Commission Regulation (EU) No 866/2014

of 8 August 2014

amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products1, and in particular Article 31(2) thereof,

Whereas:

(1)

The substances identified by the denominations alkyl (C12-22) trimethyl ammonium bromide and chloride are regulated as preservatives under entry 44 of Annex V to Regulation (EC) No 1223/2009 with a maximum concentration of 0,1 %.

(2)
The Scientific Committee on Consumer Products (‘SCCP’), subsequently replaced by the Scientific Committee on Consumer Safety (‘SCCS’) pursuant to Commission Decision 2008/721/EC2, evaluated the safety of alkyl (C16, C18, C22) trimethylammonium chloride (cetrimonium chloride, steartrimonium chloride and behentrimonium chloride) for other uses than as preservatives in 2005, 2007 and 2009.
(3)
The SCCS concluded in its opinion of 8 December 20093 that, apart from the fact that quaternary ammonium derivative formulations have the potential to be skin irritants, especially when combinations of the concerned compounds are used, the use of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride does not pose a risk to the health of the consumer in concentrations below certain limits, which are explicitly set out in the SCCS opinion.
(4)

In order to take into account the skin irritation potential of the combinations of the quaternary ammonium derivatives mentioned above, the Commission considers that, while allowing the use of these substances for other uses than as preservatives at higher concentrations, the sums of these substances should be restricted to the maximum concentration indicated by the SCCS for the individual substances.

(5)

The maximum concentrations indicated by the SCCS as safe for leave-on facial cream products should apply to all leave-on face products, as there is no reason to limit authorisation of those substances to leave-on face creams only.

(6)

New entries in Annex III to Regulation (EC) No 1223/2009 should therefore be added to reflect the above-mentioned considerations, and entry 44 in Annex V should cross-refer to the new entries in Annex III, so that those Annexes are adapted to technical and scientific progress.

(7)
The SCCS evaluated the safety of the mixture citric acid (and) silver citrate. In its opinion of 13 October 20094, it stated that, on the basis of the data submitted, the use of that mixture as a preservative in cosmetic products, at a concentration up to 0,2 % (corresponding to a silver concentration of 0,0024 %), does not pose a risk to the health of the consumer. The Committee specified that the substance was safe when used at the same maximum concentration in deodorants and anti-perspirants, as a preservative and/or an active ingredient. Its use in oral and eye products was, however, explicitly excluded given that only dermal exposure was assessed.
(8)

A new entry in Annex V to Regulation (EC) No 1223/2009 should be added to reflect the above-mentioned considerations and to adapt it to technical and scientific progress.

(9)
The SCCS assessed tris-biphenyl triazine, which is a UV-filter and a nanomaterial. In its opinion of 20 September 20115, it concluded that dermal exposure to formulations containing tris-biphenyl triazine with a mean particle size (median primary particle size) of 81 nm results in low absorption of that substance. Also after oral exposure, absorption of tris-biphenyl triazine is low. No systemic effects are observed after oral or dermal exposure up to 500 mg/kg bw/day. The data analysed by the SCCS leads to the conclusion that the use of 10 % tris-biphenyl triazine, including as nanomaterial, as a UV-filter in cosmetic products can be considered safe for dermal application.
(10)

However, the SCCS clarified that, at the time of the risk assessment, there was too much uncertainty to conclude about safe use of 10 % tris-biphenyl triazine in spray applications, because of concerns over possible inhalation exposure. Therefore, the SCCS concluded that spray products containing tris-biphenyl triazine cannot be recommended until additional information on safety after repeated inhalation is provided.

(11)

In light of the SCCS opinion and taking into account that the use of nanomaterials can improve the efficiency of UV-filters, Annex VI to Regulation (EC) No 1223/2009 should be amended for the purpose of adapting it to technical and scientific progress.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes III, V and VI to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

X1ANNEX

Annexes III, V and VI to Regulation (EC) No 1223/2009 are amended as follows:

  1. (1)

    In Annex III, the following entries 286 and 287 are added:

    Substance Identification

    Conditions

    Reference number

    Chemical name/INN

    Name of Common Ingredients Glossary

    CAS number

    EC number

    Product type, Body parts

    Maximum concentration in ready for use preparation

    Other

    Wording of conditions of use and warnings

    a

    b

    c

    d

    e

    f

    g

    h

    i

    ‘286

    C 16 -alkyltrimethylammonium chloride

    Cetrimonium chloride6

    112-02-7

    203-928-6

    (a)

    Rinse-off hair products

    (a)

    2,5 % for the individual concentrations or the sum of the individual concentrations of cetrimonium chloride and steartrimonium chloride

    For purposes other than inhibiting the development of micro-organisms in the product. The purpose has to be apparent from the presentation of the product.

    C 18 -alkyltrimethylammonium chloride

    Steartrimonium chloride6

    112-03-8

    203-929-1

    (b)

    Leave-on hair products

    (b)

    1,0 % for the individual concentrations or the sum of the individual concentrations of cetrimonium chloride and steartrimonium chloride

    (c)

    Leave-on face products

    (c)

    0,5 % for the individual concentrations or the sum of the individual concentrations of cetrimonium chloride and steartrimonium chloride

    287

    C 22 -alkyltrimethylammonium chloride

    Behentrimonium chloride6

    17301-53-0

    241-327-0

    (a)

    Rinse-off hair products

    (a)

    5,0 % for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and steartrimonium chloride set out in entry 286.

    For purposes other than inhibiting the development of micro-organisms in the product. The purpose has to be apparent from the presentation of the product.

    (b)

    Leave-on hair products

    (b)

    3,0 % for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and steartrimonium chloride set out in entry 286.

    (c)

    Leave-on face products

    (c)

    3,0 % for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and steartrimonium chloride set out in entry 286.

    6

    For use as a preservative, see Annex V, entry No 44.’

  2. (2)

    Annex V is amended as follows:

    1. (a)

      entry 44 is replaced by the following:

      Substance Identification

      Conditions

      Reference number

      Chemical name/INN

      Name of Common Ingredients Glossary

      CAS number

      EC number

      Product type, Body parts

      Maximum concentration in ready for use preparation

      Other

      Wording of conditions of use and warnings

      a

      b

      c

      d

      e

      f

      g

      h

      i

      ‘44

      Alkyl (C 12-22 ) trimethyl ammonium bromide and chloride

      Behentrimonium chloride7,

      17301-53-0,

      241-327-0,

      0,1 %

      cetrimonium bromide,

      57-09-0,

      200-311-3,

      cetrimonium chloride8,

      112-02-7,

      203-928-6,

      laurtrimonium bromide,

      1119-94-4,

      214-290-3,

      laurtrimonium chloride,

      112-00-5,

      203-927-0,

      steartrimonium bromide,

      1120-02-1,

      214-294-5,

      steartrimonium chloride8

      112-03-8

      203-929-1

      7

      For use other than as a preservative, see Annex III, No 287.

      8

      For use other than as a preservative, see Annex III, No 286.’

    2. (b)

      entry 59 is added:

      Substance Identification

      Conditions

      Reference number

      Chemical name/INN

      Name of Common Ingredients Glossary

      CAS number

      EC number

      Product type, Body parts

      Maximum concentration in ready for use preparation

      Other

      Wording of conditions of use and warnings

      a

      b

      c

      d

      e

      f

      g

      h

      i

      ‘59

      1,2,3-Propanetricarboxylic acid, 2-hydroxy-, monohydrate and 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, silver(1+) salt, monohydrate

      Citric acid (and) Silver citrate

      —

      460-890-5

      0,2 %, corresponding to 0,0024 % of silver

      Not to be used in oral products and eye products’

  3. (3)

    In Annex VI entry 29 is added:

    Substance Identification

    Conditions

    Reference number

    Chemical name/INN

    Name of Common Ingredients Glossary

    CAS number

    EC number

    Product type, Body parts

    Maximum concentration in ready for use preparation

    Other

    Wording of conditions of use and warnings

    a

    b

    c

    d

    e

    f

    g

    h

    i

    ‘29

    1,3,5-Triazine, 2,4,6-tris[1,1'-biphenyl]-4-yl-, including as nanomaterial

    Tris-biphenyl triazine

    Tris-biphenyl triazine (nano)

    31274-51-8

    —

    10 %

    Not to be used in sprays.

    Only nanomaterials having the following characteristics are allowed:

    • median primary particle size > 80 nm;

    • Purity ≥ 98 %;

    • Uncoated ’