable conditions of use, contain more than 1 mg/kg (0,0001 % by
weight of this component) of any of the listed PAHs.
Such articles include amongst others:
— sport equipment such as bicycles, golf clubs, racquets
— household utensils, trolleys, walking frames
— tools for domestic use
— clothing, footwear, gloves and sportswear
— watch-straps, wrist-bands, masks, head-bands
6. Toys,
including
activity
toys,
and
childcare
articles,
shall
not
be
placed
on
the
market, if any of their rubber or plastic components that come into direct as well as
prolonged or short-term repetitive contact with the human skin or the oral cavity, under
normal or reasonably foreseeable conditions of use, contain more than 0,5 mg/kg
(0,00005 % by weight of this component) of any of the listed PAHs.
7. By
way
of
derogation
from
paragraphs
5
and
6,
these
paragraphs
shall
not
apply
to articles placed on the market for the first time before 27 December 2015.
8.
By 27 December 2017, the Commission shall review the limit values in paragraphs
5 and 6 in the light of new scientific information, including migration of PAHs from the
articles referred to therein, and information on alternative raw materials and, if appro
priate, modify these paragraphs accordingly.’

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