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Laws and regulations 30 March 2009
New EU cosmetics regulation: whats changing?
The European Parliament has adopted a final project to recast the European Unions
legislation on cosmetics. The new text changes the rules applicable to nano-materials
used in cosmetics, claims made for products, CMRs and in-market controls.
2/1/12 Premium Beauty News - New EU cosmetics regulation: whats changing?
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MEP Dagmar Roth-
8ehrendt rapporteur on
the recast oI EU
IegIsIatIon on cosmetIcs
AIter one readIng, the European ParIIament agreed on 24 March 2009 on a compromIse
text negotIated together wIth the CouncII and aImIng at sImpIIIyIng procedures whIIe
strengthenIng certaIn eIements oI the reguIatory Iramework Ior cosmetIcs.
A ReguIatIon to repIace the DIrectIve
The new IegIsIatIon wIII take the Iorm oI a European ReguIatIon, makIng It ImmedIateIy
enIorceabIe as Iaw In aII EU member states sImuItaneousIy. At the dIIIerence oI the
DIrectIve currentIy appIIcabIe to cosmetIc products [1], the new text wIII not need to be
transposed Into natIonaI Iaw In each member states, thus not gIvIng room Ior dIvergIng
InterpretatIons.
Strengthened In-market controI
As part oI the sImpIIIIcatIon oI admInIstratIve procedures, the text creates a sIngIe EU-
wIde regIster Ior cosmetIc products and Increases the cooperatIon between market
surveIIIance authorItIes.
Ìn repIacement oI the varIous natIonaI procedures, the text Introduces an EU-wIde
compuIsory notIIIcatIon system oI cosmetIc products, IncIudIng the obIIgatIon to decIare
the presence oI substances In the Iorm oI nanomaterIaIs beIore pIacIng products on the
market. The requIred InIormatIon wIII be transmItted to the CommIssIon through
eIectronIc means.
UndesIrabIe sIde eIIects Induced by cosmetIc products wIII aIso be monItored at the
European scaIe.
CompuIsory IabeIIIng and saIety assessment oI nanomaterIaIs
For the IIrst tIme ever, a European IegIsIatIon addresses nanopartIcIes as such. As
requested by the European ParIIament, the new reguIatIon Introduces a saIety
assessment procedure Ior aII products contaInIng nanomaterIaIs, whIch couId Iead to a
ban on a substance II there Is a rIsk to human heaIth.
CosmetIc products contaInIng nanopartIcuIes wIII have to be notIIIed to the CommIssIon
sIx months prIor beIng pIaced on the market. Ìn case oI concern regardIng the saIety oI
2/1/12 Premium Beauty News - New EU cosmetics regulation: whats changing?
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a nanomaterial, the Commision will have to seize the Scientific Committee on Consumer
Safety [http://www.premiumbeautynews.com/The-European-Commission,204] (SCCS
[http://www.premiumbeautynews.com/The-European-Commission,204]) for giving an
opinion.
Members of European Parliament (MEPs) also pushed successfully for any nanomaterials
present in cosmetics to be mentioned in the list of ingredients on the packaging. In the
list of ingredients, concerned substances will be followed by the word “nano” in brackets
(e.g.: Titanium dioxyde [nano]).
MEPs have also introduced a definition of a nanomaterial as “an insoluble or bioresistant
and intentionall manufactured material ith one or more eternal dimensions, or an
internal structure, on the scale from 1 to 100 nm.”
This is the first time that a definition of nanomaterials is introduced in European law.
The Commission will have to adapt this definition in line with scientific and technological
advances. However, environmental organisations and the BEUC [http://www.beuc.org/],
the European consumers organisation, have criticised the s narrowness of the
definitions scope.
Common criteria for product claims
On the use of product claims for cosmetics, the Commission is asked to adopt a list
determining common criteria. Such a list aims at harmonising the opinion of public
authorities in the various member states concerning what claims are acceptable or
unacceptable for cosmetic products.
Stricter rules on CMR substances
The regulation provides for strict rules for the use of substances which are carcinogenic,
mutagenic or toxic for reproduction (CMR). The use of those substances is basically
forbidden in cosmetics and they can only be used in exceptional cases under strict
conditions, which have been tightened up by the compromise.
The proposed text also addresses substances with endocrine-disrupting properties, that
will be regulated when European or internationally agreed criteria for identifying them
or at the latest five years after the Regulation has entered into force.
Ban on animal testing unchanged
The existing provisions banning animal testing for finished cosmetic products as of
2004, with a phasing-out period for animal tests on cosmetic ingredients by 2009/2013,
are unaffected by the new regulation
Final steps
MEPs adopted the proposed regulation with 633 votes in favour, 29 against with 11
abstentions. The Council must now approve the same text so that it becomes law and
comes into effect in 2012
Download text here:
2/1/12 Premium Beauty News - New EU cosmetics regulation: whats changing?
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Recast of
cosmetic
products
legislation
Vincent Gallon
Footnotes
[1] Directive 76/768/EEC of 27 July 1976 and its several amendments
© 2009 - Premium Beauty News - www.premiumbeautynews.com
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Such a list aims at harmonising the opinion of public authorities in the various member states concerning what claims are acceptable or unacceptable for cosmetic products. the Commision will have to seize the Scientific Committee on Consumer Safety [http://www.com/The-European-Commission. Stricter rules on CMR substances The regulation provides for strict rules for the use of substances which are carcinogenic. However. environmental organisations and the BEUC [http://www. Ban on animal testing unchanged The existing provisions banning animal testing for finished cosmetic products as of 2004. MEPs have also introduced a definition of a nanomaterial as “an insoluble or bioresistant and intentionall manufactured material ith one or more e ternal dimensions.New EU cosmetics regulation: what s changing? a nanomaterial. In the list of ingredients. are unaffected by the new regulation Final steps MEPs adopted the proposed regulation with 633 votes in favour. The Commission will have to adapt this definition in line with scientific and technological advances.com/en/New-EU-cosmetics-regulation-what-s.com/The-European-Commission. or an internal structure.2/1/12 Premium Beauty News . the European consumers organisation.204] (SCCS [http://www.beuc.premiumbeautynews. have criticised the s narrowness of the definition s scope. on the scale from 1 to 100 nm. The proposed text also addresses substances with endocrine-disrupting properties.7… 3/7 . with a phasing-out period for animal tests on cosmetic ingredients by 2009/2013.204]) for giving an opinion. The use of those substances is basically forbidden in cosmetics and they can only be used in exceptional cases under strict conditions. mutagenic or toxic for reproduction (CMR).premiumbeautynews.: Titanium dioxyde [nano]). 29 against with 11 abstentions. Common criteria for product claims On the use of product claims for cosmetics.” This is the first time that a definition of nanomaterials is introduced in European law.premiumbeautynews. The Council must now approve the same text so that it becomes law and comes into effect in 2012 Download text here: www. the Commission is asked to adopt a list determining common criteria. which have been tightened up by the compromise. concerned substances will be followed by the word “nano” in brackets (e.g. Members of European Parliament (MEPs) also pushed successfully for any nanomaterials present in cosmetics to be mentioned in the list of ingredients on the packaging. that will be regulated when European or internationally agreed criteria for identifying them or at the latest five years after the Regulation has entered into force.org/].

.com Li e | more | latest news 01/31/2012Timotei launches first certified organic range 01/31/2012France: the selective perfumery ends year with a flourish 01/31/2012Russia: The new cosmetic regulations will soon come into force 01/31/2012Airless packaging: high expectations 01/30/2012Robert Bergman designs a Multi-Task bottle for Pureology 01/30/2012Sustainable development.com/en/New-EU-cosmetics-regulation-what-s..) read more job opportunities www. a strategic focus for the entire beauty industry Focus Airless packaging: high expectations Over 90 people attended the conference “Which airless for which formula” organized by Premium Beauty News on January 26 at the Aero Club de France in Paris.premiumbeautynews.7… 4/7 .2/1/12 Premium Beauty News . technical and marketing issues related to the development (.Premium Beauty News .New EU cosmetics regulation: what s changing? Recast of cosmetic products legislation Vincent Gallon Footnotes [1] Directive 76/768/EEC of 27 July 1976 and its several amendments © 2009 . panel discussions and debates achieved a comprehensive picture of the regulatory.premiumbeautynews.www. The various presentations.

. Europe s leading supplier of high quality folding boxboards.. says Katri Kauppila 10/16/2011 premiumbeautynews.) M-real “We address the specific needs of the beauty industry”.) www.Groupe Fareva Assistant(e) Achat Packaging latest success stories M-real Lightweight drives luxury on the way to sustainability 10/17/2011 premiumbeautynews.7… 5/7 .New EU cosmetics regulation: what s changing? confidential Acheteur Matières Premières Junior H/F Cadres & Tech Un(e) Directeur de Clientèle Packaging de Luxe France HCP Packaging France Key Account Manager (H/F) Institut Caméane / Arcancil H/F Responsable Achats Centragroup Fareva ..2/1/12 Premium Beauty News .. cost efficient and environmental-friendly (.com/en/New-EU-cosmetics-regulation-what-s.com For M-real Consumer Packaging. there is no doubt that luxury can go hand in hand with sustainability. The Finnish cartonboard (.com Lightweight carton boards from fresh Nordic forest fibres are a key component of M-real s strategy to provide its customers with high-performance.premiumbeautynews.

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. “Meeting the challenge of the 2014 IFSCC (..New EU cosmetics regulation: what s changing? Industry buzz Timotei launches first certified organic range France: the selective perfumery ends year with a flourish Robert Bergman designs a ‘Multi-Task’ bottle for Pureology Shiseido steps into Tunisia Brenntag enters flavours and fragrance business in Latin America Go to top Features Markets & trends Russia: the distribution issue Stylesight’s views on beauty trends Laws and regulations Russia: The new cosmetic regulations will soon come into force Animal testing: The other serial of the season Science...com/en/New-EU-cosmetics-regulation-what-s.2/1/12 Premium Beauty News .. 26 January 2012 Managing the container/content interactions in cosmetics Packaging & design Airless packaging: high expectations Weckerle: Growth on all fronts Environment Sustainable development.) Ingredients & formulation Which airless for which formula? Paris. R&D Interactions between skin and formulations the main theme of the Jean-Paul Marty (. a strategic focus for the entire beauty industry “Environmental concerns are transforming hotel cosmetics.” Marie-Cécile (.premiumbeautynews.) Innovation & new products Scentys pulls out its creator’s cartridges L’Oréal goes a step further in its relationship with its suppliers Companies & industry Florida: Oxygen’s new plant is operational! Oekabeauty: New investments in 2012 chargement www.) Étienne Soudant.7… 7/7 .. SFC.