委员会条例(EU) No 655/2013 ,为化妆品使用合理性声明制定通用标准
技术法规类型:欧盟Eurlex法规 来源:tbtmap
EURLEX ID:32013R0655
OJ编号:OJ L 190, 11.7.2013, p. 31-34
中文标题:委员会条例(EU) No 655/2013 ,为化妆品使用合理性声明制定通用标准
原文标题:Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products (1)
分类:15.20.20_消费者信息、教育与表现
文件类型:二级立法 Regulation|条例
生效日期:2013-07-12
废止日期:2058-12-31
法规全文:查看欧盟官方文件
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11.7.2013 Official
Journal
of
the
European
Union L
190/31
COMMISSION REGULATION (EU) No 655/2013
of 10 July 2013
laying down common criteria for the justification of claims used in relation to cosmetic products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) Article
20
of
Regulation
(EC)
No
1223/2009
applies
to
products that fall under the definition of a cosmetic
product in Article 2 of this Regulation. The common
criteria only apply when it has been assessed that the
Having regard to the Treaty on the Functioning of the European
product in question is indeed a cosmetic product. It is
Union,
for the national competent authorities and national
courts to decide on a case-by-case basis which regulatory
framework applies.
Having regard to Regulation (EC) No 1223/2009 of the
European Parliament and of the Council of 30 November
2009 on cosmetic products ( 1 ), and in particular the second
(5) The
common
criteria
should
apply
without
prejudice
to
subparagraph of Article 20(2) thereof,
Directive 2005/29/EC of the European Parliament and of
the Council of 11 May 2005 concerning unfair business-
to-consumer commercial practices in the internal market
and amending Council Directive 84/450/EEC, Directives
Whereas:
97/7/EC, 98/27/EC and 2002/65/EC of the European
Parliament and of the Council and Regulation (EC) No
2006/2004 of the European Parliament and of the
Council (‘Unfair Commercial Practices Directive’) (
(1) End
users
as
defined
in
Article
2(1)(f)
of
Regulation
(EC)
3 ), to
No 1223/2009 are faced with a wide diversity of claims
Directive 2006/114/EC of the European Parliament and
relating to the function, content and effects of a cosmetic
of the Council of 12 December 2006 concerning
product. As cosmetic products play such a big part in
misleading and comparative advertising ( 4 ), and to other
end users’ lives, it is important to ensure that the
applicable Union legislation.
information conveyed to them through such claims is
useful, understandable and reliable, and that it enables
them to take informed decisions and to choose the
(6) A
flexible
approach
should
be
taken
towards
communi
products that best suit their needs and expectations.
cating the messages to end users so as to take into
account the social, linguistic and cultural diversity of
the Union and to preserve the innovation and the
competitiveness of European industry. Such an
(2) Product
claims
of
cosmetic
products
serve
mainly
to
approach is consistent with the principles enunciated
inform end users about the characteristics and qualities
by the Court of Justice, which has pointed out on
of the products. Those claims are essential ways of differ
several occasions that, in order to determine whether a
entiating between products. They also contribute to
claim is capable of misleading the consumer, it is
stimulating innovation and fostering competition.
necessary to consider the latter’s expectations, taking
account of the specific context and circumstances in
which the claim is made, including social, cultural and
(3) Common
criteria
should
be
laid
down
at
Union
level
in
linguistic factors ( 5 ).
order to justify the use of a claim made in relation to
cosmetic products. The main objective of laying down
common criteria is to guarantee a high level of
protection for end users, in particular from misleading
(7) Whilst
ensuring
that
the
same
principles
are
respected
claims in relation to cosmetic products. A common
throughout the Union, the common criteria should not
approach at Union level should also ensure better
aim at defining and specifying the wording that can be
convergence of actions taken by the Member States’
used for cosmetic product claims.
competent authorities, and prevent distortions in the
internal market. Such an approach should also enhance
cooperation between national authorities responsible for
the enforcement of consumer protection as laid down in
(8) In
order
to
ensure
that
the
common
criteria
for
cosmetic
Regulation (EC) No 2006/2004 of the European
claims apply from the same date as Regulation (EC) No
Parliament and of the Council of 27 October 2004 on
1223/2009, this Regulation should apply from 11 July
cooperation between national authorities responsible for
2013.
the enforcement of consumer protection laws (the Regu
lation on consumer protection cooperation) ( 2 ).
( 3 ) OJ L 149, 11.6.2005, p. 22.
( 4 ) OJ L 376, 27.12.2006, p. 21.
( 1 ) OJ L 342, 22.12.2009, p. 59.
( 5 ) See e.g. Case C-220/98, Estée Lauder Cosmetics vs. Lancaster [2000]
( 2 ) OJ L 364, 9.12.2004, p. 1.
ECR I-00117, paragraph 29.
L 190/32
EN
Official Journal of the European Union
11.7.2013
(9) The
measures
provided
for
in
this
Regulation
are
in
Article 2
accordance with the opinion of the Standing
Committee on Cosmetic Products,
The responsible person referred to in Article 4 of Regulation
(EC) No 1223/2009 shall ensure that the wording of the claim
in relation to cosmetic products is in compliance with the
HAS ADOPTED THIS REGULATION:
common criteria set out in the Annex and is consistent with
the documentation proving the effect claimed for the cosmetic
Article 1
product in the product information file referred to in Article 11
of Regulation (EC) No 1223/2009.
This Regulation shall apply to claims in the form of texts,
names, trademarks, pictures and figurative or other signs that
Article 3
convey explicitly or implicitly product characteristics or
functions in the labelling, the making available on the market
This Regulation shall enter into force on the day following that
and advertising of cosmetic products. It shall apply to any
of its publication in the Official Journal of the European Union.
claim, irrespective of the medium or type of marketing tool
used, the product functions claimed, and the target audience.
It shall apply from 11 July 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 July 2013.
For the Commission
The President
José Manuel BARROSO
EN
11.7.2013 Official
Journal
of
the
European
Union L
190/33
ANNEX
COMMON CRITERIA
1. Legal compliance
(1) Claims that indicate that the product has been authorised or approved by a competent authority within the Union
shall not be allowed.
(2) The acceptability of a claim shall be based on the perception of the average end user of a cosmetic product, who is
reasonably well-informed and reasonably observant and circumspect, taking into account social, cultural and
linguistic factors in the market in question.
(3) Claims which convey the idea that a product has a specific benefit when this benefit is mere compliance with
minimum legal requirements shall not be allowed.
2. Truthfulness
(1) If it is claimed on the product that it contains a specific ingredient, the ingredient shall be deliberately present.
(2) Ingredient claims referring to the properties of a specific ingredient shall not imply that the finished product has
the same properties when it does not.
(3) Marketing communications shall not imply that expressions of opinions are verified claims unless the opinion
reflects verifiable evidence.
3. Evidential support
(1) Claims for cosmetic products, whether explicit or implicit, shall be supported by adequate and verifiable evidence
regardless of the types of evidential support used to substantiate them, including where appropriate expert
assessments.
(2) Evidence for claim substantiation shall take into account state of the art practices.
(3) Where studies are being used as evidence, they shall be relevant to the product and to the benefit claimed, shall
follow well-designed, well-conducted methodologies (valid, reliable and reproducible) and shall respect ethical
considerations.
(4) The level of evidence or substantiation shall be consistent with the type of claim being made, in particular for
claims where lack of efficacy may cause a safety problem.
(5) Statements of clear exaggeration which are not to be taken literally by the average end user (hyperbole) or
statements of an abstract nature shall not require substantiation.
(6) A claim extrapolating (explicitly or implicitly) ingredient properties to the finished product shall be supported by
adequate and verifiable evidence, such as by demonstrating the presence of the ingredient at an effective concen
tration.
(7) Assessment of the acceptability of a claim shall be based on the weight of evidence of all studies, data and
information available depending on the nature of the claim and the prevailing general knowledge the end users.
4. Honesty
(1) Presentations of a product’s performance shall not go beyond the available supporting evidence.
(2) Claims shall not attribute to the product concerned specific (i.e. unique) characteristics if similar products possess
the same characteristics.
(3) If the action of a product is linked to specific conditions, such as use in association with other products, this shall
be clearly stated.
5. Fairness
(1) Claims for cosmetic products shall be objective and shall not denigrate the competitors, nor shall they denigrate
ingredients legally used.
(2) Claims for cosmetic products shall not create confusion with the product of a competitor.
L 190/34
EN
Official Journal of the European Union
11.7.2013
6. Informed decision-making
(1) Claims shall be clear and understandable to the average end user.
(2) Claims are an integral part of products and shall contain information allowing the average end user to make an
informed choice.
(3) Marketing communications shall take into account the capacity of the target audience (population of relevant
Member States or segments of the population, e.g. end users of different age and gender) to comprehend the
communication. Marketing communications shall be clear, precise, relevant and understandable by the target
audience.
11.7.2013 Official
Journal
of
the
European
Union L
190/31
COMMISSION REGULATION (EU) No 655/2013
of 10 July 2013
laying down common criteria for the justification of claims used in relation to cosmetic products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) Article
20
of
Regulation
(EC)
No
1223/2009
applies
to
products that fall under the definition of a cosmetic
product in Article 2 of this Regulation. The common
criteria only apply when it has been assessed that the
Having regard to the Treaty on the Functioning of the European
product in question is indeed a cosmetic product. It is
Union,
for the national competent authorities and national
courts to decide on a case-by-case basis which regulatory
framework applies.
Having regard to Regulation (EC) No 1223/2009 of the
European Parliament and of the Council of 30 November
2009 on cosmetic products ( 1 ), and in particular the second
(5) The
common
criteria
should
apply
without
prejudice
to
subparagraph of Article 20(2) thereof,
Directive 2005/29/EC of the European Parliament and of
the Council of 11 May 2005 concerning unfair business-
to-consumer commercial practices in the internal market
and amending Council Directive 84/450/EEC, Directives
Whereas:
97/7/EC, 98/27/EC and 2002/65/EC of the European
Parliament and of the Council and Regulation (EC) No
2006/2004 of the European Parliament and of the
Council (‘Unfair Commercial Practices Directive’) (
(1) End
users
as
defined
in
Article
2(1)(f)
of
Regulation
(EC)
3 ), to
No 1223/2009 are faced with a wide diversity of claims
Directive 2006/114/EC of the European Parliament and
relating to the function, content and effects of a cosmetic
of the Council of 12 December 2006 concerning
product. As cosmetic products play such a big part in
misleading and comparative advertising ( 4 ), and to other
end users’ lives, it is important to ensure that the
applicable Union legislation.
information conveyed to them through such claims is
useful, understandable and reliable, and that it enables
them to take informed decisions and to choose the
(6) A
flexible
approach
should
be
taken
towards
communi
products that best suit their needs and expectations.
cating the messages to end users so as to take into
account the social, linguistic and cultural diversity of
the Union and to preserve the innovation and the
competitiveness of European industry. Such an
(2) Product
claims
of
cosmetic
products
serve
mainly
to
approach is consistent with the principles enunciated
inform end users about the characteristics and qualities
by the Court of Justice, which has pointed out on
of the products. Those claims are essential ways of differ
several occasions that, in order to determine whether a
entiating between products. They also contribute to
claim is capable of misleading the consumer, it is
stimulating innovation and fostering competition.
necessary to consider the latter’s expectations, taking
account of the specific context and circumstances in
which the claim is made, including social, cultural and
(3) Common
criteria
should
be
laid
down
at
Union
level
in
linguistic factors ( 5 ).
order to justify the use of a claim made in relation to
cosmetic products. The main objective of laying down
common criteria is to guarantee a high level of
protection for end users, in particular from misleading
(7) Whilst
ensuring
that
the
same
principles
are
respected
claims in relation to cosmetic products. A common
throughout the Union, the common criteria should not
approach at Union level should also ensure better
aim at defining and specifying the wording that can be
convergence of actions taken by the Member States’
used for cosmetic product claims.
competent authorities, and prevent distortions in the
internal market. Such an approach should also enhance
cooperation between national authorities responsible for
the enforcement of consumer protection as laid down in
(8) In
order
to
ensure
that
the
common
criteria
for
cosmetic
Regulation (EC) No 2006/2004 of the European
claims apply from the same date as Regulation (EC) No
Parliament and of the Council of 27 October 2004 on
1223/2009, this Regulation should apply from 11 July
cooperation between national authorities responsible for
2013.
the enforcement of consumer protection laws (the Regu
lation on consumer protection cooperation) ( 2 ).
( 3 ) OJ L 149, 11.6.2005, p. 22.
( 4 ) OJ L 376, 27.12.2006, p. 21.
( 1 ) OJ L 342, 22.12.2009, p. 59.
( 5 ) See e.g. Case C-220/98, Estée Lauder Cosmetics vs. Lancaster [2000]
( 2 ) OJ L 364, 9.12.2004, p. 1.
ECR I-00117, paragraph 29.
L 190/32
EN
Official Journal of the European Union
11.7.2013
(9) The
measures
provided
for
in
this
Regulation
are
in
Article 2
accordance with the opinion of the Standing
Committee on Cosmetic Products,
The responsible person referred to in Article 4 of Regulation
(EC) No 1223/2009 shall ensure that the wording of the claim
in relation to cosmetic products is in compliance with the
HAS ADOPTED THIS REGULATION:
common criteria set out in the Annex and is consistent with
the documentation proving the effect claimed for the cosmetic
Article 1
product in the product information file referred to in Article 11
of Regulation (EC) No 1223/2009.
This Regulation shall apply to claims in the form of texts,
names, trademarks, pictures and figurative or other signs that
Article 3
convey explicitly or implicitly product characteristics or
functions in the labelling, the making available on the market
This Regulation shall enter into force on the day following that
and advertising of cosmetic products. It shall apply to any
of its publication in the Official Journal of the European Union.
claim, irrespective of the medium or type of marketing tool
used, the product functions claimed, and the target audience.
It shall apply from 11 July 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 July 2013.
For the Commission
The President
José Manuel BARROSO
EN
11.7.2013 Official
Journal
of
the
European
Union L
190/33
ANNEX
COMMON CRITERIA
1. Legal compliance
(1) Claims that indicate that the product has been authorised or approved by a competent authority within the Union
shall not be allowed.
(2) The acceptability of a claim shall be based on the perception of the average end user of a cosmetic product, who is
reasonably well-informed and reasonably observant and circumspect, taking into account social, cultural and
linguistic factors in the market in question.
(3) Claims which convey the idea that a product has a specific benefit when this benefit is mere compliance with
minimum legal requirements shall not be allowed.
2. Truthfulness
(1) If it is claimed on the product that it contains a specific ingredient, the ingredient shall be deliberately present.
(2) Ingredient claims referring to the properties of a specific ingredient shall not imply that the finished product has
the same properties when it does not.
(3) Marketing communications shall not imply that expressions of opinions are verified claims unless the opinion
reflects verifiable evidence.
3. Evidential support
(1) Claims for cosmetic products, whether explicit or implicit, shall be supported by adequate and verifiable evidence
regardless of the types of evidential support used to substantiate them, including where appropriate expert
assessments.
(2) Evidence for claim substantiation shall take into account state of the art practices.
(3) Where studies are being used as evidence, they shall be relevant to the product and to the benefit claimed, shall
follow well-designed, well-conducted methodologies (valid, reliable and reproducible) and shall respect ethical
considerations.
(4) The level of evidence or substantiation shall be consistent with the type of claim being made, in particular for
claims where lack of efficacy may cause a safety problem.
(5) Statements of clear exaggeration which are not to be taken literally by the average end user (hyperbole) or
statements of an abstract nature shall not require substantiation.
(6) A claim extrapolating (explicitly or implicitly) ingredient properties to the finished product shall be supported by
adequate and verifiable evidence, such as by demonstrating the presence of the ingredient at an effective concen
tration.
(7) Assessment of the acceptability of a claim shall be based on the weight of evidence of all studies, data and
information available depending on the nature of the claim and the prevailing general knowledge the end users.
4. Honesty
(1) Presentations of a product’s performance shall not go beyond the available supporting evidence.
(2) Claims shall not attribute to the product concerned specific (i.e. unique) characteristics if similar products possess
the same characteristics.
(3) If the action of a product is linked to specific conditions, such as use in association with other products, this shall
be clearly stated.
5. Fairness
(1) Claims for cosmetic products shall be objective and shall not denigrate the competitors, nor shall they denigrate
ingredients legally used.
(2) Claims for cosmetic products shall not create confusion with the product of a competitor.
L 190/34
EN
Official Journal of the European Union
11.7.2013
6. Informed decision-making
(1) Claims shall be clear and understandable to the average end user.
(2) Claims are an integral part of products and shall contain information allowing the average end user to make an
informed choice.
(3) Marketing communications shall take into account the capacity of the target audience (population of relevant
Member States or segments of the population, e.g. end users of different age and gender) to comprehend the
communication. Marketing communications shall be clear, precise, relevant and understandable by the target
audience.
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