title: 2009/543/EC: Commission Decision of 13 August 2008 establishing the ecological criteria for the award of the Community eco-label to outdoor paints and varnishes (notified under document number C(2008) 4452) (Text with EEA relevance)

text:
               14.7.2009

               EN

               Official Journal of the European Union

               L 181/27

      COMMISSION DECISION

   of 13 August 2008
   establishing the ecological criteria for the award of the Community eco-label to outdoor paints and varnishes
   (notified under document number C(2008) 4452)
   (Text with EEA relevance)
   (2009/543/EC)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme (1), and in particular the second subparagraph of Article 6(1) thereof,
   Whereas:

               (1)

               Under Regulation (EC) No 1980/2000 the Community eco-label may be awarded to a product possessing characteristics which enable it to contribute significantly to improvements in relation to key environmental aspects.

               (2)

               Regulation (EC) No 1980/2000 provides that specific eco-label criteria are to be established according to product groups.

               (3)

               It is appropriate to adopt a new decision establishing ecological criteria for the award of the Community eco-label to outdoor paints and vanishes.

               (4)

               The ecological criteria, as well as the related assessment and verification requirements, should be valid for a period of four years.

               (5)

               The measures provided for in this Decision are based on the draft criteria developed by the European Union Ecolabelling Board established under Article 13 of Regulation (EC) No 1980/2000.

               (6)

               The measures provided for in this Decision are in accordance with the opinion of the committee instituted by Article 17 of Regulation (EC) No 1980/2000,

         HAS ADOPTED THIS DECISION:
   Article 1
   1.   The product group ‘outdoor paints and varnishes’ shall comprise outdoor decorative and protective paints and varnishes, woodstains and related products for use on buildings and outdoor furniture, floors and fencing in accordance with paragraph 2, for use by do-it-yourself and professional users; and that are primarily developed for outdoor use and marketed as such.
   This includes, inter alia, floor coatings and floor paints; products which are tinted by distributors at the request of amateur or professional decorators; tinting systems; decorative paints in liquid or paste formulas which may have been pre-conditioned, tinted or prepared by the manufacturer to meet consumers needs, including wood paints, wood and decking stains, masonry coatings and metal finishes (excluding anti-corrosion finishes and primers) as well as primers (and undercoats) of such product systems.
   2.   ‘Paint’ means a pigmented coating material, in liquid or in paste or powder form, which when applied to a substrate, forms an opaque film having protective, decorative or specific technical properties.
   ‘Varnish’ means a clear coating material which when applied to a substrate forms a solid transparent film having protective, decorative or specific technical properties.
   After application, the paint or varnish dries to a solid, adherent and protective coating.
   Decorative paints and varnishes are paints and varnishes that are applied to buildings, their trim and fittings, as well as outdoor furniture, floors and fencing for decorative and protective purposes. They are applied in situ. Their function is decorative whilst providing a protective role.
   Woodstains (lasures) are coatings producing a transparent or semi-transparent film for decoration and protection of wood against weathering, which enables maintenance to be carried out easily.
   Masonry coatings are coatings that produce a decorative and protective film for use on concrete, (paintable) brickwork, blockwork, rendering, calcium silicate or fibre-reinforced cement. They are intended principally for exterior use, but may also be used internally, or on soffits and balcony ceilings.
   ‘Tinting systems’ is a method of preparing coloured paints by mixing a ‘base’ with coloured tints.
   3.   The following products are not included in the product group:

               (a)

               anti-corrosion coatings;

               (b)

               anti-fouling coatings;

               (c)

               wood preservation products;

               (d)

               coatings for particular industrial and professional uses, including heavy-duty coatings;

               (e)

               any product primarily developed for indoor use and marketed as such.

         Article 2
   1.   In order to be awarded the Community eco-label under Regulation (EC) No 1980/2000 and subject to paragraphs 2 and 3 of this Article, paints and varnishes must fall within the product group ‘outdoor paints and varnishes’ as defined in Article 1, and must comply with the ecological criteria set out in the Annex to this Decision.
   2.   Two-pack reactive performance coatings for specific end uses shall comply with the following conditions:

               (a)

               both components thereof must individually comply with the ecological criteria set out in the Annex (with the exception of the criterion for Volatile Organic Compounds);

               (b)

               they must be accompanied by information explaining that the individual components must not be used separately or mixed with other products;

               (c)

               the final ready-for-use product, however, must also meet the ecological criteria, including the criterion for VOC.

         3.   Coatings marketed for both indoor and outdoor use must satisfy both the criteria set out in this Decision for outdoor paints and varnishes and the criteria set out in Commission Decision 2009/544/EC (2) for indoor paints and varnishes.
   Article 3
   The ecological criteria for the product group ‘outdoor paints and varnishes’, as well as the related assessment and verification requirements, shall be valid four years as from the date of entry into force of this Decision.
   Article 4
   For administrative purposes the code number assigned to the product group ‘outdoor paints and varnishes’ shall be ‘33’.
   Article 5
   This Decision is addressed to the Member States.

      Done at Brussels, 13 August 2008.

            For the Commission

         Olli REHN

            Member of the Commission

      (1)  OJ L 237, 21.9.2000, p. 1.

      (2)  See page 39 of this Official Journal.

      ANNEX
      A.   FRAMEWORK

         The aims of the criteria

      These criteria aim in particular at:

                  —

                  the efficient use of the product and the minimisation of waste,

                  —

                  reducing the environmental and other risks (such as tropospheric ozone) by reducing solvent emissions,

                  —

                  reducing the discharges of toxic or otherwise polluting substances into waters. The criteria are set at levels that promote the labelling of exterior paints and varnishes which have a lower environmental impact.

         Assessment and verification requirements

      The specific assessment and verification requirements are indicated within each criterion.
      Where the applicant is required to provide declarations, documentation, analyses, test reports, or other evidence to show compliance with the criteria, it is understood that these may originate from the applicant and/or his supplier(s) and/or their supplier(s), etc. as appropriate.
      Where appropriate, test methods other than those indicated for each criterion may be used if their equivalence is accepted by the competent body assessing the application.
      Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications.
      The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or EN ISO14001, when assessing applications and monitoring compliance with the criteria (Note: it is not required to implement such management schemes).
      Where ingredients are referred to in the criteria, this includes substances and preparations. The definitions of ‘substances’ and ‘preparations’ are given in the REACH Regulation (Regulation (EC) No 1907/2006 of the European Parliament and of the Council (1).
      The exact formulation of the product should be provided to the competent body for all ingoing substances that are used by the applicant. Any substance, including impurities, present in concentrations greater than 0,01 % (m/m) should be reported unless a lower concentration is specified elsewhere in the criteria.
      B.   ECOLOGICAL CRITERIA

      All criteria except criterion 3 concerning VOC limits shall apply to the paint or varnish in its packaging. In line with the Directive 2004/42/EC of the European Parliament and of the Council (2) the VOC limits relate to the ready-to-use product and so the maximum VOC content should be calculated based on any recommended additions such as colourants and/or thinners. For this calculation, data supplied by the raw material suppliers regarding solids content, VOC content and product density will be required.
      Criteria 1 and 2 apply only to white paints and light coloured paints, (including finishes, primers, undercoats and/or intermediates).
      For tinting systems, criteria 1 and 2 apply only to the white (the base containing the most TiO2). In cases where the white base is unable to achieve the requirement of at least 6 m2 per litre at a hiding power of 98 % according to criterion 7(a), the criteria shall be met after tinting to produce the standard colour RAL 9010.
      Criteria 1 and 2 do not apply to transparent coatings.
      1.   White pigments

         White pigment content (white inorganic pigments with a refractive index higher than 1,8): Paints shall have a white pigment content lower or equal to 38 g per m2 of dry film, with 98 % opacity. This requirement does not apply to varnishes and woodstains.

         Assessment and verification: The applicant shall either provide a declaration of non-use or provide the content of white pigments and the spreading rate, together with the detailed calculation showing compliance with this criterion.
      2.   Titanium dioxide

         Titanium dioxide: The emissions and discharges of wastes from the production of any titanium dioxide pigment used shall not exceed the following (as derived from the Reference Document on Best Available Technology for the Manufacture of Large Volume Inorganic Chemicals (BREF) (August 2007)):

                  —

                  SOx emissions (expressed as SO2): 266 mg per m2 of dry film (98 % opacity),

                  —

                  sulphate wastes: 19 g per m2 of dry film (98 % opacity),

                  —

                  chloride wastes: 3,9, 6,8 and 12,5 g per m2 of dry film (98 % opacity) respectively for natural rutile, synthetic rutile and slag ores.

         Assessment and verification: The applicant shall either provide a declaration of non-use or provide the supporting documentation indicating the respective levels of emissions and discharges of wastes for these parameters, the titanium dioxide content of the product, the spreading rate, together with the detailed calculations showing compliance with this criterion.
      3.   Volatile organic compounds (VOC)

         VOC content shall not exceed:

                  Product Classification (Directive 2004/42/EC)

                  VOC limits (g/l including water)

                  Coatings for exterior walls of mineral substrate

                  40

                  Exterior trim and cladding paints for wood and metal including undercoats

                  90

                  Exterior trim varnishes and wood-stains, including opaque woodstains

                  90

                  Exterior minimum build woodstains

                  75

                  Primers (for exterior use)

                  15

                  Binding Primers (for exterior use)

                  15

                  1 Pack performance coatings

                  100

                  Two-pack reactive performance coatings for specific end use such as floors

                  100

            In this context volatile organic compounds (VOC) means any organic compounds having an initial boiling point less than or equal to 250 °C measured at a standard pressure of 101,3 kPa as defined Directive 2004/42/EC. The subcategories for paints and varnishes of the Directive are used for defining VOC limits. Only the categories relevant to outdoor coatings are displayed here.

         Assessment and verification: The applicant shall provide a declaration of compliance with this criterion. For all products the applicant shall indicate the VOC content.
      4.   Volatile aromatic hydrocarbons (VAH)

      Volatile aromatic hydrocarbons shall not be directly added to the product before or during tinting (where applicable); however ingredients containing VAH may be added up to such a limit that the VAH content in the end product will not exceed 0,1 % (m/m).
      In this context volatile aromatic hydrocarbon (VAH) means any organic compound, as defined in Directive 2004/42/EC, having an initial boiling point less than or equal to 250 °C measured at a standard pressure of 101,3kPa and having at least one aromatic nucleus in its developed structural formula.

         Assessment and verification: The applicant shall provide a declaration of compliance with this criterion stating that VAH has not been added other than in prefabricated ingredients and where applicable declarations from the suppliers of the ingredient confirming their VAH content.
      5.   Heavy metals

      The following heavy metals or their compounds shall not be used as an ingredient of the product or tint (as applicable) (whether as a substance or as part of any preparation used): cadmium, lead, chromium VI, mercury, arsenic, barium (excluding barium sulphate), selenium, antimony.
      Cobalt shall also not be added as an ingredient with the exception of cobalt salts used as a siccative in alkyd paints. These may be used up to a concentration not exceeding 0,05 % (m/m) in the end product, measured as cobalt metal. Cobalt in pigments is also exempted from this requirement.
      It is accepted that ingredients may contain traces of these metals up to 0,01 % (m/m) deriving from impurities in the raw materials.

         Assessment and verification: The applicant shall provide a declaration of compliance with this criterion as well as declarations from ingredient suppliers (where applicable).
      6.   Dangerous substances

                  (a)

                     The product: The product shall not be classified as very toxic, toxic, dangerous to the environment, carcinogenic, toxic for reproduction, harmful, corrosive, mutagenic or irritant (only where this is caused by the presence of ingredients labelled with R43) in accordance with Directive 1999/45/EC of the European Parliament and of the Council (3) before or after tinting (where applicable).

                     Assessment and verification: The applicant shall provide a declaration of compliance with this criterion, together with a product material safety data sheet meeting the requirements of Annex II to REACH Regulation.

                  (b)

                     Ingredients (very toxic, toxic, carcinogenic, mutagenic, toxic for reproduction): No ingredient including those used in tinting (if applicable) shall be used that is assigned or may be assigned at the time of application any of the following risk phrases (or combinations thereof):

                              —

                              R23 (toxic by inhalation),

                              —

                              R24 (toxic in contact with skin),

                              —

                              R25 (toxic if swallowed),

                              —

                              R26 (very toxic by inhalation),

                              —

                              R27 (very toxic in contact with skin),

                              —

                              R28 (very toxic if swallowed),

                              —

                              R33 (danger of cumulative effects),

                              —

                              R39 (danger of very serious irreversible effects),

                              —

                              R40 (limited evidence of carcinogenic effect),

                              —

                              R42 (may cause sensitisation by inhalation),

                              —

                              R45 (may cause cancer),

                              —

                              R46 (may cause heritable genetic damage),

                              —

                              R48 (danger of serious damage to health by prolonged exposure),

                              —

                              R49 (may cause cancer by inhalation),

                              —

                              R60 (may impair fertility),

                              —

                              R61 (may cause harm to the unborn child),

                              —

                              R62 (possible risk of impaired fertility),

                              —

                              R63 (possible risk of harm to the unborn child),

                              —

                              R68 (possible risk of irreversible effects),

                        as laid down in Council Directive 67/548/EEC (4), and its subsequent amendments. Active ingredients used as preservatives in the formula and that are assigned any of the risk phrases R23, R24, R25, R26, R27, R28, R39 R40 or R48 (or combinations thereof) may nevertheless be used up to a limit of 0,1 % (m/m) of the total paint formulation.
                  Alternatively, the Globally Harmonised System (GHS) of classification may be considered (5). In this case the ingredients, including those used in tinting (if applicable), classified as the following (or combinations thereof) shall not be used:

                              —

                              Acute Toxicity (oral) — Category I, II, III,

                              —

                              Acute Toxicity (dermal) — Category I, II, III,

                              —

                              Acute Toxicity (inhalation) — Category I, II, III,

                              —

                              Respiratory Sensitisation — Category I,

                              —

                              Mutagenic Substances — Category I, II,

                              —

                              Carcinogenic Substances — Category I, II,

                              —

                              Substances Toxic for Reproduction — Category I, II,

                              —

                              Specific Target Organ Systemic Toxicity (single exposure) — Category I, II,

                              —

                              Specific Target Organ Systemic Toxicity (repeated exposure) — Category I, II,

                        as laid down in ST/SG/AC.10/30 (6) and revised in ST/SG/AC.10/34/Add.3 on the Globally Harmonised System of Classification and Labelling of Chemicals. Active ingredients used as preservers in the formula and that are assigned any of the following GHS categories may nevertheless be used up to a limit of 0,1 % (m/m) of the total paint formulation:

                              —

                              Acute Toxicity (oral, dermal, inhalation) — I, II, III (only oral and dermal),

                              —

                              Specific Target Organ Systemic Toxicity (single and/or repeated exposure) — I, II (or combinations thereof) and,

                              —

                              Carcinogenicity category II.

                        Methyl Ethyl Ketoxime may be used in alkyd paints up to a limit of 0,3 % (m/m).

                     Assessment and verification: The applicant shall provide a declaration of compliance with this criterion, together with a product material safety data sheet meeting the requirements of Annex II to REACH Regulation.

                  (c)

                     Ingredients (dangerous for the environment): No ingredient shall exceed 2 % (m/m), including those used in tinting (if applicable), that is assigned or may be assigned at the time of application any of the following risk phrases:

                              —

                              N R50 (very toxic to aquatic organisms),

                              —

                              N R50/53 (very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment),

                              —

                              N R51/53 (toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment),

                              —

                              N R52/53 (harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment),

                              —

                              R51 (toxic to aquatic organisms),

                              —

                              R52 (harmful to aquatic organisms),

                              —

                              R53 (may cause long-term adverse effects in the aquatic environment),

                        as laid down in Directive 67/548/EEC or Directive 1999/45/EC.
                  Alternatively, the Globally Harmonised System (GHS) of classification may be considered (7). In this case no ingredient shall exceed 2 % (m/m), including those used in tinting (if applicable), that is assigned or may be assigned at the time of application any of the following classifications:
                  Aquatic Toxicity categories (and combinations thereof):

                              —

                              Acute I, II, III,

                              —

                              Chronic I, II, III, IV,

                        as laid down in ST/SG/AC.10/30 and revised in ST/SG/AC.10/34/Add.3 on the Globally Harmonised System of Classification and Labelling of Chemicals.
                  In either case, the sum total of all ingredients that are assigned or may be assigned at the time of application any of these risk phrases (or combinations thereof) or GHS classifications shall not exceed 4 % (m/m).
                  This requirement does not apply to ammonia or akyl ammonia.
                  This requirement does not affect the obligation to fulfil the requirement set out in criterion 6(a) above.

                     Assessment and verification: The applicant shall provide a declaration of compliance with this criterion, together with a list of ingredients and material safety data sheets of each ingredient meeting the requirements of Annex II to REACH Regulation.

                  (d)

                     Alkylphenolethoxylates (APEOs): APEOS shall not be used in the product before or during tinting (if applicable).

                     Assessment and verification: The applicant shall provide a declaration of compliance with this criterion.

                  (e)

                     Isothiazolinone compounds: The content of isothiazolinone compounds in the product shall not exceed 0,05 % (m/m) before or after tinting (if applicable). For wood coatings isothiazolinone compounds shall not exceed 0,2 % (m/m). Likewise the content of the mixture of 5-chloro-2-methyl-2H-isothiazol-3-one (EC No 247-500-7) and 2- methyl-2H-isothiazol-3-one (EC No 220-239-6) (3:1) shall not exceed 0,0015 % (m/m).

                     Assessment and verification: The applicant shall provide a declaration of compliance with this criterion, indicating the amounts (if used).

                  (f)

                  Perfluorinated alkyl sulfonates (PFAS), perfluorinated carboxylic acids (PFCA) including Perfluorooctanoic Acid (PFOA) and related substances listed in the OECD ‘Preliminary lists of PFOS, PFAS, PFOA, PFCA, related compounds and chemicals that may degrade to PFCA (as revised in 2007)’ are not permitted in the product. The OECD list is provided in the Annex to this criteria document.

                     Assessment and verification: The applicant shall provide a declaration of compliance with this criterion.

                  (g)

                     Formaldehyde: Free formaldehydes shall not be added. Formaldehyde donators may only be added in such quantities as will ensure that the resulting total content after tinting (if applicable) of free formaldehyde will not exceed 0,001 % (m/m).

                     Assessment and verification: The applicant shall provide a declaration of compliance with this criterion. In addition the applicant shall provide test results from raw materials suppliers using the VdL-RL 03 test method (VdL Guide-line03) ‘In-can concentration of formaldehyde determined by the acetyl-acetone method’ and calculations relating the data from these tests to the final product in order to indicate that the final maximum possible concentration of formaldehyde released by formaldehyde releasing substances is not higher than 0,001 % (m/m). Alternatively, formaldehyde resulting from formaldehyde donors can be measured in the end product based on High-performance liquid chromatography, by using a national standard or validated method as described in ISO/IEC 17025.

                  (h)

                     Halogenated Organic Solvents: Notwithstanding criteria 6a, 6b and 6c, only halogenated compounds that at the time of application have been risk assessed and have not been classified with the risk phrases (or combinations thereof): R26/27, R45, R48/20/22, R50, R51, R52, R53, R50/53, R51/53, R52/53 and R59 in accordance with Directives 67/548/EEC and 1999/45/EC may be used in the product before or during tinting (if applicable).

                     Assessment and verification: The applicant shall provide a declaration of compliance with this criterion.

                  (i)

                     Phthalates: Notwithstanding criteria 6a, 6b and 6c, only phthalates that at the time of application have been risk assessed and have not been classified with the phrases (or combinations thereof): R60, R61, R62, R50, R51, R52, R53, R50/53, R51/53, R52/53, in accordance with Directive 67/548/EEC and its amendments, may be used in the product before or during tinting (if applicable). Additionally DNOP (di-n-octyl phthalate), DINP (di-isononyl phthalate), DIDP (di-isodecyl phthalate) are not permitted in the product.

                     Assessment and verification: The applicant shall provide a declaration of compliance with this criterion.

            7.   Fitness for use

                  (a)

                     Spreading rate: White paints and light-coloured paints (including finishes, primers, undercoats and/or intermediates) shall have a spreading rate (at a hiding power of 98 %) of at least 6 m2 per litre of product.
                  For tinting systems, this criterion applies only to the white base (the base containing the most TiO2). In case the white base is unable to achieve the requirement of at least 6 m2 per litre at a hiding power of 98 %, the criterion shall be met after tinting the white base to produce the standard colour RAL 9010. For all other bases used to produce tinted products — these are bases which as a rule contain less TiO2, which are unable to achieve the requirement of at least 6 m2 per litre of product at a hiding power of 98 % — the criterion shall not apply. For paints that are a part of a tinting system, the applicant must advise the end-user on the product packaging and/or POS which shade or primer/undercoat (if possible carrying the European Eco-label) should be used as a basecoat before applying the darker shade.
                  Primers with specific blocking/sealing, penetrating/binding properties and primers with special adhesion properties for aluminium and galvanised surfaces shall have a spreading rate (at a hiding power of 98 %) of at least 6 m2 per litre of product.
                  Elastomeric paints shall have a spreading rate (at a hiding power of 98 %) of at least 4 m2 per litre of product.
                  This requirement does not apply to varnishes, woodstains, floor coatings, floor paints, undercoats, other adhesion primers or any other transparent coatings.

                     Assessment and verification: The applicant shall provide a test report using the method ISO6504/1 (Paints and varnishes — determination of hiding power — Part 1: Kubelka-Munk method for white and light-coloured paints) or 6504/3 (Part 3: determination of contrast ratio (opacity) of light-coloured paints at a fixed spreading rate), or (for paints specially designed to give a three-dimensional decorative effect and characterised by a very thick coat) the method NF T 30 073 (or equivalent). For bases used to produce tinted products not evaluated according to the abovementioned requirements, the applicant shall produce evidence that the end-user is advised to use a primer and/or grey (or other relevant shade) of undercoat before application of the product.

                  (b)

                     Resistance to water: Varnishes, floor coatings and floor paints shall have a resistance to water, as determined by ISO 2812-3 such that after 24 hours' exposure and 16 hours' recovery no change of gloss or of colour occurs.

                     Assessment and verification: The applicant shall provide a test report using the method ISO 2812-3 (Paints and varnishes — determination of resistance to liquids — Part 3: Method using an absorbent medium).

                  (c)

                     Adhesion: Masonry paints (excluding transparent primers) shall score a pass in the EN 24624 (ISO 4624) pull-off test for adhesion and floor coatings, floor paints and undercoats for concrete, wood and metal coatings shall score at least a 2 in the EN 2409 cross-cut method for adhesion. When carrying out EN 24624 where the cohesive strength of the substrate is less than the adhesive strength of the paint then this is considered a pass, otherwise the adhesion of the paint must be in excess of a pass value of 1,5MPa.
                  The applicant shall evaluate the primer and/or finish alone or both as part of a system (the system when tested shall concern products if possible labelled with the European Eco-label (with the exception of systems designed for metal surfaces)). When testing the finish alone this shall be considered the worst case scenario concerning adhesion.

                     Assessment and verification: The applicant shall provide a test report using the method EN ISO 2409 or EN 24624 (ISO 4624) as applicable.

                  (d)

                     Abrasion: Floor coatings and floor paints shall have an abrasion resistance not exceeding 70 mg weight loss after 1 000 test cycles with a 1 000 g load and a CS10 wheel according to EN ISO 7784-2:2006.

                     Assessment and verification: The applicant shall provide a test report showing compliance with this criterion using the method EN ISO 7784-2:2006.

                  (e)

                     Weathering: Masonry finish paints and wood and metal finishes including varnishes shall be exposed to artificial weathering in apparatus including fluorescent UV lamps and condensation or water spray according to 11507:2007. Masonry paints shall be exposed to test conditions for 1 000 hours, wood and metal finishes (including varnishes) shall be exposed to test conditions for 500 hours. Test conditions are: UVA 4h/60degC + humidity 4h/50degC.
                  Alternatively, wood finishes and wood varnishes may be exposed to weathering for 500 hours in the QUV accelerated weathering apparatus with cyclic exposure with UV(A) radiation and spraying according to EN 927-6.
                  The colour change of samples exposed to weathering shall not be greater than ΔΕ * = 4 and decrease in gloss for varnishes shall not be greater than 30 % of its initial value. The gloss shall be measured using ISO 2813. The criterion for colour change is not applicable to transparent varnishes and bases.
                  Chalking shall be tested using method EN ISO 4628-6:2007 on masonry finish coats and wood and metal finishes (where applicable) after the samples have been exposed to weathering. Coatings shall achieve a score of 1,5 or better (0,5 or 1,0) in this test. In the standard there are illustrated references.
                  The following parameters shall also be evaluated on masonry finish coats and wood and metal finishes after the samples have been exposed to weathering:

                              —

                              Flaking according to ISO 4628-5:2003; flake density 2 or less, flake size 2 or less,

                              —

                              Cracking according to ISO 4628-4:2003; crack quantity 2 or less, crack size 3 or less,

                              —

                              Blistering according to ISO 4628-2:2003; blister density 3 or less, blister size 3 or less.

                        Due to the large number of possible tinting colours, these tests will be restricted to the base paint used.

                     Assessment and verification: The applicant shall provide test reports using either ISO11507:2007 according to the specified parameters or EN 927-6, or both (if relevant). Additionally the applicant shall provide test reports using EN ISO 4628-2, 4, 5, 6 where applicable. The applicant shall also provide a declaration that (where applicable) the colour change of the coating is within the parameter set in this document.

                  (f)

                     Water vapour permeability: Where claims are made that exterior masonry and concrete paints are breathable the paint shall be classified as Class II (medium vapour permeability) or better according to the test method EN ISO 7783-2. Due to the large number of potential tinting colours, this criterion will be restricted to testing of the base paint; this requirement is not applicable to transparent primers.

                     Assessment and verification: The applicant shall provide a test report using methodology EN ISO 7783-2.

                  (g)

                     Liquid water permeability: Where claims are made that exterior masonry and concrete paints are water repellent or elastomeric, the coating shall be classified as Class III (low liquid permeability) according to method DIN EN 1062-3:1999. Due to the large number of potential tinting colours, this criterion will be restricted to the testing of the base paint. All other masonry paints shall be classified as Class II (medium liquid permeability) or better according to the test method DIN EN 1062-3:1999.

                     Assessment and verification: The applicant shall provide a test report using methodology DIN EN 1062-3:1999.

                  (h)

                     Fungal resistance: Where claims are made that masonry finish coatings have anti-fungal properties, the coating shall have a score of 2 or better (less than 10 % fungal coverage), as determined by method BS 3900:G6. Due to the large number of possible tinting colours, this criterion will be restricted to the testing of the base paint.

                     Assessment and verification: The applicant shall provide a test report using methodology BS 3900:G6.

                  (i)

                     Crack bridging: Where claims are made that masonry (or concrete) paint has elastomeric properties, it shall be at least classified as A1 at 23 °C according to DIN EN 1062-7:2004. Due to the large number of potential tinting colours, this criterion will be restricted to the testing of the base paint.

                     Assessment and verification: The applicant shall provide a test report using methodology DIN EN 1062-7:2004.

                  (j)

                     Alkali resistance: Masonry paints and primers shall show no noticeable damage when the coating is spotted for 24 hours with 10 % NaOH solution according to method ISO 2812-4:2007.The evaluation is done after 24 hours drying-recovery.

                     Assessment and verification: The applicant shall provide a test report using methodology ISO 2812-4:2007.

            8.   Consumer information

      The following information shall appear on the packaging or attached to the packaging:

                  —

                  the use, substrate and conditions of use for which the product is intended. This shall include advice on preparatory work, etc., such as correct substrate preparation, advice on outdoor use (where appropriate), or temperature,

                  —

                  recommendations for cleaning tools and appropriate waste management (in order to limit water pollution). These recommendations shall be adapted to the type of product in question and field of application in question and may make use of pictograms if appropriate,

                  —

                  recommendations concerning product storage conditions after opening (in order to limit solid waste), including safety advice if appropriate,

                  —

                  for darker coatings for which criterion 7(a) does not apply, advice is given concerning the use of the correct primer or base paint (if possible carrying the European Ecolabel),

                  —

                  text advising that unused paint requires specialist handling for safe environmental disposal and that it should not therefore be thrown away with household refuse or poured away. Advice regarding disposal and collection should be sought from the local authority,

                  —

                  recommendations on preventive protection measures for the painter. The following text (or equivalent text): shall appear on the packaging or attached to the packaging:
                  For more information as to why this product has been awarded the Flower please visit the web-site: http://ec.europa.eu/environment/ecolabel.

         Assessment and verification: A sample of the product packaging shall be provided on application, together with a corresponding declaration of compliance with these criteria, as appropriate.
      9.   Information appearing on the eco-label

      Box 2 of the eco-label shall contain the following text:

                  —

                  good performance for outdoor use,

                  —

                  hazardous substances restricted,

                  —

                  low solvent content.

         Assessment and verification: The applicant shall provide a sample of the product packaging showing the label, together with a declaration of compliance with this criterion.

         (1)  OJ L 396, 30.12.2006, p. 1.

         (2)  OJ L 143, 30.4.2004, p. 87.

         (3)  OJ L 200, 30.7.1999, p. 1.

         (4)  OJ 196, 16.8.1967, p. 1.

         (5)  On 27 June 2007, the European Commission adopted the ‘Proposal for a Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006’ (COM(2007) 355 final). For further information relating to the overlap between the existing system and GHS refer to Annex VII to Volume III of the proposal that has been adopted: http://ec.europa.eu/enterprise/reach/docs/ghs/ghs_prop_vol_iii_en.pdf

         (6)  United Nations Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonised System of Classification and Labelling of Chemicals: http://www.unece.org/trans/main/dgdb/dgcomm/ac10rep.html

         (7)  See footnote 5.


title: Council Decision 2005/426/CFSP of 6 June 2005 concerning the implementation of Common Position 2004/694/CFSP on further measures in support of the effective implementation of the mandate of the International Criminal Tribunal for the former Yugoslavia (ICTY)

text:
               8.6.2005

               EN

               Official Journal of the European Union

               L 144/52

      COUNCIL DECISION 2005/426/CFSP
   of 6 June 2005
   concerning the implementation of Common Position 2004/694/CFSP on further measures in support of the effective implementation of the mandate of the International Criminal Tribunal for the former Yugoslavia (ICTY)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to Common Position 2004/694/CFSP (1) and in particular Article 2 thereof, in conjunction with the second indent of Article 23(2) of the Treaty on European Union,
   Whereas:

               (1)

               Under the terms of Common Position 2004/694/CFSP the Council adopted measures in order to freeze all funds and economic resources belonging to natural persons indicted by the International Criminal Tribunal for the former Yugoslavia (ICTY).

               (2)

               On 18 April 2005 the Council adopted Decision 2005/316/CFSP containing the latest amendments to the list in the Annex to Common Position 2004/694/CFSP.

               (3)

               Following the transfer of Mr Vujadin POPOVIC and Mr Nebojsa PAVKOVIC to ICTY detention units, their names should be removed from the list.

               (4)

               On 22 April 2005 the ICTY adopted an ‘Order granting leave to withdraw without prejudice the indictment against Goran BOROVNICA’, presumed dead. His name too should be removed from the list.

               (5)

               It is necessary to adapt the list contained in the Annex to Common Position 2004/694/CFSP accordingly,

         HAS DECIDED AS FOLLOWS:
   Article 1
   The list of persons set out in the Annex to Common Position 2004/694/CFSP shall be replaced by the text set out in the Annex to this Decision.
   Article 2
   This Decision shall take effect on the date of its adoption.
   Article 3
   This Decision shall be published in the Official Journal of the European Union.

      Done at Luxembourg, 6 June 2005.

            For the Council

            The President

         J. KRECKÉ

      (1)  OJ L 315, 14.10.2004, p. 52. Common Position as last amended by Decision 2005/316/CFSP (OJ L 100, 20.4.2005, p. 54).

      ANNEX

            ‘ANNEX
            List of persons referred to in Article 1

                        Name: DJORDJEVIC Vlastimir
                        Date of birth: 1948
                        Place of birth: Vladicin Han, Serbia and Montenegro
                        Nationality: Serbia and Montenegro

                        Name: GOTOVINA Ante
                        Date of birth: 12.10.1955
                        Place of birth: Island of Pasman, Municipality of Zadar, Republic of Croatia
                        Nationality: Croatian — French

                        Name: HADZIC Goran
                        Date of birth: 7.9.1958
                        Place of birth: Vinkovci, Republic of Croatia
                        Nationality: Serbia and Montenegro

                        Name: KARADZIC Radovan
                        Date of birth: 19.6.1945
                        Place of birth: Petnjica, Savnik, Montenegro, Serbia and Montenegro
                        Nationality: Bosnia and Herzegovina

                        Name: LUKIC Milan
                        Date of birth: 6.9.1967
                        Place of birth: Visegrad, Bosnia and Herzegovina
                        Nationality: Bosnia and Herzegovina
                        Possibly Serbia and Montenegro

                        Name: LUKIC Sredoje
                        Date of birth: 5.4.1961
                        Place of birth: Visegrad, Bosnia and Herzegovina
                        Nationality: Bosnia and Herzegovina
                        Possibly Serbia and Montenegro

                        Name: MLADIC Ratko
                        Date of birth: 12.3.1942
                        Place of birth: Bozanovici, Municipality of Kalinovik, Bosnia and Herzegovina
                        Nationality: Bosnia and Herzegovina
                        Possibly Serbia and Montenegro

                        Name: TOLIMIR Zdravko
                        Date of birth: 27.11.1948
                        Place of birth:
                        Nationality: Bosnia and Herzegovina

                        Name: ZELENOVIC Dragan
                        Date of birth: 12.2.1961
                        Place of birth: Foca, Bosnia and Herzegovina
                        Nationality: Bosnia and Herzegovina

                        Name: ZUPLJANIN Stojan
                        Date of birth: 22.9.1951
                        Place of birth: Kotor Varos, Bosnia and Herzegovina
                        Nationality: Bosnia and Herzegovina’


Avis juridique important

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32004D0210

2004/210/EC: Commission Decision of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment (Text with EEA relevance)

Official Journal L 066 , 04/03/2004 P. 0045 - 0050

Commission Decisionof 3 March 2004setting up Scientific Committees in the field of consumer safety, public health and the environment(Text with EEA relevance)(2004/210/EC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community, and in particular Articles 152 and 153 thereof,Whereas:(1) The Scientific Committees were established by Commission Decision 97/404/EC of 10 June 1997 setting up a Scientific Steering Committee(1) and by Commission Decision 97/579/EC of 23 July 1997 setting up Scientific Committees in the field of consumer health and food safety(2).(2) The responsibilities of the Scientific Steering Committee (SSC) in relation to scientific advice on bovine spongiform encephalophathy and transmissible spongiform encephalopathies have been transferred to the European Food Safety Authority (EFSA) established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down the procedures in matters of food safety(3).(3) Also the responsibilities of five of the eight Scientific Committees established by Decision 97/579/EC have been transferred to EFSA namely the responsibilities of the Scientific Committee on Food, the Scientific Committee on Animal Nutrition, the Scientific Committee on Animal Health and Animal Welfare the Scientific Committee on Veterinary Measures relating to Public Health, and of the Scientific Committee on Plants.(4) The terms of office of the members of the remaining three Scientific Committees established by Commission Decision 97/579/EC, namely the Scientific Committees on Cosmetic Products and Non-food Products intended for Consumers, the Scientific Committee on Medicinal Products and Medical Devices and the Scientific Committee on Toxicity, Ecotoxicity and the Environment have come to an end. Members of those committees remain in office until they are replaced or their appointments are renewed.(5) It is therefore necessary to replace Decision 97/404/EC and Decision 97/579/EC and to repeal these acts.(6) Sound and timely scientific advice is an essential requirement for Commission proposals, decisions and policy relating to consumer safety, public health and the environment.(7) The advice of the Scientific Committees on matters relating to consumer safety, public health and the environment must be based on the principles of excellence, independence and impartiality, and transparency, as developed in the Commission Communication on "The collection and use of expertise by the Commission: principles and guidelines. Improving the knowledge for better policies"(4).(8) It is essential that the Scientific Committees make best use of external expertise in the EU and beyond as may be necessary for a specific question.(9) It is timely to reorganise the Scientific Committee advisory structure in the light of operational experience, the establishment of the EFSA and the Commission's future needs for independent scientific advice. Such a structure must provide the flexibility to allow it to advise the Commission on matters falling under established areas of competence as well as on emerging and newly identified health risks and matters not within the competence of other Community risk assessment bodies.(10) The need for independent scientific advice both in established and new areas of Community responsibilities falling within the competence of the Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers and the Scientific Committee on Toxicity, Ecotoxicity and the Environment is likely to continue to increase.(11) The number of requests for scientific advice from the Scientific Committee on Medicinal Products and Medical Devices are too few to justify its continuation as a separate Committee. However, in view of the potential importance of this area and in particular of medical devices, it is necessary to retain the capacity to provide scientific advice through an appropriate Scientific Committee.(12) In order to strengthen their scientific coherence, synergisms and a multi-disciplinary approach and at the same time minimise overlapping responsibility, it is necessary to redefine the fields of competence of the Scientific Committees and to ensure systematic and structured coordination.(13) It is important that the Commission can take a proactive approach to the early assessment of emerging and other newly identified risks,HAS DECIDED AS FOLLOWS:Article 1Scientific Committee advisory structure and fields of competence1. The following Scientific Committees are hereby established:(a) the Scientific Committee on Consumer Products (hereinafter SCCP).(b) the Scientific Committee on Health and Environmental Risks (hereinafter SCHER).(c) the Scientific Committee on Emerging and Newly Identified Health Risks (hereinafter SCENIHR).2. The fields of competence of the Scientific Committees shall be as set out in Annex I, without prejudice to the competence conferred by Community legislation to other Community bodies undertaking risk assessment, such as the European Food Safety Authority and the European Agency for the Evaluation of Medicinal Products.Article 2Mission1. The Commission shall request a scientific opinion from the Scientific Committees in the cases laid down by Community law. The Commission may also request an opinion from the Committees on questions:(a) of particular relevance to consumer safety, public health and the environment; and(b) not falling within the mandate of other Community bodies.2. Requests for a scientific opinion on questions which do not fall within the fields of competence of a single scientific committee or which need to be considered by more than one Committee, shall be addressed in accordance with the rules of procedures set out in Article 10(2)(c). The same shall apply to needs for clarification of requests for scientific opinions in accordance with the rules of procedure set out in Article 10(2)(b).3. The Commission may require the adoption of a scientific opinion from a Scientific Committee within a specified period.4. The Scientific Committees shall draw the Commission's attention to a specific or emerging problem falling within their remit, which they consider may pose an actual or potential risk to consumer safety, public health or the environment. The Commission shall determine the action to be taken including, if appropriate, a request for a scientific opinion on the matter.5. Subject to paragraph 3, a Scientific Committee may require additional information from stakeholders for the completion of a scientific opinion.A Scientific Committee may give a deadline for submitting the required information to it. If the required information has not been submitted within that deadline, the Committee may adopt its opinion on the basis of the available information.Article 3Appointment of the members of the Scientific Committees and associated members1. The SCCP and the SCHER shall each consist of a maximum of 19 members. They shall be appointed on the basis of their expertise and consistent with this a geographical distribution that reflects the diversity of scientific problems and approaches in the Community. The Commission shall determine the number of members in each committee in accordance with the requisite needs.2. The SCENIHR shall be composed of 13 members. They shall be appointed on the basis of their broad expertise in the application of risk assessment and, consistent with this, a geographical distribution that reflects the diversity of scientific problems and approaches in the Community.For any specific question, the SCENIHR may enlist the support of up to six associated members selected on the basis of their expertise. Associated members shall have the same rights to participate in the discussions and responsibilities as members.3. The members of each Scientific Committee shall be scientific experts in one or more of the fields of competence of that Committee and shall collectively cover the widest possible range of disciplines.4. The Commission shall appoint the members of the Scientific Committees from a list of suitable candidates established following publication in the Official Journal of the European Union and on the Commission website of a call for expressions of interest.5. No member of a Scientific Committee may be appointed to more than one of the Committees set out in Article 1(1).Article 4Constitution of a reserve list1. Candidates found suitable for the position in a Scientific Committee but not appointed shall be invited to be included on a reserve list. The reserve list may be used by:(a) the Commission to identify suitable candidates to replace members in accordance with Article 7(2);(b) the SCENIHR to identify associated members having the required expertise for specific questions;(c) the Scientific Committees to identify external experts in working groups;2. Associated members shall be selected from the reserve list or from lists established by other Community bodies following open selection procedures designed to fulfil the requirements for excellence and independence.Article 5Election of the Chairs and Vice-chairs1. Each Scientific Committee shall elect a Chair and two Vice-Chairs from among their members. The election shall take place by simple majority of the members which make up the Committee. The term of office of the Chair and Vice-Chair shall be three years, renewable.2. The procedure for the election of the Chair and Vice-Chairs of the Scientific Committees shall be laid down in the rules of procedures.Article 6Coordination of the Scientific CommitteesThe Chairs shall assist the Commission on matters relating to the coordination of the three Scientific Committees in accordance with the rules of procedures referred to in Article 10(2)(d).Article 7Terms of office1. Members shall be appointed to the Scientific Committees for a term of three years, and may not serve for more than three consecutive terms. They shall remain in office until they are replaced or their appointments are renewed.Members who have just completed three consecutive terms of office in a Scientific Committee shall be eligible for membership of another Scientific Committee.2. When it is found that a member does not participate to the work of a Scientific Committees or wishes to resign, the Commission may terminate the member's membership and appoint a replacement from the reserve list provided for in Article 4.Article 8Working groups and participation of external experts1. In agreement with the Commission, the Scientific Committees may invite specialised external experts that they consider to have the relevant scientific knowledge and expertise to contribute to their work.2. The Scientific Committees may create specific working groups with clearly defined tasks. These working groups shall be established in particular when there is a need for external expertise to fulfil the mandate of the Committee. In such cases, it shall draw on the expertise of those working groups when adopting scientific opinions.3. The working groups shall be chaired by a member of the Scientific Committee that convened them and shall report to it.4. When a question is common to more than one Scientific Committee, a common working group including members from the Committees, associated members concerned and external experts as necessary shall be set up.Article 9Reimbursements and indemnitiesMembers of the Scientific Committees, Associated Members and the external experts shall be entitled to an indemnity for their participation in the meetings of the Committees and for serving as Rapporteur on a specific question, as provided for in Annex II.Reimbursement of travel and subsistence costs shall be paid by the Commission.Article 10Rules of procedures1. The Scientific Committees shall adopt common rules of procedure in consultation with the Commission. The rules of procedure shall ensure that the Scientific Committees perform their tasks in compliance with the principles of excellence, independence and transparency, whilst having regard to legitimate requests for commercial confidentiality.2. The rules of procedure shall cover in particular:(a) the election of the Chair and Vice-Chairs of the Scientific Committee;(b) the procedures for:(i) the coordination and allocation of questions,(ii) the adoption of opinions under normal conditions, and(iii) the adoption of opinions under an accelerated, written procedure if the urgency of the matter requires such a procedure;(c) the designation of the Scientific Committee responsible for dealing with questions common to more than one Scientific Committee;(d) the procedures for ensuring coordination between the Scientific Committees including matters relating to harmonisation of risk assessment;(e) the creation and organisation of the working groups of the Scientific Committees;(f) the involvement of external experts and, for the SCENIHR, of associated members;(g) the appointment of Rapporteurs and the description of their tasks in relation to the preparation of draft opinions for the Scientific Committees;(h) the format and content of scientific opinions and procedures for ensuring and improving their coherence;(i) procedures for identifying, resolving or clarifying diverging opinions with Community and international bodies carrying out similar tasks, including information exchange and the organisation of joint meetings;(j) the organisation of hearings with industry or other special interest groups;(k) the responsibilities and obligations of members, associated members and external experts in relation to their contacts with petitioners, special interest groups and other stakeholders;(l) representation of a Scientific Committee in external activities, notably in relation to other Community or international bodies engaged in overlapping activities.Article 11Voting rulesEach Scientific Committees shall act by a majority of its members.Article 12Adoption of scientific opinionsThe Scientific Committees shall adopt their opinions by a majority of the Members which make up the Committee.Article 13Diverging opinions1. The Scientific Committees shall assist the Commission in identifying at an early stage potential or actual divergence between their scientific opinions and the scientific opinions of Community and International bodies carrying out similar tasks. They shall assist the Commission in avoiding, resolving or clarifying divergent opinions.2. Where a substantive divergence over scientific issues has been identified and the body in question is a Community body, the Scientific Committee concerned shall, on the request of the Commission, cooperate with the body concerned with a view to either resolving the divergence or presenting a joint document to the Commission clarifying the contentious scientific issues and identifying the relevant uncertainties in the data. This document shall be made public.Article 14Independence1. The Members of the Scientific Committees and associated members shall be nominated in a personal capacity. They shall not delegate their responsibilities to another member or to a third person.2. Members of the Scientific Committees and associated members shall undertake to act independently of any external influence.For that purpose they shall make a declaration of commitment to act in the public interest and a declaration of interests indicating either the absence or existence of any interest which might be considered prejudicial to their independence.These declarations shall be made in writing and be publicly available. Members of the Scientific Committees shall make annual declarations.3. Members of the Scientific Committees, associated members and the external experts participating in working groups shall declare at each meeting any specific interest which might be considered as prejudicial to their independence in relation to the items on the agenda.Article 15Transparency1. Request for opinions, agendas, minutes and opinions of the Scientific Committees shall be published without undue delay and with regard to the need for commercial confidentiality.2. Minority opinions shall always be included in the opinions of the Scientific Committees and shall be attributed to the members or associated members concerned.3. The rules of procedures shall be published on the Commission's website.4. The names of the members of the Scientific Committees shall be published in the Official Journal of the European Union. They shall also be made available on the Commission's website together with a brief Curriculum vitae of each member.The names of participants in the working groups shall be given with the opinion to which they have contributed.5. The reserve list resulting from the call for expressions of interest shall be published in the Official Journal of the European Union. It shall also be made available on the Commission's website.Article 16ConfidentialityThe members of the Scientific Committees, associated members and external experts shall not divulge information acquired as a result of the work of the Scientific Committees, or one of the working groups, when they are informed that it is confidential.Article 17Secretariat of the Commission's Scientific Committees1. The Scientific Committees and their working groups shall be convened by the Commission.2. The Commission shall provide the scientific and administrative secretariat of the Scientific Committees and their working groups.3. The secretariat shall be responsible for providing scientific and administrative support necessary to facilitate the efficient functioning of the Scientific Committees in compliance with the rules of procedure, particularly in relation to the requirements for excellence, independence and transparency.4. The secretariat shall ensure the scientific and technical coordination of the activities of the Scientific Committees and where necessary coordination of their activities with those of other Community and international bodies.Article 18Replacement of the Scientific CommitteesThe Scientific Committees established by Article 1(1) of this Decision shall replace the existing Scientific Committees established by Decision 97/579/EC as follows:(a) the Scientific Committee on Consumer Products shall replace the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers;(b) the Scientific Committee on the Health and Environmental Risks shall replace the Scientific Committee on Toxicity, Ecotoxicity and the Environment;(c) the Scientific Committee on Emerging and Newly Identified Health Risks shall replace the Scientific Committee on Medicinal Products and Medical Devices.Article 19Repeals1. Decisions 97/404/EC and 97/579/EC are repealed.However, the three Committees established by those decisions shall remain in office until the Scientific Committees established by this Decision take office.2. References to the repealed decisions shall be understood as applicable to this Decision; references to the Committees and sections established by the repealed decisions shall be understood as applicable to the Committees established by this Decision.Done at Brussels, 3 March 2004.For the CommissionDavid ByrneMember of the Commission(1) OJ L 169, 27.6.1997, p. 85; Decision as amended by Decision 2000/443/EC (OJ L 179, 18.7.2000, p. 13).(2) OJ L 237, 28.8.1997, p. 18; Decision as amended by Decision 2000/443/EC.(3) OJ L 31, 1.2.2002, p. 1; Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).(4) COM (2002) 713 final of 11 December 2002 on "The collection and use of expertise by the Commission: principles and guidelines. Improving the knowledge for better policies".ANNEX IFIELD OF COMPETENCE1. Scientific Committee on Consumer ProductsIt shall provide opinions on questions concerning the safety of consumer products (non-food products intended for the consumer). In particular, it shall address questions in relation to the safety and allergenic properties of cosmetic products and ingredients with respect to their impact on consumer health, toys, textiles, clothing, personal care products, domestic products such as detergents and consumer services such as tattooing.2. Scientific Committee on Health and Environmental RisksIt shall provide opinions on questions relating to examinations of the toxicity and ecotoxicity of chemical, biochemical and biological compounds whose use may have a harmful consequences for human health and the environment. In particular, it shall address questions in relation to new and existing chemicals, the restriction and marketing of dangerous substances, biocides, waste, environmental contaminants, plastic and other materials used for water pipework (e.g. new organics substances), drinking water, indoor and ambient air quality.It shall address questions relating to human exposure to mixtures of chemicals, sensitisation and identification of endocrine disrupters.3. The Scientific Committee on Emerging and Newly Identified Health RisksIt shall provide opinions on questions concerning emerging or newly identified risks and on broad, complex or multidisciplinary issues requiring a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other Community risk assessment bodies.Examples of potential areas of activity include potential risks associated with interaction of risk factors, synergic effects, cumulative effects, antimicrobial resistance, new technologies such as nanotechnologies, medical devices including those incorporating substances of animal and/or human origin, tissue engineering, blood products, fertility reduction, cancer of endocrine organs, physical hazards such as noise and electromagnetic fields (from mobile phones, transmitters and electronically controlled home environments), and methodologies for assessing new risks.ANNEX IIINDEMNITIESMembers of the Scientific Committees, Associated Members and the external experts shall be entitled to indemnities related to their participation in the activities of the scientific committees as follows:For participation at meetings:- EUR 300 for each full day participation or EUR 150 for participation in a morning or afternoon meeting of a Scientific Committee, a working group or at an external meeting attended in connection with the work of a Scientific Committee.For acting as Rapporteur for a question requiring not less than one day of preparation of a draft opinion and with the prior written agreement of the Commission:- EUR 300.- Where fully justified and subject to budget availability, this sum may be exceptionally increased to EUR 600 for questions which are particularly demanding in terms of work load.For particularly complex questions of a multidisciplinary nature, more than one Rapporteur may be appointed.


title: Council Decision of 26 May 2016 appointing four members of the Management Board of the European Medicines Agency

text:
               3.6.2016

               EN

               Official Journal of the European Union

               C 197/2

         COUNCIL DECISION
   of 26 May 2016
   appointing four members of the Management Board of the European Medicines Agency
   (2016/C 197/02)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (1), and in particular Article 65(1) and (4) thereof,
   Whereas:

               (1)

               On 27 January 2016, the Commission, acting in accordance with Article 65(1) of Regulation (EC) No 726/2004, presented a list of candidates, representatives of patients' organisations, doctors' organisations and veterinarians' organisations, to be appointed to the Management Board of the European Medicines Agency.

               (2)

               The European Parliament considered that list of candidates and submitted its views thereon to the Council on 21 April 2016,

         HAS ADOPTED THIS DECISION:
   Article 1
   The following are hereby appointed members of the Management Board of the European Medicines Agency for a 3-year period from 15 June 2016:

               PATIENTS' ORGANISATIONS

               DOCTORS' ORGANISATIONS

               VETERINARIANS' ORGANISATIONS

               Mr Yann LE CAM
               Ms Ilaria PASSARANI

               Mr Wolf-Dieter LUDWIG

               Ms Nancy DE BRIYNE

         Article 2
   This Decision shall enter into force on the date of its adoption.

      Done at Brussels, 26 May 2016.

            For the Council

            The President

         H.G.J. KAMP

      (1)  OJ L 136, 30.4.2004, p. 1.


title: Commission Decision (EU) 2015/1302 of 28 July 2015 on the identification of ‘Integrating the Healthcare Enterprise’ profiles for referencing in public procurement (Text with EEA relevance)

text:
               29.7.2015

               EN

               Official Journal of the European Union

               L 199/43

         COMMISSION DECISION (EU) 2015/1302
   of 28 July 2015
   on the identification of ‘Integrating the Healthcare Enterprise’ profiles for referencing in public procurement
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (1) and in particular Article 13(1) thereof,
   After consulting the European multi-stakeholder platform on ICT standardisation and sectoral experts,
   Whereas:

               (1)

               Standardisation plays an important role in supporting the Europe 2020 strategy, as set out in the Communication from the Commission entitled ‘Europe 2020: A strategy for smart, sustainable and inclusive growth’ (2). Several flagship initiatives of the Europe 2020 strategy underline the importance of voluntary standardisation in product or services markets to assure the compatibility and interoperability between products and services, foster technological development and support innovation.

               (2)

               The completion of the Digital Single Market is a key priority for the European Union as highlighted in the Annual Growth Strategy 2015 (3). The Commission has launched the Digital Single Market strategy (4) where the role of standardisation and interoperability in creating a European Digital Economy with a long-term growth potential is highlighted.

               (3)

               In the digital society standardisation deliverables become indispensable to ensure the interoperability between devices, applications, data repositories, services and networks. The Communication from the Commission entitled ‘A strategic vision for European standards: moving forward to enhance and accelerate the sustainable growth of the European economy by 2020’ (5) recognises the specificity of ICT standardisation where ICT solutions, applications and services are often developed by global ICT Fora and Consortia that have emerged as leading ICT standards development organisations.

               (4)

               Regulation (EU) No 1025/2012 aims at modernising and improving the European standardisation framework. It establishes a system whereby the Commission may decide to identify the most relevant and most widely accepted ICT technical specifications issued by organisations that are not European, international or national standardisation organisations. The possibility to use the full range of ICT technical specifications when procuring hardware, software and information technology services will enable interoperability, will help avoid lock-in for public administrations and will encourage competition in the supply of interoperable ICT solutions.

               (5)

               The ICT technical specifications that may be eligible for referencing in public procurement must comply with the requirements set out in Annex II to Regulation (EU) No 1025/2012. Compliance with those requirements guarantees the public authorities that the ICT technical specifications are established in accordance with the principles of openness, fairness, objectivity and non-discrimination that are recognised by the World Trade organisation in the field of standardisation.

               (6)

               The decision to identify the ICT specification is to be adopted after consultation of the European multi-stakeholder platform on ICT standardisation set up by Commission Decision 2011/C 349/04 (6) complemented by other forms of consultation of sectoral experts.

               (7)

               On 2 October 2014, the European multi-stakeholder platform on ICT standardisation evaluated 27 ‘Integrating the Healthcare Enterprise’ (IHE) profiles against the requirements set out in Annex II to Regulation (EU) No 1025/2012 and gave a positive advice to their identification for referencing in public procurement. The evaluation of the 27 IHE profiles was subsequently submitted to consultation of the eHealth network established by Article 14 of Directive 2011/24/EU of the European Parliament and of the Council (7) that confirmed the positive advice to their identification.

               (8)

               IHE develops ICT technical specifications in the field of healthcare information technology. The 27 IHE profiles are detailed specifications developed over a period of 15 years within the committees of IHE that optimise the selection of well-established standards describing the different layers of interoperability (i.e. protocol communication, technical, syntactical, semantic and application levels) with a view to find interoperability solutions for exchanging or sharing medical data.

               (9)

               The 27 IHE profiles have the potential to increase interoperability of eHealth services and applications to the benefit of patients and medical community. The 27 IHE profiles should therefore be identified as ICT technical specifications eligible for referencing in public procurement,

         HAS ADOPTED THIS DECISION:
   Article 1
   The ‘Integrating the Healthcare Enterprise’ profiles listed in the Annex are eligible for referencing in public procurement.
   Article 2
   This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      Done at Brussels, 28 July 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 316, 14.11.2012, p. 12.

      (2)  COM(2010) 2020 final of 3 March 2010.

      (3)  COM(2014) 902.

      (4)  Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on a Digital Single Market Strategy for Europe COM(2015) 192 final of 6 May 2015.

      (5)  COM(2011) 311 final of 1 June 2011.

      (6)  Commission Decision 2011/C 349/04 of 28 November 2011 setting up the European multi-stakeholder platform on ICT standardisation (OJ C 349, 30.11.2011, p. 4).

      (7)  Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

      ANNEX

         LIST OF ‘INTEGRATING THE HEALTHCARE ENTERPRISE’ PROFILES ELIGIBLE FOR REFERENCING IN PUBLIC PROCUREMENT

                  1.

                  IHE XCPD: Cross-Community Patient Discovery;

                  2.

                  IHE XCA: Cross-Community Access;

                  3.

                  IHE XCF: Cross-Community Fetch;

                  4.

                  IHE XDR: Cross-Enterprise Document Reliable Interchange;

                  5.

                  IHE CT: Consistent Time;

                  6.

                  IHE ATNA: Audit Trail and Node Authentication;

                  7.

                  IHE BPPC: Basic Patient Privacy Consents;

                  8.

                  IHE XUA: Cross-Enterprise User Assertion;

                  9.

                  IHE PRE: Pharmacy Prescription;

                  10.

                  IHE DIS: Pharmacy Dispense;

                  11.

                  IHE XPHR: Exchange of Personal Health Record Content;

                  12.

                  IHE XD-MS: Cross-Enterprise Sharing of Medical Summaries Integration Profile;

                  13.

                  IHE XD-SD: Cross-Enterprise Sharing of Scanned Documents;

                  14.

                  IHE PIX: Patient Identifier Cross-Referencing;

                  15.

                  IHE PDQ: Patient Demographics Query;

                  16.

                  IHE XDS.b: Cross-Enterprise Document Sharing;

                  17.

                  IHE XDS-I.b: Cross-Enterprise Document Sharing for Imaging;

                  18.

                  IHE XD-LAB: Laboratory Reports;

                  19.

                  IHE XDM: Cross-Enterprise Document Media Interchange;

                  20.

                  IHE SVS: Sharing Value Sets;

                  21.

                  IHE SWF: Radiology Scheduled Workflow;

                  22.

                  IHE SWF.b: Radiology Scheduled Workflow;

                  23.

                  IHE PIR: Patient Information Reconciliation;

                  24.

                  IHE PAM: Patient Administration Management;

                  25.

                  IHE LTW: Laboratory Testing Workflow;

                  26.

                  IHE LCSD: Laboratory Code Sets Distribution;

                  27.

                  IHE LWA: Laboratory Analytical Workflow.


title: Council Decision of 25 February 2009 appointing and replacing members of the Governing Board of the European Centre for the Development of Vocational Training

text:
               3.6.2009

               EN

               Official Journal of the European Union

               C 123/10

      COUNCIL DECISION

   of 25 February 2009
   appointing and replacing members of the Governing Board of the European Centre for the Development of Vocational Training
   2009/C 123/04
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to Council Regulation (EEC) No 337/75 of 10 February 1975 establishing the European Centre for the Development of Vocational Training, and in particular Article 4 thereof (1),
   Having regard to the nominations submitted by the Government of CYPRUS,
   Whereas:

               (1)

               By its Decision of 18 September 2006 (2), the Council appointed the members of the Governing Board of the European Centre for the Development of Vocational Training for the period from 18 September 2006 to 17 September 2009.

               (2)

               A member's seat on the Governing Board of the Centre in the category of Government representatives has become vacant as a result of the resignation of Mr Michael PHYSENTZIDES.

               (3)

               The Cypriot member of the Governing Board of the aforementioned Centre should be appointed for the remainder of the current term of office, which expires on 17 September 2009,

         HAS DECIDED AS FOLLOWS:
   Sole Article
   The following person is hereby appointed as a member of the Governing Board of the European Centre for the Development of Vocational Training for the remainder of the term of office, which runs until 17 September 2009:

      GOVERNMENT REPRESENTATIVE

   CYPRUS: Dr. George OXINOS

      Done at Brussels, 25 February 2009.

            For the Council

            The President

         J. ŠEBESTA

      (1)  OJ L 39, 13.2.1975, p. 1.

      (2)  OJ C 240, 5.10.2006, p. 1.


title: 2011/126/EU: Council Decision of 21 February 2011 concerning the conclusion of the Agreement between the European Community and the West African Economic and Monetary Union on certain aspects of air services

text:
               25.2.2011

               EN

               Official Journal of the European Union

               L 51/1

         COUNCIL DECISION
   of 21 February 2011
   concerning the conclusion of the Agreement between the European Community and the West African Economic and Monetary Union on certain aspects of air services
   (2011/126/EU)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2) in conjunction with Article 218(6)(a) and the first subparagraph of Article 218(8),
   Having regard to the proposal from the European Commission,
   Having regard to the consent of the European Parliament,
   Whereas:

               (1)

               The Council authorised the Commission on 5 June 2003 to open negotiations with third countries on the replacement of certain provisions in existing bilateral Agreements with a Community Agreement.

               (2)

               On behalf of the European Community, the Commission has negotiated an Agreement with the West African Economic and Monetary Union on certain aspects of air services in accordance with the mechanisms and directives in the Annex to the Council Decision authorising the Commission to open negotiations with third countries on the replacement of certain provisions in existing bilateral agreements with a Community Agreement.

               (3)

               The Agreement was signed on behalf of the Community on 30 November 2009 subject to its possible conclusion at a later date, in accordance with Council Decision 2010/144/EC (1).

               (4)

               As a consequence of the entry into force of the Treaty of Lisbon on 1 December 2009, the European Union has replaced and succeeded the European Community.

               (5)

               The Agreement should be approved,

         HAS ADOPTED THIS DECISION:
   Article 1
   The Agreement between the European Community and the West African Economic and Monetary Union on certain aspects of air services (‘the Agreement’), is hereby approved on behalf of the Union.
   Article 2
   The President of the Council shall, on behalf of the Union, give the notification provided for in Article 9(1) of the Agreement and make the following notification:

      ‘As a consequence of the entry into force of the Treaty of Lisbon on 1 December 2009, the European Union has replaced and succeeded the European Community and from that date exercises all rights and assumes all obligations of the European Community. Therefore, references to “the European Community” in the text of the Agreement are, where appropriate, to be read as “the European Union”.’

   Article 3
   This Decision shall enter into force on the day after its adoption.

      Done at Brussels, 21 February 2011.

            For the Council

            The President

         MARTONYI J.

      (1)  OJ L 56, 6.3.2010, p. 15.