title: Commission Directive 2008/62/EC of 20 June 2008 providing for certain derogations for acceptance of agricultural landraces and varieties which are naturally adapted to the local and regional conditions and threatened by genetic erosion and for marketing of seed and seed potatoes of those landraces and varieties (Text with EEA relevance)

text:
               21.6.2008

               EN

               Official Journal of the European Union

               L 162/13

      COMMISSION DIRECTIVE 2008/62/EC
   of 20 June 2008
   providing for certain derogations for acceptance of agricultural landraces and varieties which are naturally adapted to the local and regional conditions and threatened by genetic erosion and for marketing of seed and seed potatoes of those landraces and varieties
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), and in particular Article 22a(1)(b) thereof,
   Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (2), and in particular Article 22a(1)(b) thereof,
   Having regard to Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (3), and in particular Article 4(6), Article 20(2) and Article 21 thereof,
   Having regard to Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed (4), and in particular Article 30(1)(b) thereof,
   Having regard to Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (5), and in particular Article 10(1) and Article 27(1)(b) thereof,
   Having regard to Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (6), and in particular Article 27(1)(b) thereof,
   Whereas:

               (1)

               The questions of biodiversity and the conservation of plant genetic resources have grown in importance in recent years, as shown by different developments at international and Community level. Examples include Council Decision 93/626/EEC of 25 October 1993 concerning the conclusion of the Convention on Biological Diversity (7), Council Decision 2004/869/EC of 24 February 2004 concerning the conclusion, on behalf of the European Community, of the International Treaty on Plant Genetic Resources for Food and Agriculture (8), Council Regulation (EC) No 870/2004 of 24 April 2004 establishing a Community programme on the conservation, characterisation, collection and utilisation of genetic resources in agriculture and repealing Regulation (EC) No 1467/94 (9) and Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (10). Specific conditions should be established under the Community legislation governing the marketing of seed of agricultural plants, namely Directives 66/401/EEC, 66/402/EEC, 2002/53/EC, 2002/54/EC, 2002/56/EC and 2002/57/EC, in order to take account of these issues.

               (2)

               In order to ensure in situ conservation and the sustainable use of plant genetic resources, landraces and varieties which are naturally adapted to local and regional conditions and threatened by genetic erosion (conservation varieties) should be grown and marketed even where they do not comply with the general requirements as regards the acceptance of varieties and the marketing of seed and seed potatoes. In order to achieve that objective it is necessary to provide for derogations as regards the acceptance of conservation varieties, for inclusion in the national catalogues of varieties of agricultural plant species as well as for the production and marketing of seed and seed potatoes of those varieties.

               (3)

               Those derogations should concern the substantive requirements for the acceptance of a variety and the procedural requirements provided for in Commission Directive 2003/90/EC of 6 October 2003 setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species (11).

               (4)

               Member States should, in particular, be authorised to adopt their own provisions as regards distinctness, stability and uniformity. These provisions should, as regards distinctness and stability, at least be based on the characteristics listed in the technical questionnaire to be completed by the applicant in connection with the application for the variety acceptance as referred to in Annexes I and II to Directive 2003/90/EC. Where uniformity is established on the basis of off-types, the provisions should be based on defined standards.

               (5)

               The procedural requirements should be provided for under which a variety may be accepted without official examination. Furthermore, as regards the denomination, it is necessary to provide for certain derogations from the requirements laid down in Directive 2002/53/EC and Commission Regulation (EC) No 930/2000 of 4 May 2000 establishing implementing rules as to the suitability of the denominations of varieties of agricultural plant species and vegetable species (12).

               (6)

               As regards the production and marketing of seed and seed potatoes of conservation varieties, a derogation from official certification should be provided for.

               (7)

               To ensure that the marketing of seed and seed potatoes of conservation varieties takes place in the context of the conservation of plant genetic resources, restrictions should be provided for, in particular regarding the region of origin. In order to contribute to the conservation in situ and to the sustainable use of those varieties, Member States should have the possibility to approve additional regions where seed exceeding the quantities necessary to ensure the conservation of the variety concerned in its region of origin may be marketed provided that those additional regions are comparable as regards natural and semi-natural habitats. To ensure that the link with the region of origin is preserved, this should not apply where a Member State has approved additional regions of production.

               (8)

               Maximum quantities should be fixed for the marketing of each conservation variety within one species and a total quantity for all conservation varieties within one species together. To make sure that these quantities are respected, Member States should require producers to notify the quantities of conservation varieties they intend to produce and should allocate the quantities to producers.

               (9)

               The traceability of seed and seed potatoes should be ensured through appropriate sealing and labelling requirements.

               (10)

               To ensure that the rules provided for in this Directive are correctly applied, seed crops should be monitored, seed should be tested and official post control carried out. Amounts of seed of conservation varieties placed on the market should be reported by the suppliers to the Member States and by the Member States to the Commission.

               (11)

               After three years the Commission should assess whether the measures provided for in this Directive, in particular the provisions concerning quantitative restrictions, are effective.

               (12)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

         HAS ADOPTED THIS DIRECTIVE:
   CHAPTER I
   SUBJECT MATTER AND DEFINITIONS
   Article 1
   Subject matter
   1.   As regards the agricultural species covered by Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/56/EC and 2002/57/EC, this Directive lays down certain derogations in relation to the conservation in situ and the sustainable use of plant genetic resources through growing and marketing:

               (a)

               for acceptance for inclusion in the national catalogues of varieties of agricultural plant species, as provided for in Directive 2002/53/EC, of landraces and varieties which are naturally adapted to the local and regional conditions and threatened by genetic erosion;

               (b)

               for the marketing of seed and seed potatoes of such landraces and varieties.

         2.   Unless otherwise provided in this Directive, Directives 66/401/EEC, 66/402/EEC, 2002/53/EC, 2002/54/EC, 2002/56/EC and 2002/57/EC shall apply.
   Article 2
   Definitions
   For the purposes of this Directive the following definitions shall apply:

               (a)

               ‘conservation in situ’ means the conservation of genetic material in its natural surroundings and, in the case of cultivated plant species, in the farmed environment where they have developed their distinctive properties;

               (b)

               ‘genetic erosion’ means loss of genetic diversity between and within populations or varieties of the same species over time, or reduction of the genetic basis of a species due to human intervention or environmental change;

               (c)

               ‘landrace’ means a set of populations or clones of a plant species which are naturally adapted to the environmental conditions of their region;

               (d)

               ‘seed’ means seed and seed potatoes, unless seed potatoes are expressly excluded.

         CHAPTER II
   ACCEPTANCE OF CONSERVATION VARIETIES
   Article 3
   Conservation variety
   Member States may accept in the national catalogues of varieties of agricultural plant species the landraces and varieties referred to in Article 1(1)(a) subject to the requirements provided for in Articles 4 and 5. Such landraces or varieties shall be referred to in the common catalogue of varieties of agricultural plant species as ‘conservation varieties’.
   Article 4
   Substantive requirements
   1.   In order to be accepted as a conservation variety, a landrace or variety referred to in Article 1(1)(a) shall present an interest for the conservation of plant genetic resources.
   2.   By way of derogation from Article 1(2) of Directive 2003/90/EC, Member States may adopt their own provisions as regards distinctness, stability and uniformity of conservation varieties.
   In such cases Member States shall ensure that for distinctness and stability at least the characteristics shall apply which are referred to in:

               (a)

               the technical questionnaires associated with the test protocols of the Community Plant Variety Office (CPVO) listed in Annex I to Directive 2003/90/EC, which applies to those species, or

               (b)

               the technical questionnaires of the guidelines of the International Union for the Protection of New Varieties of Plants (UPOV) listed in Annex II to Directive 2003/90/EC, which applies to those species.

         For the assessment of uniformity, Directive 2003/90/EC shall apply.
   However, if the uniformity level is established on the basis of off-types, a population standard of 10 % and an acceptance probability of at least 90 % shall be applied.
   Article 5
   Procedural requirements
   By way of derogation from the first sentence of Article 7(1) of Directive 2002/53/EC, no official examination shall be required if the following information is sufficient for the decision on the acceptance of the conservation varieties:

               (a)

               the description of the conservation variety and its denomination;

               (b)

               the results of unofficial tests;

               (c)

               knowledge gained from practical experience during cultivation, reproduction and use, as notified by the applicant to the Member State concerned;

               (d)

               other information, in particular from the plant genetic resource authorities or from organisations recognised for this purpose by the Member States.

         Article 6
   Exclusion of acceptance
   A conservation variety shall not be accepted for inclusion in the national catalogues of varieties if:

               (a)

               it is already listed in the common catalogue of varieties of agricultural plant species as a variety other than a conservation variety, or it was deleted from the common catalogue within the last two years, or within the last two years from the expiry of the period granted under Article 15(2) of Directive 2002/53/EC, or

               (b)

               it is protected by a Community plant variety right as provided for in Council Regulation (EC) No 2100/94 (13), or by a national plant variety right, or an application for such a right is pending.

         Article 7
   Denomination
   1.   With respect to denominations of conservation varieties which were known before 25 May 2000, Member States may permit derogations from Regulation (EC) No 930/2000, except where such derogations would violate prior rights of a third party which is protected under Article 2 of that Regulation.
   2.   Notwithstanding Article 9(2) of Directive 2002/53/EC, Member States may accept more than one name for a variety if the names concerned are historically known.
   Article 8
   Region of origin
   1.   When a Member State accepts a conservation variety, it shall identify the region or regions in which the variety has historically been grown and to which it is naturally adapted, hereinafter ‘region of origin’. It shall take into account information from plant genetic resource authorities or from organisations recognised for that purpose by the Member States.
   Where the region of origin is located in more than one Member States, it shall be identified by all Member States concerned by common accord.
   2.   The Member State or Member States performing the identification of the region of origin shall notify the identified region to the Commission.
   Article 9
   Maintenance
   Member States shall ensure that a conservation variety must be maintained in its region of origin.
   CHAPTER III
   SEED PRODUCTION AND MARKETING
   Article 10
   Certification
   1.   By way of derogation from the certification requirements provided for in Article 3(1) of Directive 66/401/EEC, Article 3(1) of Directive 66/402/EEC, Article 3(1) of Directive 2002/54/EC, Article 3(1) of Directive 2002/56/EC and Article 3(1) of Directive 2002/57/EC, Member States may provide that seed of a conservation variety may be placed on the market if it complies with paragraphs 2, 3 and 4 of this Article.
   2.   The seed shall descend from seed produced according to well defined practices for maintenance of the variety.
   3.   The seed, except seed of Oryza sativa, shall comply with the requirements for certification of certified seed provided for in Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/56/EC and 2002/57/EC, with the exception of the requirements in respect of minimum varietal purity and the requirements concerning official examination or examination under official supervision.
   Seed of Oryza sativa shall comply with the requirements for certification of ‘certified seed, second generation’ provided for in Directive 66/402/EEC, with the exception of the requirements in respect of minimum varietal purity and the requirements concerning official examination or examination under official supervision.
   The seed shall have sufficient varietal purity.
   4.   As regards seed potatoes, Member States may provide that Article 10 of Directive 2002/56/EC concerning the size shall not apply.
   Article 11
   Region of seed production
   1.   Member States shall ensure that seed of a conservation variety may only be produced in the region of origin.
   If the conditions for certification provided for in Article 10(3) cannot be fulfilled in that region, due to a specific environmental problem, Member States may approve additional regions for seed production taking into account information from plant genetic resource authorities or from organisations recognised for this purpose by the Member States. However, seed produced in those additional regions may be used exclusively in the regions of origin.
   2.   Member States shall notify to the Commission and to the other Member States the additional regions which they intend to approve for seed production pursuant to paragraph 1.
   The Commission and the other Member States may, within 20 working days from receipt of those notifications, request the matter to be referred to the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry. A decision shall be taken in accordance with Article 22a(1)(b) of Directive 66/401/EEC, Article 22a(1)(b) of Directive 66/402/EEC, Article 4(6), Article 20(2) and Article 21 of Directive 2002/53/EC, Article 30(1)(b) of Directive 2002/54/EC, Article 10(1) and Article 27(1)(b) of Directive 2002/56/EC and Article 27(1)(b) of Directive 2002/57/EC, as appropriate,to lay down, if necessary, restrictions or conditions for the designation of such regions.
   If neither the Commission nor other Member States make a request under the second subparagraph, the Member State in question may approve the additional regions for seed production as notified.
   Article 12
   Seed testing
   1.   Member States shall ensure that tests are carried out to check that seed of conservation varieties complies with the certification requirements provided for in Article 10(3).
   Such tests shall be carried out in accordance with current international methods, or, where such methods do not exist, in accordance with any appropriate methods.
   2.   For the tests referred to in paragraph 1, Member States shall ensure that samples are drawn from homogeneous lots. They shall ensure that the rules on lot weight and sample weight provided for in Article 7(2) of Directive 66/401/EEC, Article 7(2) of Directive 66/402/EEC, Article 9(2) of Directive 2002/54/EC and Article 9(2) of Directive 2002/57/EC are applied.
   Article 13
   Marketing conditions
   1.   Member States shall ensure that seed of a conservation variety may only be marketed subject to the following conditions:

               (a)

               it has been produced in its region of origin or in a region referred to in Article 11;

               (b)

               marketing takes place in its region of origin.

         2.   By way of derogation from paragraph 1(b), a Member State may approve additional regions in its own territory for the marketing of seed of a conservation variety provided that those regions are comparable to the region of origin as regards the natural and semi-natural habitats of that variety.
   Where Member States approve such additional regions, they shall ensure that the amount of seed necessary for the production of at least the quantity of seed referred to in Article 14 is reserved to conserve the variety in its region of origin.
   The Member States shall inform the Commission and the other Member States of the approval of such additional regions.
   3.   Where a Member State approves additional regions for seed production in accordance with Article 11, it shall not use the derogation provided for in paragraph 2 of this Article.
   Article 14
   Quantitative restrictions
   Each Member State shall ensure that, for each conservation variety, the quantity of seed marketed does not exceed 0,5 % of the seed of the same species used in that Member State in one growing season, or a quantity necessary to sow 100 ha, whichever is the greater quantity. For the species Pisum sativum, Triticum spp., Hordeum vulgare, Zea mays, Solanum tuberosum, Brassica napus and Helianthus annuus, that percentage shall not exceed 0,3 %, or a quantity necessary to sow 100 ha, whichever is the greater quantity.
   However, the total quantity of seed of conservation varieties marketed in each Member State shall not exceed 10 % of the seed of the species concerned used yearly in the Member State. In cases where this leads to a quantity lower than necessary to sow 100 ha, the maximum amount of seed of the species concerned used yearly in the Member State may be increased so that to reach the quantity necessary to sow 100 ha.
   Article 15
   Application of quantitative restrictions
   1.   Member States shall ensure that producers notify them before the beginning of each production season of the size and the location of the area for the seed production.
   2.   If, based on the notifications referred to in paragraph 1, the quantities laid down in Article 14 are likely to be exceeded, Member States shall allocate to each producer concerned the quantity it may market in the respective production season.
   Article 16
   Monitoring of seed crops
   Member States shall ensure by official monitoring that the seed crops of a conservation variety comply with the provisions of this Directive, paying particular attention to the variety, locations of the seed production and quantities.
   Article 17
   Sealing of packages and containers
   1.   Member States shall ensure that seed of conservation varieties may be marketed only in closed packages or containers bearing a sealing device.
   2.   Seed packages and containers shall be sealed by the supplier in such a manner that they cannot be opened without damaging the sealing system or leaving evidence of tampering on the supplier’s label, or on the package or container.
   3.   In order to ensure sealing in accordance with paragraph 2, the sealing system shall comprise at least the label or the affixing of a seal.
   Article 18
   Labelling
   Member States shall ensure that packages or containers of seed of conservation varieties bear a supplier’s label or a printed or stamped notice including the following information:

               (a)

               the words ‘EC rules and standards’;

               (b)

               the name and address of the person responsible for affixing the labels or his identification mark;

               (c)

               the year of sealing expressed as: ‘sealed…’ (year), or, except for seed potatoes, the year of the last sampling for the purposes of the last testing of germination expressed as: ‘sampled…’ (year);

               (d)

               the species;

               (e)

               the denomination of the conservation variety;

               (f)

               the words ‘conservation variety’;

               (g)

               the region of origin;

               (h)

               where the region of seed production is different from the region of origin, the indication of the region of seed production;

               (i)

               the reference number of the lot given by the person responsible for affixing the labels;

               (j)

               the declared net or gross weight, or, except for seed potato, declared number of seeds;

               (k)

               where weight is indicated and granulated pesticides, pelleting substances or other solid additives are used, the nature of the chemical treatment or additive and the approximate ratio between the weight of clusters of pure seeds and the total weight, except for seed potatoes.

         Article 19
   Official post control
   The Member States shall ensure that seed is subject to official post control by random inspections to verify its varietal identity and varietal purity.
   CHAPTER IV
   GENERAL AND FINAL PROVISIONS
   Article 20
   Reporting
   The Member States shall ensure that suppliers operating in their territory report for each production season the amount of seed of each conservation variety placed on the market.
   The Member States shall report on request to the Commission and to the other Member States the amount of seed of each conservation variety placed on the market in their territory.
   Article 21
   Notification of the recognised organisations of plant genetic resources
   Member States shall notify to the Commission the recognised organisations referred to in Articles 5(d), 8(1) and 11(1).
   Article 22
   Evaluation
   By 31 December 2011 the Commission shall evaluate the implementation of Articles 4, 13(2), 14 and 15.
   Article 23
   Transposition
   1.   Member States shall bring into force, by 30 June 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 24
   Entry into force
   This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
   Article 25
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 20 June 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ 125, 11.7.1966, p. 2298/66. Directive as last amended by Commission Directive 2007/72/EC (OJ L 329, 14.12.2007, p. 37).

      (2)  OJ 125, 11.7.1966, p. 2309/66. Directive as last amended by Commission Directive 2006/55/EC (OJ L 159, 13.6.2006, p. 13).

      (3)  OJ L 193, 20.7.2002, p. 1. Directive as last amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 1).

      (4)  OJ L 193, 20.7.2002, p. 12. Directive as last amended by Directive 2004/117/EC (OJ L 14, 18.1.2005, p. 18).

      (5)  OJ L 193, 20.7.2002, p. 60. Directive as last amended by Commission Decision 2005/908/EC (OJ L 329, 16.12.2005, p. 37).

      (6)  OJ L 193, 20.7.2002, p. 74. Directive as last amended by Directive 2004/117/EC.

      (7)  OJ L 309, 13.12.1993, p. 1.

      (8)  OJ L 378, 23.12.2004, p. 1.

      (9)  OJ L 162, 30.4.2004, p. 18.

      (10)  OJ L 277, 21.10.2005, p. 1. Regulation as last amended by Regulation (EC) No 146/2008 (OJ L 46, 21.2.2008, p. 1).

      (11)  OJ L 254, 8.10.2003, p. 7. Directive as last amended by Directive 2007/48/EC (OJ L 195, 27.7.2007, p. 29).

      (12)  OJ L 108, 5.5.2000, p. 3. Regulation as last amended by Regulation (EC) No 920/2007 (OJ L 201, 2.8.2007, p. 3).

      (13)  OJ L 227, 1.9.1994, p. 1.


title: Commission Directive 2008/42/EC of 3 April 2008 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress (Text with EEA relevance)

text:
               4.4.2008

               EN

               Official Journal of the European Union

               L 93/13

      COMMISSION DIRECTIVE 2008/42/EC
   of 3 April 2008
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof,
   Whereas:

               (1)

               On the basis of the IFRA (International Fragrance Association) Code of Practice, the Scientific Committee on Consumer Products (SCCP) (2), identified substances used as fragrance compounds in cosmetic products for which some restrictions should be provided.

               (2)

               Considering that whatever the function of these substances in cosmetic products is, it is the exposure to these substances which should be considered. Therefore, the restrictions should not be limited to the use of the identified substances as fragrance compounds in cosmetic products.

               (3)

               However, sensitisation would not exist when the substance is used in oral products. Therefore, in order to ensure consistency, as some of these substances are authorised as flavouring substances by Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996 (3), these restrictions should not apply to substances listed under this register.

               (4)

               In the light of the opinions of the SCCP, it is necessary to amend the restrictions related to the identified substances which are already listed in Annex III to Directive 76/768/EEC under entries 45, 72, 73, 88 and 89. Furthermore, it is appropriate to include in that Annex those identified substances which are not yet listed with their respective restrictions, as well as, for consistency, substances belonging to the same family identified in Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products (4).

               (5)

               Benzyl alcohol being listed twice in Annex III part 1, under reference numbers 45 and 68, the content of entry 68 as well as the new restrictions should be included in entry 45.

               (6)

               Following clarification by the SCCP regarding Peru balsam, entry 1136 of Annex II should be amended.

               (7)

               Directive 76/768/EEC should therefore be amended accordingly.

               (8)

               In order to ensure a smooth progression from the existing formulae of cosmetic products to formulae which comply with the requirements laid down in this Directive, it is necessary to provide for appropriate transitional periods.

               (9)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes II and III of Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   Member States shall take all necessary measures to ensure that products which fail to comply with this Directive are not sold or disposed of to the final consumer after 4 October 2009.
   Article 3
   1.   Member States shall adopt and publish, by 4 October 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 4 April 2009.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 3 April 2008.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2008/14/EC (OJ L 42, 16.2.2008, p. 43).

      (2)  OJ L 66, 4.3.2004, p. 45. Decision as amended by Decision 2007/263/EC (OJ L 114, 1.5.2007, p. 14).

      (3)  OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision 2006/252/EC (OJ L 91, 29.3.2006, p. 48).

      (4)  OJ L 132, 1.6.1996, p. 1. Decision as amended by Decision 2006/257/EC (OJ L 97, 5.4.2006, p. 1).

      ANNEX
      Directive 76/768/EEC is amended as follows:

                  (1)

                  In Annex II, reference number 1136 is replaced by the following: ‘Exudation of Myroxylon pereirae (Royle) Klotzch (Peru balsam, crude); CAS No 8007-00-9) when used as fragrance ingredient’.

                  (2)

                  Part 1 of Annex III is amended as follows:

                              (a)

                              reference number 68 is deleted;

                              (b)

                              reference numbers 45, 72, 73, 88 and 89 are replaced by the following:

                                          Reference number

                                          Substance

                                          Restrictions

                                          Conditions of use and warnings which must be printed on the label

                                          Field of application and/or use

                                          Maximum authorised concentration in the finished cosmetic product

                                          Other limitations and requirements

                                          a

                                          b

                                          c

                                          d

                                          e

                                          f

                                          ‘45

                                          Benzyl alcohol (1)

                                          CAS No 100-51-6

                                                      (a)

                                                      Solvent

                                                      (b)

                                                      fragrance/aromatic compositions/their raw materials

                                          (b)
                                          The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

                                                      —

                                                      0,001 % in leave-on products

                                                      —

                                                      0,01 % in rinse-off products

                                          72

                                          Hydroxycitronellal
                                          CAS No 107-75-5

                                                      (a)

                                                      Oral products

                                          (a) (b)
                                          The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

                                                      —

                                                      0,001 % in leave-on products

                                                      —

                                                      0,01 % in rinse-off products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      1,0 %

                                          73

                                          Isoeugenol
                                          CAS No 97-54-1

                                                      (a)

                                                      Oral products

                                          (a) (b)
                                          The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

                                                      —

                                                      0,001 % in leave-on products

                                                      —

                                                      0,01 % in rinse-off products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,02 %

                                          88

                                             d-Limonene
                                          CAS No 5989-27-5

                                          The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

                                                      —

                                                      0,001 % in leave-on products

                                                      —

                                                      0,01 % in rinse-off products

                                                Peroxide value less than 20 mmoles/L (2)

                                          89

                                          Methyl 2-octynoate
                                          CAS No 111-12-6

                                                      (a)

                                                      Oral products

                                          (a) (b)
                                          The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

                                                      —

                                                      0,001 % in leave-on products

                                                      —

                                                      0,01 % in rinse-off products

                                          Methyl heptine carbonate

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,01 % when used alone
                                                      When present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)

                              (c)

                              The following reference numbers 103 to 184 are added:

                                          Reference number

                                          Substance

                                          Restrictions

                                          Conditions of use and warnings which must be printed on the label

                                          Field of application and/or use

                                          Maximum authorised concentration in the finished cosmetic product

                                          Other limitations and requirements

                                          a

                                          b

                                          c

                                          d

                                          e

                                          f

                                          ‘103

                                          Abies alba cone oil and extract
                                          CAS No 90028-76-5

                                          Peroxide value less than 10 mmoles/L (3)

                                          104

                                          Abies alba needle oil and extract
                                          CAS No 90028-76-5

                                          Peroxide value less than 10 mmoles/L (3)

                                          105

                                          Abies pectinata needle oil and extract
                                          CAS No 92128-34-2

                                          Peroxide value less than 10 mmoles/L (3)

                                          106

                                          Abies sibirica needle oil and extract
                                          CAS No 91697-89-1

                                          Peroxide value less than 10 mmoles/L (3)

                                          107

                                          Abies balsamea needle oil and extract
                                          CAS No 85085-34-3

                                          Peroxide value less than 10 mmoles/L (3)

                                          108

                                          Pinus mugo pumilio leaf and twig oil and extract
                                          CAS No 90082-73-8

                                          Peroxide value less than 10 mmoles/L (3)

                                          109

                                          Pinus mugo leaf and twig oil and extract
                                          CAS No 90082-72-7

                                          Peroxide value less than 10 mmoles/L (3)

                                          110

                                          Pinus sylvestris leaf and twig oil and extract
                                          CAS No 84012-35-1

                                          Peroxide value less than 10 mmoles/L (3)

                                          111

                                          Pinus nigra leaf and twig oil and extract
                                          CAS No 90082-74-9

                                          Peroxide value less than 10 mmoles/L (3)

                                          112

                                          Pinus palustris leaf and twig oil and extract
                                          CAS No 97435-14-8

                                          Peroxide value less than 10 mmoles/L (3)

                                          113

                                          Pinus pinaster leaf and twig oil and extract
                                          CAS No 90082-75-0

                                          Peroxide value less than 10 mmoles/L (3)

                                          114

                                          Pinus pumila leaf and twig oil and extract
                                          CAS No 97676-05-6

                                          Peroxide value less than 10 mmoles/L (3)

                                          115

                                          Pinus species leaf and twig oil and extract
                                          CAS No 94266-48-5

                                          Peroxide value less than 10 mmoles/L (3)

                                          116

                                          Pinus cembra leaf and twig oil and extract
                                          CAS No 92202-04-5

                                          Peroxide value less than 10 mmoles/L (3)

                                          117

                                          Pinus cembra leaf and twig extract acetylated
                                          CAS No 94334-26-6

                                          Peroxide value less than 10 mmoles/L (3)

                                          118

                                          Picea Mariana Leaf Oil and Extract
                                          CAS No 91722-19-9

                                          Peroxide value less than 10 mmoles/L (3)

                                          119

                                          Thuja Occidentalis Leaf Oil and Extract
                                          CAS No 90131-58-1

                                          Peroxide value less than 10 mmoles/L (3)

                                          120

                                          Thuja Occidentalis Stem Oil
                                          CAS No 90131-58-1

                                          Peroxide value less than 10 mmoles/L (3)

                                          121

                                          3-Carene
                                          CAS No 13466-78-9
                                          3,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene)

                                          Peroxide value less than 10 mmoles/L (3)

                                          122

                                          Cedrus atlantica wood oil and extract
                                          CAS No 92201-55-3

                                          Peroxide value less than 10 mmoles/L (3)

                                          123

                                          Cupressus sempervirens leaf oil and extract
                                          CAS No 84696-07-1

                                          Peroxide value less than 10 mmoles/L (3)

                                          124

                                          Turpentine gum (Pinus spp.)
                                          CAS No 9005-90-7

                                          Peroxide value less than 10 mmoles/L (3)

                                          125

                                          Turpentine oil and rectified oil
                                          CAS No 8006-64-2

                                          Peroxide value less than 10 mmoles/L (3)

                                          126

                                          Turpentine, steam distilled (Pinus spp.)
                                          CAS No 8006-64-2

                                          Peroxide value less than 10 mmoles/L (3)

                                          127

                                          Terpene alcohols acetates
                                          CAS No 69103-01-1

                                          Peroxide value less than 10 mmoles/L (3)

                                          128

                                          Terpene hydrocarbons
                                          CAS No 68956-56-9

                                          Peroxide value less than 10 mmoles/L (3)

                                          129

                                          Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1
                                          CAS No 65996-98-7

                                          Peroxide value less than 10 mmoles/L (3)

                                          130

                                          Terpene terpenoids sinpine
                                          CAS No 68917-63-5

                                          Peroxide value less than 10 mmoles/L (3)

                                          131

                                          α-Terpinene
                                          CAS No 99-86-5
                                          p-Mentha-1,3-diene

                                          Peroxide value less than 10 mmoles/L (3)

                                          132

                                          γ-Terpinene
                                          CAS No 99-85-4
                                          p-Mentha-1,4-diene

                                          Peroxide value less than 10 mmoles/L (3)

                                          133

                                          Terpinolene
                                          CAS No 586-62-9
                                          p-Mentha-1,4(8)-diene

                                          Peroxide value less than 10 mmoles/L (3)

                                          134

                                          Acetyl hexamethyl indan
                                          CAS No 15323-35-0

                                                      (a)

                                                      Leave-on products

                                                      (a)

                                                      2 %

                                          1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone

                                                      (b)

                                                      Rinse-off products

                                          135

                                          Allyl butyrate
                                          CAS No 2051-78-7
                                          2-Propenyl Butanoate

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          136

                                          Allyl cinnamate
                                          CAS No 1866-31-5
                                          2-Propenyl 3-Phenyl-2-propenoate

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          137

                                          Allyl cyclohexylacetate
                                          CAS No 4728-82-9
                                          2-Propenyl Cyclohexaneacetate

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          138

                                          Allyl cyclohexylpropionate
                                          CAS No 2705-87-5
                                          2-Propenyl 3-Cyclohexanepropanoate

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          139

                                          Allyl heptanoate
                                          CAS No 142-19-8
                                          2-Propenyl heptanoate

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          140

                                          Allyl caproate
                                          CAS No 123-68-2
                                          Allyl hexanoate

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          141

                                          Allyl isovalerate
                                          CAS No 2835-39-4
                                          2-Propenyl 3-Methyl-butanoate

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          142

                                          Allyl octanoate
                                          CAS No 4230-97-1
                                          2-Allyl caprylate

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          143

                                          Allyl phenoxyacetate
                                          CAS No 7493-74-5
                                          2-Propenyl Phenoxyacetate

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          144

                                          Allyl phenylacetate
                                          CAS No 1797-74-6
                                          2-Propenyl Benzeneacetate

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          145

                                          Allyl 3,5,5-trimethylhexanoate
                                          CAS No 71500-37-3

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          146

                                          Allyl cyclohexyloxyacetate
                                          CAS No 68901-15-5

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          147

                                          Allyl isoamyloxyacetate
                                          CAS No 67634-00-8

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          148

                                          Allyl 2-methylbutoxyacetate
                                          CAS No 67634-01-9

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          149

                                          Allyl nonanoate
                                          CAS No 7493-72-3

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          150

                                          Allyl propionate
                                          CAS No 2408-20-0

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          151

                                          Allyl trimethylhexanoate
                                          CAS No 68132-80-9

                                          Level of free allyl alcohol in the ester should be less than 0,1 %

                                          152

                                          Allyl heptine carbonate
                                          CAS No 73157-43-4
                                          (allyl oct-2-ynoate)

                                          0,002 %

                                          This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)

                                          153

                                          Amylcyclopentenone
                                          CAS No 25564-22-1
                                          2-Pentylcyclopent-2-en-1-one

                                          0,1 %

                                          154

                                             Myroxylon balsamum var pereirae. extracts and distillates

                                          CAS No 8007-00-9
                                          Balsam Peru oil, absolute and anhydrol
                                          (Balsam Oil Peru)

                                          0,4 %

                                          155

                                          4-tert.-Butyldihydrocinnamaldehyde
                                          CAS No 18127-01-0
                                          3-(4-tert-Butylphenyl)propion-aldehyde

                                          0,6 %

                                          156

                                          Cuminum cyminum fruit oil and extract
                                          CAS No 84775-51-9

                                                      (a)

                                                      Leave-on products

                                                      (b)

                                                      Rinse-off products

                                                      (a)

                                                      0,4 % of Cumin oil

                                          157

                                             cis-Rose ketone-1 (4)

                                          CAS No 23726-94-5

                                             (Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one
                                          (cis-α-Damascone)

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,02 %

                                          158

                                             trans-Rose ketone-2 (4)

                                          CAS No 23726-91-2

                                             (E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one
                                          (trans-β-Damascone)

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,02 %

                                          159

                                             trans-Rose ketone-5 (4)

                                          CAS No 39872-57-6

                                             (E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one
                                          (Isodamascone)

                                          0,02 %

                                          160

                                          Rose ketone-4 (4)

                                          CAS No 23696-85-7
                                          1-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone)

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,02 %

                                          161

                                          Rose ketone-3 (4)

                                          CAS No 57378-68-4
                                          1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one
                                          (Delta-Damascone)

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,02 %

                                          162

                                             cis-Rose ketone-2 (4)

                                          CAS No 23726-92-3
                                          1-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one
                                          (cis-β-Damascone)

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,02 %

                                          163

                                             trans-Rose ketone-1 (4)

                                          CAS No 24720-09-0
                                          1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one
                                          (trans-α-Damascone)

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,02 %

                                          164

                                          Rose ketone-5 (4)

                                          CAS No 33673-71-1
                                          1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one

                                                      (b)

                                                      0,02 %

                                          165

                                             trans-Rose ketone-3 (4)

                                          CAS No 71048-82-3
                                          1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one
                                          (trans-delta-Damascone)

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,02 %

                                          166

                                             trans-2-hexenal
                                          CAS No 6728-26-3

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,002 %

                                          167

                                             l-Limonene
                                          CAS No 5989-54-8
                                          (S)-p-Mentha-1,8-diene

                                          Peroxide value less than 20 mmoles/L (3)

                                          168

                                             dl-Limonene (racemic)
                                          CAS No 138-86-3
                                          1,8(9)-p-Menthadiene; p-Mentha-1,8-diene
                                          (Dipentene)

                                          Peroxide value less than 20 mmoles/L (3)

                                          169

                                          Perillaldehyde
                                          CAS No 2111-75-3
                                          p-Mentha-1,8-dien-7-al

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,1 %

                                          170

                                          Isobergamate
                                          CAS No 68683-20-5
                                          Menthadiene-7-methyl formate

                                          0,1 %

                                          171

                                          Methoxy dicyclopentadiene carboxaldehyde
                                          CAS No 86803-90-9
                                          Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde

                                          0,5 %

                                          172

                                          3-methylnon-2-enenitrile
                                          CAS No 53153-66-5

                                          0,2 %

                                          173

                                          Methyl octine carbonate
                                          CAS No 111-80-8
                                          Methyl non-2-ynoate

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,002 % when used alone
                                                      When present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)

                                          174

                                          Amylvinylcarbinyl acetate
                                          CAS No 2442-10-6
                                          1-Octen-3-yl acetate

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,3 %

                                          175

                                          Propylidenephthalide
                                          CAS No 17369-59-4
                                          3-Propylidenephthalide

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,01 %

                                          176

                                          Isocyclogeraniol
                                          CAS No 68527-77-5
                                          2,4,6-Trimethyl-3-cyclohexene-1-methanol

                                          0,5 %

                                          177

                                          2-Hexylidene cyclopentanone
                                          CAS No 17373-89-6

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,06 %

                                          178

                                          Methyl heptadienone
                                          CAS No 1604-28-0
                                          6-Methyl-3,5-heptadien-2-one

                                                      (a)

                                                      Oral products

                                                      (b)

                                                      Other products

                                                      (b)

                                                      0,002 %

                                          179

                                          p-methylhydrocinnamic aldehyde
                                          CAS No 5406-12-2
                                          Cresylpropionalde-hyde

                                             p-Methyldihydrocinnamaldehyde

                                          0,2 %

                                          180

                                          Liquidambar orientalis Balsam oil and extract
                                          CAS No 94891-27-7
                                          (styrax)

                                          0,6 %

                                          181

                                          Liquidambar styraciflua balsam oil and extract
                                          CAS No 8046-19-3
                                          (styrax)

                                          0,6 %

                                          182

                                          Acetyl hexamethyl tetralin
                                          CAS No 21145-77-7
                                          CAS No 1506-02-1
                                          1-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
                                          (AHTN)

                                          All cosmetic products, with the exception of oral products

                                                      (a)

                                                      leave-on products: 0,1 %
                                                      except:
                                                      hydro
                                                      alcoholic products: 1 %
                                                      fine fragrance: 2,5 %
                                                      fragrance cream:
                                                      0,5 %

                                                      (b)

                                                      rinse-off products: 0,2 %

                                          183

                                             Commiphora erythrea engler var. glabrescens engler gum extract and oil
                                          CAS No 93686-00-1

                                          0,6 %

                                          184

                                          Opopanax chironium resin
                                          CAS No 93384-32-8

                                          0,6 %

         (1)  As a preservative, see Annex VI, Part 1, No 34.

         (2)  This limit applies to the substance and not to the finished cosmetic product.’

         (3)  This limit applies to the substance and not to the finished cosmetic product.

         (4)  The sum of those substances used in combination should not exceed the limits given in column d.’