title: Commission Decision (EU) 2017/1219 of 23 June 2017 establishing the EU Ecolabel criteria for industrial and institutional laundry detergents (notified under document C(2017) 4245) (Text with EEA relevance. )

text:
                  12.7.2017

                  EN

                  Official Journal of the European Union

                  L 180/79

            COMMISSION DECISION (EU) 2017/1219
      of 23 June 2017
      establishing the EU Ecolabel criteria for industrial and institutional laundry detergents

            (notified under document C(2017) 4245)

      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (1), and in particular Article 8(2) thereof,
      After consulting the European Union Eco-labelling Board,
      Whereas:

                  (1)

                  Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

                  (2)

                  Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established for each product group.

                  (3)

                  Commission Decision 2012/721/EU (2) has established the ecological criteria and the related assessment and verification requirements for industrial and institutional laundry detergents, which are valid until 14 November 2016.

                  (4)

                  In order to take into account the recent market developments and the innovation that has taken place during the intervening period, it is considered appropriate to establish a revised set of ecological criteria for that product group.

                  (5)

                  The revised criteria, as well as the related assessment and verification requirements, should be valid for 6 years from the date of notification of this Decision, taking into account the innovation cycle for that product group. Those criteria aim at promoting products that have a reduced impact on aquatic ecosystems, contain a limited amount of hazardous substances, are effective at the recommended temperatures, and minimise waste production by reducing packaging.

                  (6)

                  For reasons of legal certainty, Decision 2012/721/EU should be repealed.

                  (7)

                  A transitional period should be allowed for producers whose products have been awarded the EU Ecolabel for industrial and institutional laundry detergents on the basis of the criteria set out in Decision 2012/721/EU, so that they have sufficient time to adapt their products to comply with the revised criteria and requirements.

                  (8)

                  The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

            HAS ADOPTED THIS DECISION:
      Article 1
      The product group ‘industrial and institutional laundry detergents’ shall comprise any laundry detergent falling under the scope of Regulation (EC) No 648/2004 of the European Parliament and of the Council (3) which is marketed and designed to be used by specialised personnel in industrial and institutional facilities.
      This product group includes multi-component systems comprised of more than one component used to build up a complete detergent or a laundering programme for an automatic dosing system. Multi-component systems may incorporate a number of products such as fabric softeners, stain removers and rinsing agents, and they shall be tested as a whole.
      This product group shall not comprise products which induce textile attributes such as water repellency, waterproofness or fire retardancy. Furthermore, the product group shall not comprise products that are dosed by carriers such as sheets, cloths or other materials, or washing auxiliaries used without subsequent washing such as stain removers for carpets and furniture upholstery.
      Laundry detergents to be used in household washing machines are excluded from the scope of this product group.
      Article 2
      For the purpose of this Decision, the following definitions shall apply:

                  (1)

                  ‘ingoing substances’ means substances intentionally added, by-products and impurities from raw materials in the final product formulation (including water-soluble foil, if used);

                  (2)

                  ‘primary packaging’ means:

                              (a)

                              for single doses in a wrapper that is intended to be removed before use, the individual dose wrapping and the packaging conceived so as to constitute the smallest sales unit of distribution to the final user or consumer at the point of purchase, including label where applicable;

                              (b)

                              for all other types of products, packaging conceived so as to constitute the smallest sales unit of distribution to the final user or consumer at the point of purchase, including label where applicable;

                  (3)

                  ‘microplastic’ means particles with a size of below 5 mm of insoluble macromolecular plastic, obtained through one of the following processes:

                              (a)

                              a polymerisation process such as e.g. polyaddition or polycondensation or a similar process using monomers or other starting substances;

                              (b)

                              chemical modification of natural or synthetic macromolecules;

                              (c)

                              microbial fermentation;

                  (4)

                  ‘nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm (4).

            Article 3
      In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, a laundry detergent shall fall within the product group ‘industrial and institutional laundry detergents’, as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex.
      Article 4
      The criteria for the product group ‘industrial and institutional laundry detergents’ and the related assessment and verification requirements shall be valid for 6 years from the date of notification of this Decision.
      Article 5
      For administrative purposes the code number assigned to the product group ‘industrial and institutional laundry detergents’ shall be ‘039’.
      Article 6
      Decision 2012/721/EU is repealed.
      Article 7
      1.   By derogation from Article 6, applications for the EU Ecolabel for products falling within the product group ‘industrial and institutional laundry detergents’ submitted before the date of notification of this Decision shall be evaluated in accordance with the conditions laid down in Decision 2012/721/EU.
      2.   Applications for the EU Ecolabel for products falling within the product group ‘industrial and institutional laundry detergents’ submitted within 2 months from the date of notification of this Decision may be based either on the criteria set out in Decision 2012/721/EU or on the criteria set out in this Decision. Those applications shall be evaluated in accordance with the criteria on which they are based.
      3.   EU Ecolabel licenses awarded in accordance with the criteria set out in Decision 2012/721/EU may be used for 12 months from the date of notification of this Decision.
      Article 8
      This Decision is addressed to the Member States.

         Done at Brussels, 23 June 2017.

               For the Commission

            Karmenu VELLA

               Member of the Commission

         (1)  OJ L 27, 30.1.2010, p. 1.

         (2)  Commission Decision 2012/721/EU of 14 November 2012 establishing the ecological criteria for the award of the EU Ecolabel for Industrial and Institutional Laundry Detergents (OJ L 326, 24.11.2012, p. 38).

         (3)  Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1).

         (4)  Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial (OJ L 275, 20.10.2011, p. 38).

         ANNEX

            FRAMEWORK

            EU ECOLABEL CRITERIA

            Criteria for awarding the EU Ecolabel to industrial and institutional laundry detergents

         CRITERIA

                     1.

                     Toxicity to aquatic organisms

                     2.

                     Biodegradability

                     3.

                     Sustainable sourcing of palm oil, palm kernel oil and their derivatives

                     4.

                     Excluded and restricted substances

                     5.

                     Packaging

                     6.

                     Fitness for use

                     7.

                     Automatic dosing systems

                     8.

                     User information

                     9.

                     Information appearing on the EU Ecolabel

               ASSESSMENT AND VERIFICATION
         (a)   Requirements

         The specific assessment and verification requirements are indicated within each criterion.
         Where the applicant is required to provide to competent bodies with declarations, documentation, analyses, test reports, or other evidence to show compliance with the criteria, these may originate from the applicant and/or their supplier(s), as appropriate.
         Competent bodies shall preferentially recognise attestations which are issued by bodies accredited in accordance with the relevant harmonised standard for testing and calibration laboratories and verifications by bodies that are accredited in accordance with the relevant harmonised standard for bodies certifying products, processes and services. Accreditation shall be carried in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council (1).
         Where appropriate, test methods other than those indicated for each criterion may be used if the competent body assessing the application accepts their equivalence.
         Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications or site visits.
         As a prerequisite, the product shall meet all applicable legal requirements of the country or countries in which the product is intended to be placed on the market. The applicant shall declare the product's compliance with this requirement.
         The ‘Detergent Ingredient Database’ list (DID list), available on the EU Ecolabel website, contains the most widely used ingoing substances in detergents and cosmetics formulations. It shall be used for deriving the data for the calculations of the Critical Dilution Volume (CDV) and for the assessment of the biodegradability of the ingoing substances. For substances not present on the DID list, guidance is given on how to calculate or extrapolate the relevant data.
         The list of all ingoing substances shall be provided to the competent body, indicating the trade name (if existing), the chemical name, the CAS no., the DID no., the ingoing quantity, the function and the form present in the final product formulation (including water-soluble foil, if used).
         Preservatives, fragrances and colouring agents shall be indicated regardless of concentration. Other ingoing substances shall be indicated at or above the concentration of 0,010 % weight by weight.
         All ingoing substances present in the form of nanomaterials shall be clearly indicated in the list with the word ‘nano’ written in brackets.
         For each ingoing substance listed, the Safety Data Sheets (SDS) in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) shall be provided. Where an SDS is not available for a single substance because it is part of a mixture, the applicant shall provide the SDS of the mixture.
         (b)   Measurement thresholds

         Compliance with the ecological criteria is required for all ingoing substances as specified in Table 1.

            Table 1

            Threshold levels applicable to ingoing substances by criterion for industrial and institutional laundry detergents (% weight by weight)

                     Criterion name

                     Surfactants

                     Preservatives

                     Colouring agents

                     Fragrances

                     Other (e.g. enzymes)

                     Toxicity to aquatic organisms

                     ≥ 0,010

                     no limit (*1)

                     no limit (*1)

                     no limit (*1)

                     ≥ 0,010

                     Biodegradability

                     Surfactants

                     ≥ 0,010

                     N/A

                     N/A

                     N/A

                     N/A

                     Organics

                     ≥ 0,010

                     no limit (*1)

                     no limit (*1)

                     no limit (*1)

                     ≥ 0,010

                     Sustainable sourcing of palm oil

                     ≥ 0,010

                     N/A

                     N/A

                     N/A

                     ≥ 0,010

                     Excluded or limited substances

                     Specified excluded and limited subst.

                     no limit (*1)

                     no limit (*1)

                     no limit (*1)

                     no limit (*1)

                     no limit (*1)

                     Hazardous subst.

                     ≥ 0,010

                     ≥ 0,010

                     ≥ 0,010

                     ≥ 0,010

                     ≥ 0,010

                     SVHCs

                     no limit (*1)

                     no limit (*1)

                     no limit (*1)

                     no limit (*1)

                     no limit (*1)

                     Fragrances

                     N/A

                     N/A

                     N/A

                     no limit (*1)

                     N/A

                     Preservatives

                     N/A

                     no limit (*1)

                     N/A

                     N/A

                     N/A

                     Colouring agents

                     N/A

                     N/A

                     no limit (*1)

                     N/A

                     N/A

                     Enzymes

                     N/A

                     N/A

                     N/A

                     N/A

                     no limit (*1)

               REFERENCE DOSAGE
         The following dosage shall be taken as the reference dosage for the calculations aiming at documenting compliance with the EU Ecolabel criteria and for testing of washing ability:
         the highest dosage recommended by the manufacturer to wash one kilogram of dry laundry (indicated in g/kg of laundry or ml/kg of laundry) for three degrees of soiling (light, medium and heavy) and water hardness (soft, medium, hard).
         All products in a multi-component system shall be included with the worst case dosage when assessments of the criteria are made.

            Examples of degree of soiling

                     Soiling

                     Degree of soiling

                     Light

                     Hotels: bed linen, bedclothes and towels, etc. (towels may be considered heavily soiled)
                     Cloth hand towel rolls

                     Medium

                     Work clothes: institutions/retail/service, etc.
                     Restaurants: tablecloths, napkins, etc.
                     Mops and mats

                     Heavy

                     Work clothes: industry/kitchen/butchering, etc.
                     Kitchen textiles: clothes, dish towels, etc.
                     Institutions such as hospitals: bed linen, bedclothes, contour sheets, patient clothing, doctor's coat or scrubs/overall, etc.

            Assessment and verification: the applicant shall provide the product label or user instruction sheet that includes the dosing instructions.

            Criterion 1 — Toxicity to aquatic organisms

         The critical dilution volume (CDVchronic) of the product shall not exceed the following limits for the reference dosage.

                     Soft water (< 1,5 mmol CaCO3/l)
                     (l/kg of laundry)

                     Degree of soiling
                     Product type

                     Light

                     Medium

                     Heavy

                     Powder

                     30 000

                     40 000

                     50 000

                     Liquid

                     50 000

                     60 000

                     70 000

                     Multi-component system

                     50 000

                     70 000

                     90 000

                     Medium water (1,5-2,5 mmol CaCO3/l)
                     (l/kg of laundry)

                     Degree of soiling
                     Product type

                     Light

                     Medium

                     Heavy

                     Powder

                     40 000

                     60 000

                     80 000

                     Liquid

                     60 000

                     75 000

                     90 000

                     Multi-component system

                     60 000

                     80 000

                     100 000

                     Hard water (> 2,5 mmol CaCO3/l)
                     (l/kg of laundry)

                     Degree of soiling
                     Product type

                     Light

                     Medium

                     Heavy

                     Powder

                     50 000

                     75 000

                     90 000

                     Liquid

                     75 000

                     90 000

                     120 000

                     Multi-component system

                     75 000

                     100 000

                     120 000

            Assessment and verification: the applicant shall provide the calculation of the CDVchronic of the product. A spreadsheet for calculating the CDVchronic value is available on the EU Ecolabel website.
         The CDVchronic is calculated for all ingoing substances (i) in the product using the following equation:

         Where:

                     dosage(i)

                     :

                     weight (g) of the substance (i) in the reference dose;

                     DF(i)

                     :

                     degradation factor for the substance (i);

                     TFchronic(i)

                     :

                     chronic toxicity factor for the substance (i).

               The values of DF(i) and TFchronic(i) shall be as given in the most updated Part A of the DID list. If an ingoing substance is not included in Part A, the applicant shall estimate the values following the approach described in the Part B of that list and attaching the associated documentation.
         Because of the degradation of certain substances in the wash process, separate rules apply to the following:

                     —

                     hydrogen peroxide (H2O2) — not to be included in calculation of CDV,

                     —

                     peracetic acid — to be included in the calculation as ‘acetic acid’.

            Criterion 2 — Biodegradability

         (a)   Biodegradability of surfactants

         All surfactants shall be readily degradable (aerobically).
         All surfactants classified as hazardous to the aquatic environment: Acute Category 1 (H400) or Chronic Category 3 (H412), in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3) shall be in addition anaerobically biodegradable.
         (b)   Biodegradability of organic compounds

         The content of organic substances in the product that are aerobically non-biodegradable (not readily biodegradable, aNBO) or anaerobically non-biodegradable (anNBO) shall not exceed the following limits for the reference dosage:

                        aNBO (g/kg of laundry)

                                 Soft water (< 1,5 mmol CaCO3/l)

                                 Degree of soiling
                                 Product type

                                 Light

                                 Medium

                                 Heavy

                                 Powder

                                 0,70

                                 1,10

                                 1,40

                                 Liquid

                                 0,50

                                 0,60

                                 0,70

                                 Multi-component system

                                 1,25

                                 1,75

                                 2,50

                                 Medium water (1,5-2,5 mmol CaCO3/l)

                                 Degree of soiling
                                 Product type

                                 Light

                                 Medium

                                 Heavy

                                 Powder

                                 1,10

                                 1,40

                                 1,75

                                 Liquid

                                 0,60

                                 0,70

                                 0,90

                                 Multi-component system

                                 1,75

                                 2,50

                                 3,75

                                 Hard water (> 2,5 mmol CaCO3/l)

                                 Degree of soiling
                                 Product type

                                 Light

                                 Medium

                                 Heavy

                                 Powder

                                 1,40

                                 1,75

                                 2,20

                                 Liquid

                                 0,70

                                 0,90

                                 1,20

                                 Multi-component system

                                 2,50

                                 3,75

                                 4,80

                        anNBO (g/kg of laundry)

                                 Soft water (< 1,5 mmol CaCO3/l)

                                 Degree of soiling
                                 Product type

                                 Light

                                 Medium

                                 Heavy

                                 Powder

                                 0,70

                                 1,10

                                 1,40

                                 Liquid

                                 0,50

                                 0,60

                                 0,70

                                 Multi-component system

                                 1,25

                                 1,75

                                 2,50

                                 Medium water (1,5-2,5 mmol CaCO3/l)

                                 Degree of soiling
                                 Product type

                                 Light

                                 Medium

                                 Heavy

                                 Powder

                                 1,10

                                 1,40

                                 1,75

                                 Liquid

                                 0,60

                                 0,70

                                 0,90

                                 Multi-component system

                                 1,75

                                 2,50

                                 3,75

                                 Hard water (> 2,5 mmol CaCO3/l)

                                 Degree of soiling
                                 Product type

                                 Light

                                 Medium

                                 Heavy

                                 Powder

                                 1,40

                                 1,75

                                 2,20

                                 Liquid

                                 0,70

                                 0,90

                                 1,20

                                 Multi-component system

                                 2,50

                                 3,75

                                 4,80

            Assessment and verification: the applicant shall provide documentation for the degradability of surfactants, as well as the calculation of aNBO and anNBO for the product. A spreadsheet for calculating aNBO and anNBO values is available on the EU Ecolabel website.
         For both the degradability of surfactants and the aNBO and anNBO values for organic compounds, reference shall be made to the most updated DID list.
         For ingoing substances that are not included in Part A of the DID list, the relevant information from literature or other sources, or appropriate test results, showing that they are aerobically and anaerobically biodegradable shall be provided, as described in Part B of that list.
         In the absence of documentation for degradability, an ingoing substance other than a surfactant may be exempted from the requirement for anaerobic degradability if one of the following three alternatives is fulfilled:

                     (1)

                     it is readily degradable and has low adsorption (A < 25 %);

                     (2)

                     it is readily degradable and has high desorption (D > 75 %);

                     (3)

                     it is readily degradable and non-bioaccumulating (4).

               Testing for adsorption/desorption shall be conducted in accordance with OECD Guideline 106.

            Criterion 3 — Sustainable sourcing of palm oil, palm kernel oil and their derivatives

         Ingoing substances used in the products which are derived from palm oil or palm kernel oil shall be sourced from plantations that meet the requirements of a certification scheme for sustainable production that is based on multi-stakeholder organisations that has a broad membership, including NGOs, industry and government and that addresses environmental impacts including on soil, biodiversity, organic carbon stocks and conservation of natural resources.

            Assessment and verification: The applicant shall provide evidence through third-party certificates and chain of custody that palm oil and palm kernel oil used in the manufacturing of the ingoing substances originates from sustainably managed plantations.
         Certificates accepted shall include Roundtable for Sustainable Palm Oil (RSPO) (by identity preserved, segregated or mass balance) or any equivalent or stricter sustainable production scheme.
         For chemical derivatives of palm oil and for palm kernel oil, it shall be acceptable to demonstrate sustainability through book and claim systems such as GreenPalm certificates or equivalent by providing the Annual Communications of Progress (ACOP) declared amounts of procured and redeemed GreenPalm certificates during the most recent annual trading period.

            Criterion 4 — Excluded and restricted substances

         (a)   Specified excluded and restricted substances

         (i)   Excluded substances

         The substances indicated below shall not be included in the product formulation regardless of concentration:

                     —

                     Alkyl phenol ethoxylates (APEOs) and other alkyl phenol derivatives,

                     —

                     Atranol,

                     —

                     Chloroatranol,

                     —

                     Diethylenetriaminepentaacetic acid (DTPA),

                     —

                     Ethylenediaminetetraacetic acid (EDTA) and its salts,

                     —

                     Formaldehyde and its releasers (e.g. 2-bromo-2-nitropropane-1,3-diol, 5-bromo-5-nitro-1,3-dioxane, sodium hydroxyl methyl glycinate, diazolidinylurea) with the exception of impurities of formaldehyde in surfactants based on polyalkoxy chemistry up to a concentration of 0,010 % weight by weight in the ingoing substance,

                     —

                     Glutaraldehyde,

                     —

                     Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC),

                     —

                     Microplastics,

                     —

                     Nanosilver,

                     —

                     Nitromusks and polycyclic musks,

                     —

                     Per-fluorinated alkylates;

                     —

                     Rhodamine B,

                     —

                     Quaternary ammonium salts not readily biodegradable,

                     —

                     Reactive chlorine compounds,

                     —

                     Triclosan,

                     —

                     3-iodo-2-propynyl butylcarbamate.

            Assessment and verification: the applicant shall provide a signed declaration of compliance supported by declarations from suppliers, if appropriate, confirming that the listed substances have not been included in the product formulation regardless of concentration.
         (ii)   Restricted substances

         The substances listed below shall not be included in the product formulation above the concentrations indicated:

                     —

                     2-methyl-2H-isothiazol-3-one: 0,0050 % weight by weight,

                     —

                     1,2-Benzisothiazol-3(2H)-one: 0,0050 % weight by weight,

                     —

                     5-chloro-2-methyl-4-isothiazolin-3-one/2-methyl-4-isothiazolin-3-one: 0,0015 % weight by weight.

               The total phosphorus (P) content calculated as elemental P shall be limited to:

                     —

                     0,50 g/kg of laundry for light soil,

                     —

                     1,00 g/kg of laundry for medium soil,

                     —

                     1,50 g/kg of laundry for heavy soil.

               Fragrance substances subject to the declaration requirement provided in Regulation (EC) No 648/2004 shall not be present in quantities ≥ 0,010 % weight by weight per substance.

            Assessment and verification:

         The applicant shall provide the following documents:

                     (a)

                     if isothiazolinones are used, a signed declaration of compliance supported by declarations from suppliers, if appropriate, confirming that the content of isothiazolinones used is equal to or lower than the limits set;

                     (b)

                     a signed declaration of compliance supported by declarations from suppliers, if appropriate, confirming that the total amount of elemental P is equal to or lower than the limits set. The declaration shall be supported by the calculations of the product's total P-content;

                     (c)

                     a signed declaration of compliance supported by declarations or documentation from suppliers, if appropriate, confirming that the fragrance substances subject to the declaration requirement provided for in Regulation (EC) No 648/2004 are not present above the limits set.

               (b)   Hazardous substances

         (i)   Final product

         The final product shall not be classified and labelled as being acutely toxic, a specific target organ toxicant, a respiratory or skin sensitiser, carcinogenic, mutagenic or toxic for reproduction, or hazardous to the aquatic environment, as defined in Annex I to Regulation (EC) No 1272/2008 and in accordance with the list in Table 2, with the exception listed below:

                     —

                     products containing peracetic acid and hydrogen peroxide used as bleaching agent may be classified and labelled as hazardous to the aquatic environment [Chronic Category 1 (H410), Chronic Category 2 (H411) or Chronic Category 3 (H412)], if the classification and labelling are triggered by the presence of these substances.

               (ii)   Ingoing substances

         The product shall not contain ingoing substances at a concentration limit at or above 0,010 % weight by weight in the final product that meet the criteria for classification as toxic, hazardous to the aquatic environment, respiratory or skin sensitisers, carcinogenic, mutagenic or toxic for reproduction in accordance with Annex I to Regulation (EC) No 1272/2008 and in accordance with the list in Table 2.
         Where stricter, the generic or specific concentration limits determined in accordance with Article 10 of Regulation (EC) No 1272/2008 shall take precedence.

            Table 2

            Restricted hazard classifications and their categorisation

                     Acute toxicity

                     Categories 1 and 2

                     Category 3

                     H300 Fatal if swallowed

                     H301 Toxic if swallowed

                     H310 Fatal in contact with skin

                     H311 Toxic in contact with skin

                     H330 Fatal if inhaled

                     H331 Toxic if inhaled

                     H304 May be fatal if swallowed and enters airways

                     EUH070 Toxic by eye contact

                     Specific target organ toxicity

                     Category 1

                     Category 2

                     H370 Causes damage to organs

                     H371 May cause damage to organs

                     H372 Causes damage to organs through prolonged or repeated exposure

                     H373 May cause damage to organs through prolonged or repeated exposure

                     Respiratory and skin sensitisation

                     Category 1A/1

                     Category 1B

                     H317 May cause allergic skin reaction

                     H317 May cause allergic skin reaction

                     H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled

                     H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled

                     Carcinogenic, mutagenic or toxic for reproduction

                     Categories 1A and 1B

                     Category 2

                     H340 May cause genetic defects

                     H341 Suspected of causing genetic defects

                     H350 May cause cancer

                     H351 Suspected of causing cancer

                     H350i May cause cancer by inhalation

                     H360F May damage fertility

                     H361f Suspected of damaging fertility

                     H360D May damage the unborn child

                     H361d Suspected of damaging the unborn child

                     H360FD May damage fertility. May damage the unborn child

                     H361fd Suspected of damaging fertility. Suspected of damaging the unborn child

                     H360Fd May damage fertility. Suspected of damaging the unborn child

                     H362 May cause harm to breast fed children

                     H360Df May damage the unborn child. Suspected of damaging fertility

                     Hazardous to the aquatic environment

                     Categories 1 and 2

                     Categories 3 and 4

                     H400 Very toxic to aquatic life

                     H412 Harmful to aquatic life with long-lasting effects

                     H410 Very toxic to aquatic life with long-lasting effects

                     H413 May cause long-lasting effects to aquatic life

                     H411 Toxic to aquatic life with long-lasting effects

                     Hazardous to the ozone layer

                     H420 Hazardous to the ozone layer

               This criterion does not apply to ingoing substances covered by Article 2(7)(a) and (b) of Regulation (EC) No 1907/2006 which set out criteria for exempting substances within Annexes IV and V to that Regulation from the registration, downstream user and evaluation requirements. In order to determine whether that exclusion applies, the applicant shall screen any ingoing substance present at a concentration above 0,010 % weight by weight.
         Substances and mixtures included in Table 3 are exempted from point (b)(ii) of Criterion 4.

            Table 3

            Derogated substances

                     Substance

                     Hazard statement

                     Surfactants

                     H400 Very toxic to aquatic life

                     H412 Harmful to aquatic life with long-lasting effects

                     Subtilisin

                     H400 Very toxic to aquatic life

                     H411 Toxic to aquatic life with long-lasting effects

                     Enzymes (*2)

                     H317 May cause allergic skin reaction

                     H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled

                     ε-phthalimido-peroxy-hexanoic acid (PAP) used as bleaching agent at max concentration of 0,6 g/kg of laundry

                     H400 Very toxic to aquatic life

                     H412 Harmful to aquatic life with long-lasting effects

                     Peracetic acid/hydrogen peroxide used as bleaching agent

                     H400 Very toxic to aquatic life

                     H410 Very toxic to aquatic life with long-lasting effects

                     H412 Harmful to aquatic life with long-lasting effects

                     NTA as an impurity in MGDA and GLDA (*3)

                     H351: Suspected of causing cancer

            Assessment and verification: the applicant shall demonstrate compliance with this criterion for the final product and for any ingoing substance present at a concentration greater than 0,010 % weight by weight in the final product. The applicant shall provide a signed declaration of compliance supported by declarations from suppliers, if appropriate, or SDS confirming that none of these substances meets the criteria for classification with one or more of the hazard statements listed in Table 2 in the form(s) and physical state(s) in which they are present in the product.
         For substances listed in Annexes IV and V to Regulation (EC) No 1907/2006, which are exempted from registration obligations under points (a) and (b) of Article 2(7) of that Regulation, a declaration to this effect by the applicant shall suffice to comply.
         The applicant shall provide a signed declaration of compliance supported by declarations from suppliers, if appropriate, or SDS confirming the presence of ingoing substances that fulfil the derogation conditions.
         (c)   Substances of very high concern (SVHCs)

         The final product shall not contain any ingoing substances that have been identified in accordance with the procedure described in Article 59(1) of Regulation (EC) No 1907/2006, which establishes the candidate list for substances of very high concern.

            Assessment and verification: the applicant shall provide a signed declaration of compliance supported by declarations from their suppliers, if appropriate, or SDS confirming the non-presence of all the candidate list substances.
         Reference to the latest list of substances of very high concern shall be made on the date of application.
         (d)   Fragrances

         Any ingoing substance added to the product as a fragrance shall be manufactured and handled following the code of practice of the International Fragrance Association (IFRA) available at http://www.ifraorg.org (5). The recommendations of the IFRA Standards concerning prohibition, restricted use and specified purity criteria for substances shall be followed by the manufacturer.

            Assessment and verification: the supplier or fragrance manufacturer, as appropriate, shall provide a signed declaration of compliance.
         (e)   Preservatives

                     (i)

                     The product may only include preservatives in order to preserve the product, and in the appropriate dosage for this purpose alone. This does not refer to surfactants which may also have biocidal properties.

                     (ii)

                     The product may contain preservatives provided that they are not bio-accumulating. A preservative is considered to be not bio-accumulating if the BCF is < 100 or log Kow is < 3,0. If both the BCF and log Kow values are available, the highest measured BCF value shall be used.

                     (iii)

                     It is prohibited to claim or suggest on the packaging or by any other communication that the product has an antimicrobial or disinfecting effect.

            Assessment and verification: the applicant shall provide a signed declaration of compliance supported by declarations from suppliers, if appropriate, along with the SDS of any preservative added and information on its BCF or log Kow values. The applicant shall also provide artwork of the packaging.
         (f)   Colouring agents

         Colouring agents in the product shall not be bio-accumulating.
         A colouring agent is considered not bio-accumulating if the BCF is < 100 or log Kow is < 3,0. If both the BCF and log Kow values are available, the highest measured BCF value shall be used. In the case of colouring agents approved for use in food, it is not necessary to submit documentation of bio-accumulation potential.

            Assessment and verification: the applicant shall provide a signed declaration of compliance supported by declarations from suppliers, if appropriate, along with the SDS of any colouring agent added and information on its BCF or log Kow value, or documentation to ensure that the colouring agent is approved for use in food.
         (g)   Enzymes

         Only enzyme encapsulated (in solid form) and enzyme liquids/slurries shall be used.

            Assessment and verification: the applicant shall provide a signed declaration of compliance supported by declarations from suppliers, if appropriate, along with the SDS of any enzyme added.

            Criterion 5 — Packaging

         (a)   Packaging take-back systems

         If the product is delivered in packaging that is part of a take-back system, that product is exempted from the requirements set out in points (b) and (c) of Criterion 5

            Assessment and verification: the applicant shall provide a signed declaration of compliance along with relevant documentation describing or demonstrating that a take-back system has been put in place for the packaging.
         (b)   Weight/utility ratio (WUR)

         The weight/utility ratio (WUR) of the product shall be calculated for the primary packaging only and shall not exceed the following values for the reference dosage.

                     Water hardness
                     Product type

                     Soft
                     < 1,5 mmol CaCO3/l
                     (g/kg of laundry)

                     Medium
                     1,5-2,5 mmol CaCO3/l
                     (g/kg of laundry)

                     Hard
                     > 2,5 mmol CaCO3/l
                     (g/kg of laundry)

                     Powders

                     1,5

                     2,0

                     2,5

                     Liquids

                     2,0

                     2,5

                     3,0

               Primary packaging made of more than 80 % of recycled materials is exempted from this requirement.

            Assessment and verification: the applicant shall provide the calculation of the WUR of the product. If the product is sold in different packaging (i.e. with different volumes), the calculation shall be submitted for each packaging size for which the EU Ecolabel shall be awarded.
         The WUR is calculated as follows:

            WUR = Σ ((Wi
             + Ui
            )/(Di
             * Ri
            ))
         Where:

                     Wi

                     :

                     weight (g) of the primary packaging (i);

                     Ui

                     :

                     weight (g) of non-post-consumer recycled packaging in the primary packaging (i). Ui = Wi unless the applicant can document otherwise;

                     Di

                     :

                     number of reference doses contained in the primary packaging (i);

                     Ri

                     :

                     refill index. Ri = 1 (packaging is not reused for the same purpose) or Ri = 2 (if the applicant can document that the packaging component can be reused for the same purpose and they sell refills).

               The applicant shall provide a signed declaration of compliance confirming the content of post-consumer recycled material, along with relevant documentation. Packaging is regarded as post-consumer recycled if the raw material used to make the packaging has been collected from packaging manufacturers at the distribution stage or at the consumer stage.
         (c)   Design for recycling

         Plastic packaging shall be designed to facilitate effective recycling by avoiding potential contaminants and incompatible materials that are known to impede separation or reprocessing or to reduce the quality of recyclate. The label or sleeve, closure and, where applicable, barrier coatings shall not comprise, either singularly or in combination the materials and components listed in Table 4. Pump mechanisms (including in sprays) are exempted from this requirement.

            Table 4

            Materials and components excluded from packaging elements

                     Packaging element

                     Excluded materials and components (*4)

                     Label or sleeve

                                 —

                                 PS label or sleeve in combination with a PET, PP or HDPE bottle

                                 —

                                 PVC label or sleeve in combination with a PET, PP or HDPE bottle

                                 —

                                 PETG label or sleeve in combination with a PET bottle

                                 —

                                 Any other plastic materials for sleeves/labels with a density > 1 g/cm3 used with a PET bottle

                                 —

                                 Any other plastic materials for sleeves/labels with a density < 1 g/cm3 used with a PP or HDPE bottle

                                 —

                                 Labels or sleeves that are metallised or are welded to a packaging body (in mould labelling)

                     Closure

                                 —

                                 PS closure in combination a with a PET, HDPE or PP bottle

                                 —

                                 PVC closure in combination with a PET, PP or HDPE bottle

                                 —

                                 PETG closures or closure material with a density > 1 g/cm3 in combination with a PET bottle

                                 —

                                 Closures made of metal, glass, EVA which are not easily separable from the bottle

                                 —

                                 Closures made of silicone. Silicone closures with a density < 1 g/cm3 in combination with a PET bottle and silicone closures with a density > 1 g/cm3 in combination with PEHD or PP bottle are exempted.

                                 —

                                 Metallic foils or seals which remain fixed to the bottle or its closure after the product has been opened

                     Barrier coatings

                     Polyamide, functional polyolefins, metallised and light blocking barriers

            Assessment and verification: the applicant shall provide a signed declaration of compliance specifying the material composition of the packaging including the container, label or sleeve, adhesives, closure and barrier coating, as appropriate, along with photos or technical drawings of the primary packaging.

            Criterion 6 — Fitness for use

         The product shall have a satisfactory wash performance at the lowest temperature and dosage recommended by the manufacturer for the water hardness in accordance with the ‘Framework for performance testing for industrial and institutional laundry detergents’ available on the EU Ecolabel website (6).

            Assessment and verification: the applicant shall provide documentation demonstrating that the product has been tested under the conditions specified in the framework and that the results showed that the product achieved at least the minimum wash performance required. The applicant shall also provide documentation demonstrating compliance with the laboratory requirements included in the relevant harmonised standards for testing and calibration laboratories, if appropriate.
         An equivalent test performance may be used if equivalence has been assessed and accepted by the competent body.

            Criterion 7 — Automatic dosing systems

         For multi-component systems, the applicant shall ensure that the product is used with an automatic and controlled dosing system.
         In order to ensure correct dosage in the automatic dosing systems, customer visits shall be performed at all premises using the product, at least once a year during the license period, and they shall include calibration of the dosing equipment. A third party can perform these customer visits.

            Assessment and verification: the applicant shall provide a signed declaration of compliance along with a description of the content of customer visits, who is responsible for them and their frequency.

            Criterion 8 — User information

         The product shall be accompanied by instructions for proper use so as to maximise product performance and minimise waste, and reduce water pollution and use of resources. These instructions shall be legible or include graphical representation or icons and include information on the following:

                     (a)

                        Dosing instructions

                     Dosage instructions shall include the dose in g or ml and/or a second or alternative metric (e.g. caps, spray actuations) and the impact of the water hardness on the dose.
                     This requirement does not apply for multi-component products to be dosed with an automatic dosing system
                     Indications of the most prevalent water hardness in the area where the product is intended to be marketed or where this information can be found shall be provided.

                     (b)

                        Packaging disposal information

                     The primary packaging shall include information on the reuse, recycling and correct disposal of packaging.

                     (c)

                        Environmental information

                     A text shall appear on the primary packaging indicating the importance of using the correct dosage and the lowest recommended temperature in order to minimise energy and water consumption and reduce water pollution.
                     If the final product contains peracetic acid and hydrogen peroxide as a bleaching agent and is classified and labelled, a text shall appear on the primary packaging or technical product sheet stating that the classification and labelling is due to peracetic acid and hydrogen peroxide which degrade into non-classified substances during the washing process.

            Assessment and verification: the applicant shall provide a signed declaration of compliance along with a sample of the product label.

            Criterion 9 — Information appearing on the EU Ecolabel

         The logo should be visible and legible. The EU Ecolabel registration/licence number shall appear on the product and it shall be legible and clearly visible.
         The applicant may choose to include an optional text box on the label that contains the following text:

                     —

                     Limited impact on the aquatic environment (not to be included if the product contains peracetic acid and hydrogen peroxide which triggers final product classification and labelling);

                     —

                     Restricted amount of hazardous substances;

                     —

                     Tested for wash performance.

            Assessment and verification: the applicant shall provide a signed declaration of compliance along with a sample of the product label or artwork of the packaging where the EU Ecolabel is placed.

            (1)  Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).

            (2)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

            (*1)  ‘no limit’ means: regardless of the concentration, all substances intentionally added, by-products and impurities from raw materials (analytical limit of detection).

               N/A
             not applicable.

            (3)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

            (4)  A substance is considered to be not bio-accumulating if the BCF is < 100 or log Kow is < 3,0. If both the BCF and log Kow values are available, the highest measured BCF value shall be used.

            (*2)  Including stabilisers and other auxiliary substances in the preparations.

            (*3)  In concentrations lower than 0,2 % in the raw material as long as the total concentration in the final product is lower than 0,10 %.

            (5)  Available at the IFRA website: http://www.ifraorg.org

            (*4)  EVA — Ethylene Vinyl Acetate, HDPE — High-density polyethylene, PET — Polyethylene terephtalate, PETG — Polyethylene terephthalate glycol-modified, PP — Polypropylene, PS — Polystyrene, PVC — Polyvinylchloride.

            (6)  Available at: [URL for protocol on EU Ecolabel website will be inserted later currently all proposed protocol documents can be found in the Technical Report]


title: 2013/570/EU: Decision of the European Parliament of 17 April 2013 on discharge in respect of the implementation of the budget of the European Chemicals Agency for the financial year 2011

text:
               16.11.2013

               EN

               Official Journal of the European Union

               L 308/209

      DECISION OF THE EUROPEAN PARLIAMENT

   of 17 April 2013
   on discharge in respect of the implementation of the budget of the European Chemicals Agency for the financial year 2011
   (2013/570/EU)
   THE EUROPEAN PARLIAMENT,

               —

               having regard to the final annual accounts of the European Chemicals Agency for the financial year 2011,

               —

               having regard to the Court of Auditors’ report on the annual accounts of the European Chemicals Agency for the financial year 2011, together with the Agency’s replies (1),

               —

               having regard to the Council’s recommendation of 12 February 2013 (05753/2013 – C7-0041/2013),

               —

               having regard to Article 319 of the Treaty on the Functioning of the European Union,

               —

               having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

               —

               having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (3), and in particular Article 208 thereof,

               —

               having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4) establishing a European Chemicals Agency, and in particular Article 97 thereof,

               —

               having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (5), and in particular Article 94 thereof,

               —

               having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

               —

               having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0097/2013),

               1.

               Grants the Executive Director of the European Chemicals Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2011;

               2.

               Sets out its observations in the resolution below;

               3.

               Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Executive Director of the European Chemicals Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

            The President

         Martin SCHULZ

            The Secretary-General

         Klaus WELLE

      (1)  OJ C 388, 15.12.2012, p. 73.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 298, 26.10.2012, p. 1.

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

      (5)  OJ L 357, 31.12.2002, p. 72.

         RESOLUTION OF THE EUROPEAN PARLIAMENT

      of 17 April 2013
      with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Chemicals Agency for the financial year 2011
      THE EUROPEAN PARLIAMENT,

                  —

                  having regard to the final annual accounts of the European Chemicals Agency for the financial year 2011,

                  —

                  having regard to the Court of Auditors’ report on the annual accounts of the European Chemicals Agency for the financial year 2011, together with the Agency’s replies (1),

                  —

                  having regard to the Council’s recommendation of 12 February 2013 (05753/2013 – C7-0041/2013),

                  —

                  having regard to Article 319 of the Treaty on the Functioning of the European Union,

                  —

                  having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

                  —

                  having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (3), and in particular Article 208 thereof,

                  —

                  having regard to Regulation (EC) No 1907/2006 (4) of the European Parliament and of the Council establishing a European Chemicals Agency, and in particular Article 97 thereof,

                  —

                  having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (5), and in particular Article 94 thereof,

                  —

                  having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

                  —

                  having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0097/2013),

                  A.

                  whereas the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts of the European Chemicals Agency (‘the Agency’) for the financial year 2011 are reliable and that the underlying transactions are legal and regular,

                  B.

                  whereas on 10 May 2012, Parliament granted the Executive Director of the Agency discharge for implementation of the Agency’s budget for the financial year 2010 (6), and in its resolution accompanying the discharge decision, inter alia:

                              —

                              underlined that as the Agency works with non-dissociated credits in all its Titles, it is unrealistic to expect that all operations budgeted for one calendar year could both be committed and paid up within the same budgetary year, especially for project-type operational expenditure (e.g. IT systems developments),

                              —

                              called on the Agency to improve the planning of its human resources activities and projects at the time of establishing its Annual Work Programme,

                              —

                              welcomed the establishment by the Agency of a separate registration and submission unit, as well as a contingency task force,

                              —

                              called on the Agency to respect a stringent top down/bottom up methodology for reporting and clear guiding principles in order to define the relevant indicators and tools to be used,

                  C.

                  whereas according to the Court of Auditors’ report, the Agency’s overall budget for the financial year 2011 was of EUR 93 200 000 compared to EUR 75 500 000 in 2010, which represents an increase of 23,44 %,

                  D.

                  whereas during the financial year 2011, the Agency operated as a self-financed agency and did not receive any reimbursable subsidy from the Commission,

         Budgetary and financial management

                  1.

                  Acknowledges from the Agency’s 2011 annual activity report (AAR), that in accordance with Regulation (EC) No 1907/2006, the Agency is financed through fees paid by industry for registrations of chemical substances, and possibly by Union subsidy as referred to in Article 185 of the Financial Regulation;

                  2.

                  Takes note that in 2011, the Agency was effectively fully financed through fee income and did not receive any Union subsidy; notes, however, that the Agency was supported by the Union with an amount of only EUR 500 000 from the Commission (Directorate-General Environment) as contractual compensation for undertaking certain preparatory activities for the upcoming Regulation (EU) No 528/2012 of the European Parliament and of the Council (7) on biocidal products;

                  3.

                  Notes that the initial budgetary payment appropriations for 2011, as concluded by the Management Board in December 2010, amounted to EUR 99 800 000;

                  4.

                  Notes from the AAR that in 2010, the Agency received a balancing subsidy of EUR 36 000 000 registered as a pre-financing liability from the Commission; notes, moreover, that the amount was entirely reimbursed to the Commission in 2011 as the foreseen high level of own fee income of the Agency in 2011 was reached;

                  5.

                  Acknowledges that in 2011, the Management Board adopted two amending budgets, as follows:

                              —

                              the first amending budget increased the revenue with the surplus resulting from 2010 by EUR 280 565 807,25; notes that it also entered the amount of EUR 500 000 on earmarked revenue for the service contract established between the Agency and DG Environment for the preparatory work for Regulation (EU) No 528/2012;

                              —

                              the second amending budget decreased the budget expenditure by EUR 7 142 500 (7 %);

                  6.

                  Observes from the AAR that the budget execution rate for 2011 was 96 %;

         Commitments and payments

                  7.

                  Acknowledges from the AAR that the total amount of carry-over of commitment and payment appropriations was of EUR 14 421 314,76, representing 16,2 % of the established commitments; calls on the Agency to inform the discharge authority of the actions taken to address that deficiency as the level of carry-over is excessive and at odds with the budgetary principle of annuality;

                  8.

                  Takes note from the AAR that the adopted budget for Title I in 2011(EUR 54 508 000) was increased via transfers from Title III by 4,25 % (EUR 2 316 781,90), out of which EUR 2 005 138,33 was related to expenditure for staffing; notes, moreover, that as a result, the execution rate for Title I reached 99,16 %;

                  9.

                  Notes that a total amount of EUR 1 758 060,98 was cancelled from the total amount of EUR 12 254 740,59 of commitment and payment appropriations that were carried over from the budget of 2010;

                  10.

                  Welcomes the Agency’s efforts in improving the planning and the monitoring of resources and the fact that it introduced Agency-wide guidelines to foster the principle of annuality; acknowledges, in particular, that the Agency managed to reduce the carry-over rate from 29 % in 2009 to 17 % in 2010 and to 16,2 % in 2011;

         Supervisory and control systems

                  11.

                  Acknowledges from the Court of Auditors’ report that the results of the latest physical inventory carried out in 2011 show several shortcomings, notably as regards the low proportion of Information and Communication Technology (ICT) assets checked in terms of value; notes, moreover, that no formal policy on the inventory of fixed assets is in place; calls on the Agency to inform the discharge authority of the actions taken to implement a formal policy on the inventory of fixed assets;

                  12.

                  Notes that the Agency records costs related to ICT projects that are already in use as expenditure instead of recognising them as fixed assets; notes furthermore that the policy is expected to be formalised and formally approved in the first quarter of 2013; calls on the Agency to inform the discharge authority of the state of play of that policy;

         Recruitment procedures

                  13.

                  Notes that the Court of Auditors identified shortcomings in the recruitment procedures; calls, therefore, on the Agency to inform the discharge authority of the actions taken to address that deficiency; considers that some of the provisions of the Staff Regulations may present a considerable administrative burden; therefore encourages the Commission to allow for a certain degree of simplification under Article 110 of the Staff Regulations in regard to the agencies;

                  14.

                  Notes from the AAR that the Agency continued to attract highly qualified personnel, with 88 new staff recruited in 2011, which resulted in the completion of 98 % of the Agency’s establishment plan;

                  15.

                  Acknowledges that as of 31 December 2011, the total number of positions occupied by temporary agents positions was 441 out of 456 available posts and 101 contract agents and seconded national experts were employed by the end of 2011; notes that the total number of positions occupied by contract agents was 62 and the total number of other staff was 46 (seconded national experts, interims, trainees);

                  16.

                  Monitors closely the improved recruitment and selection procedures which have been put into place in the last year; considers the full application of rules and procedures a necessity to ensure the best reputation of the Agency;

         Conflict of interest

                  17.

                  Welcomes the fact that the Court of Auditors carried out an audit aimed at evaluating the policies and procedures for the management of conflict of interest situations for four European agencies, including the Agency, and presented the results of the audit in the Court of Auditors’ Special Report No 15/2012;

                  18.

                  Regrets that according to the findings of the Court of Auditors, at the time of completion of the field work (October 2011), the Agency did not adequately manage situations involving conflicts of interest; notes, moreover, that the Agency’s policies for managing conflict of interest were incomplete, declarations of interest were neither screened nor published but sealed and training on conflict of interest was absent;

                  19.

                  Welcomes the fact that the Agency is to take a number of steps following the Court of Auditors’ audit, in particular:

                              —

                              an Agency policy for the management of potential conflicts of interest, adopted in September 2011,

                              —

                              a new, more detailed template for declarations of interest,

                              —

                              a new guidance for filling in declarations of interests, adopted in November 2011,

                              —

                              publication of declarations of interest of the Agency’s managers on its website since January 2012,

                              —

                              conflicts of interest advisory committee established in June 2012, with a constituent meeting in August 2012,

                              —

                              a code of conduct for the Management Board members, adopted in March 2012,

                              —

                              provisional eligibility criteria for the bodies of the Agency, adopted in September 2012,

                              —

                              implementing rules on prevention of conflicts of interest and on processing information on potential conflicts of interest of the Agency staff, adopted in June 2012 and October 2012 respectively,

                              —

                              guidance for managers on the prevention of conflicts of interest, including concrete assessment criteria, adopted in November 2012,

                              —

                              revised guidelines on gifts and hospitality for staff, adopted in December 2012;

                        urges the Agency to continue to act on the recommendations made by the Court of Auditors in order to avoid any conflict of interests among its various governing and operational structures and to report to the discharge authority on the implementation of the abovementioned policies and procedures, as well as on any further developments as regards management of conflict of interest;

                  20.

                  Calls on the Agency to introduce in its annual activity reports a special section describing the actions taken to prevent and manage conflicts of interest, which shall include, inter alia:

                              —

                              the number of conflicts of interest cases verified,

                              —

                              the number of revolving door cases,

                              —

                              the measures taken in each category of cases,

                              —

                              the number of breach of trust procedures launched and their outcomes,

                              —

                              the sanctions applied;

                  21.

                  Points out that all Management Board members’ declarations of interest are available on the Agency’s website, yet not all curriculum vitae of the Management Board members are available; calls on the Agency to inform the discharge authority of the progress made on this matter as soon as possible;

                  22.

                  Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its Resolution of 17 April 2013 (8) on the performance, financial management and control of the agencies.

         (1)  OJ C 388, 15.12.2012, p. 73.

         (2)  OJ L 248, 16.9.2002, p. 1.

         (3)  OJ L 298, 26.10.2012, p. 1.

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

         (5)  OJ L 357, 31.12.2002, p. 72.

         (6)  OJ L 286, 17.10.2012, p. 192.

         (7)  OJ L 167, 27.6.2012, p. 1.

         (8)  Texts adopted, P7_TA(2013)0134 (See page 374 of this Official Journal).


Important legal notice

|

32004D0218

2004/218/EC: Council Decision of 19 February 2004 appointing an Austrian member of the Committee of the Regions

Official Journal L 068 , 06/03/2004 P. 0020 - 0020

Council Decisionof 19 February 2004appointing an Austrian member of the Committee of the Regions(2004/218/EC)THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 263 thereof,Having regard to the proposal from the Austrian Government,Whereas:(1) On 22 January 2002 the Council adopted a Decision appointing the members and alternate members of the Committee of the Regions(1).(2) A seat as a member of the Committee of the Regions has become vacant following the resignation of Ms Helga MACHNE, notified to the Council on 26 January 2004,HAS DECIDED AS FOLLOWS:Sole ArticleMr Bernd VÖGERLE, Bürgermeister, Vizepräsident des Österreichischen Gemeindebundes and alternate member of the Committee of the Regions, is hereby appointed a member of the Committee of the Regions in place of Ms Helga MACHNE for the remainder of her term of office, which runs until 25 January 2006.Done at Brussels, 19 February 2004.For the CouncilThe PresidentM. McDowell(1) OJ L 24, 26.1.2002, p. 38.


title: Political and Security Committee Decision (CFSP) 2015/317 of 24 February 2015 on the acceptance of a third State's contribution to the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) (ATALANTA/2/2015)

text:
               27.2.2015

               EN

               Official Journal of the European Union

               L 56/75

         POLITICAL AND SECURITY COMMITTEE DECISION (CFSP) 2015/317
   of 24 February 2015
   on the acceptance of a third State's contribution to the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) (ATALANTA/2/2015)
   THE POLITICAL AND SECURITY COMMITTEE,
   Having regard to the Treaty on European Union, and in particular the third paragraph of Article 38 thereof,
   Having regard to Council Joint Action 2008/851/CFSP of 10 November 2008 on a European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (1), and in particular Article 10 thereof,
   Having regard to the Political and Security Committee Decision ATALANTA/3/2009 of 21 April 2009 on the setting up of the Committee of Contributors for the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) (2009/369/CFSP) (2),
   Whereas:

               (1)

               Pursuant to Article 10(2) of Joint Action 2008/851/CFSP, the Council authorised the Political and Security Committee (PSC) to take the relevant decisions on acceptance of the proposed contributions by third States.

               (2)

               On 29 April 2014 the PSC adopted Decision Atalanta/2/2014 (3) which amended Decision ATALANTA/3/2009.

               (3)

               Following the recommendation on a contribution from Colombia by the EU Operation Commander on 24 October 2014 and the advice from the European Union Military Committee on 22 January 2015, the contribution from Colombia should be accepted.

               (4)

               The participation of Colombia is subject to the entry into force of the Agreement between the European Union and the Republic of Colombia establishing a framework for the participation of the Republic of Colombia in European Union crisis management operations (4), signed on 5 August 2014.

               (5)

               In accordance with Article 5 of Protocol No 22 on the position of Denmark, annexed to the Treaty on the European Union and to the Treaty on the Functioning of the European Union, Denmark does not participate in the elaboration and implementation of decisions and actions of the Union which have defence implications,

         HAS ADOPTED THIS DECISION:
   Article 1
   1.   The contribution from Colombia to the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) is accepted and is considered to be significant.
   2.   Colombia is exempted from financial contributions to the budget of Atalanta.
   Article 2
   This Decision shall enter into force on the date of its adoption.

      Done at Brussels, 24 February 2015.

            For the Political and Security Committee

            The Chairperson

         W. STEVENS

      (1)  OJ L 301, 12.11.2008, p. 33.

      (2)  OJ L 112, 6.5.2009, p. 9.

      (3)  Political and Security Committee Decision Atalanta/2/2014 of 29 April 2014 on the acceptance of a third State's contribution to the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) and amending Decision ATALANTA/3/2009 (2014/244/CFSP) (OJ L 132, 3.5.2014, p. 63).

      (4)  OJ L 251, 23.8.2014, p. 8.


Avis juridique important

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31999D0123

1999/123/EC: Commission Decision of 9 February 1999 ceasing registration of television camera systems' modules, kits, sub-assemblies and parts thereof and terminating the investigation concerning the alleged circumvention of anti-dumping measures imposed by Council Regulation (EC) No 1015/94, on imports of certain television camera systems originating in Japan (notified under document number C(1999) 276)

Official Journal L 038 , 12/02/1999 P. 0056 - 0057

COMMISSION DECISION of 9 February 1999 ceasing registration of television camera systems' modules, kits, sub-assemblies and parts thereof and terminating the investigation concerning the alleged circumvention of anti-dumping measures imposed by Council Regulation (EC) No 1015/94, on imports of certain television camera systems originating in Japan (notified under document number C(1999) 276) (1999/123/EC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Regulation (EC) No 384/96 of 22 December 1995 on protection against dumped imports from countries not members of the European Community (1), as last amended by Regulation (EC) No 905/98 (2), and in particular Article 9 thereof,After consulting the Advisory Committee,Whereas:A. PROCEDURE (1) On 18 March 1998, the Commission received a complaint concerning the alleged circumvention of definitive anti-dumping duties imposed by Council Regulation (CE) No 1015/94 (3), as last amended by Regulation (EC) No 1952/97 (4) on television camera systems (hereinafter referred to as TCS) originating in Japan, by imports of TCS modules, kits, sub-assemblies and parts originating in Japan used for the assembly of complete TCS in the Community.(2) The complaint was lodged by Philips Broadcast Television Systems Bv, Community producer of TCS representing a major proportion of the total Community production of the product concerned pursuant to Article 4(1) and Article 5(4) of Regulation (EC) No 384/96 (hereinafter referred to as the 'Basic Regulation`).(3) The complaint contained evidence of circumvention concerning two producers/exporters, namely Ikegami Tsushinki Co. Ltd (hereinafter referred to as Ikegami/Japan) and Sony Corporation (hereinafter referred to as Sony/Japan), by assembly/completion operations of their related importers in the European Community. There was no prima facie evidence of assembly/completion operations of other Japanese exporters/producers. No other company made itself known to the Commission during the investigation.(4) The Commission, after consultation, by Regulation (EC) No 1178/98 published in the Official Journal of the European Communities (5) initiated an investigation concerning the alleged circumvention of definitive anti-dumping duties imposed by the abovementioned Council Regulation on TCS originating in Japan by imports of TCS modules, kits, sub-assemblies and parts thereof originating in Japan and currently classifiable within the following CN-codes: ex 8504 31 90, ex 8525 30 90, ex 8529 90 72, ex 8529 90 81, ex 8529 90 88, ex 8536 90 10, ex 8538 90 99, ex 8542 13 72, ex 8531 20 59, ex 8531 20 80, ex 8538 10 00, ex 8538 90 91 and ex 9002 90 90.(5) The Commission also directed custom authorities, pursuant to Article 14(5) of the Basic Regulation, to register imports of the abovementioned parts.(6) The Commission officially advised the exporting producers and importers concerned, the representatives of the exporting country and the complainant Community producer of the initiation of the investigation. Interested parties were given the opportunity to make their views known in writing and to request a hearing within the time limits set out in the Regulation initiating the proceeding.B. WITHDRAWAL OF THE COMPLAINT AND TERMINATION OF THE PROCEEDING (7) By letter of 17 December 1998 to the Commission, Philips Broadcast Television Systems Bv formally withdrew its complaint.(8) In accordance with Article 9(1) of the Basic Regulation, when the complainant withdraws its complaint the proceeding may be terminated unless such termination would not be in the Community interest.(9) The Commission considered that the present proceeding should be terminated since the investigation had not brought to light any considerations showing that such termination would not be in the Community interest. Interested parties were informed accordingly and were given opportunity to comment. No comments were received indicating that such termination would not be in the Community interest.(10) The Commission therefore concludes that the present proceeding concerning the alleged circumvention of definitive anti-dumping duties in force imposed on TCS originating in Japan by imports of TCS modules, kits, sub-assemblies and parts thereof originating in Japan should be terminated without imposition of protective measures. Consequently, the registration of the parts concerned should be ceased,HAS DECIDED AS FOLLOWS:Article 1 The investigation concerning the circumvention of the anti-dumping duties imposed by Regulation (EC) No 1015/94 on imports of television camera systems originating in Japan by imports of television camera systems modules, kits, sub-assemblies and parts thereof originating in Japan and currently classifiable within the CN-codes ex 8504 31 90, ex 8525 30 90, ex 8529 90 72, ex 8529 90 81, ex 8529 90 88, ex 8536 90 10, ex 8538 90 99, ex 8542 13 72, ex 8531 20 59, ex 8531 20 80, ex 8538 10 00, ex 8538 90 91 and ex 9002 90 90, initiated by Regulation (EC) No 1178/98, is hereby terminated.Article 2 Regulation (EC) No 1178/98 is hereby repealed.Done at Brussels, 9 February 1999.For the CommissionLeon BRITTANVice-President(1) OJ L 56, 6. 3. 1996, p. 1.(2) OJ L 128, 30. 4. 1998, p. 18.(3) OJ L 111, 30. 4. 1994, p. 106.(4) OJ L 276, 9. 10. 1997, p. 20.(5) OJ L 163, 6. 6. 1998, p. 20.


title: Commission Decision of 28 June 2013 appointing members and alternates of the Committee for Advanced Therapies to represent clinicians and patients' associations  Text with EEA relevance

text:
               29.6.2013

               EN

               Official Journal of the European Union

               C 187/9

         COMMISSION DECISION
   of 28 June 2013
   appointing members and alternates of the Committee for Advanced Therapies to represent clinicians and patients' associations
   (Text with EEA relevance)
   2013/C 187/08
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 726/2004 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 21(1) thereof,
   Whereas:

               (1)

               Regulation (EC) No 1394/2007 lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products. Article 20 of that Regulation lays down that a Committee for Advanced Therapies shall be established within the European Medicines Agency.

               (2)

               Subparagraph (c) of Article 21(1) of Regulation (EC) No 1394/2007 lays down that the Committee for Advanced Therapies shall include two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent clinicians.

               (3)

               Subparagraph (d) of Article 21(1) of Regulation (EC) No 1394/2007 lays down that the Committee for Advanced Therapies shall include two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent patients' associations.

               (4)

               In accordance with Article 21(3) of Regulation (EC) No 1394/2007, the members and alternates of the Committee for Advanced Therapies are appointed for a period of 3 years. The term of office of the members and alternates appointed in 2009 has expired and therefore a new call has been undertaken in 2012.

               (5)

               In accordance with Article 21(1) of Regulation (EC) No 1394/2007, a public call for expression of interest has been undertaken by the Commission. The European Parliament has been consulted on the results of the evaluation of the applications received,

         HAS ADOPTED THIS DECISION:
   Article 1
   The following are hereby appointed members and alternates of the Committee for Advanced Therapies to represent clinicians for a term of 3 years, from 1 July 2013:

               —

               Pieter DOEVENDANS (Member) and Esteve TRIAS (Alternate),

               —

               Bernd GÄNSBACHER (Member) and Ramadan JASHARI (Alternate).

         Article 2
   The following are hereby appointed members and alternates of the Committee for Advanced Therapies to represent patients' associations for a term of 3 years, from 1 July 2013:

               —

               Michele LIPUCCI DI PAOLA (Member) and Monica ENSINI (Alternate),

               —

               Kieran BREEN (Member) and Mariette DRIESSENS (Alternate).

      Done at Brussels, 28 June 2013.

            For the Commission

         Tonio BORG

            Member of the Commission

      (1)  OJ L 136, 30.4.2004, p. 1.


Avis juridique important

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32003D0254

2003/254/EC: Council Decision of 19 December 2002 on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the United States of America relating to the modification of concessions with respect to cereals provided for in EC Schedule CXL to the GATT 1994

Official Journal L 095 , 11/04/2003 P. 0040 - 0044

Council Decisionof 19 December 2002on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the United States of America relating to the modification of concessions with respect to cereals provided for in EC Schedule CXL to the GATT 1994(2003/254/EC)THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 133 in conjunction with the first sentence of the first subparagraph of Article 300(2) thereof,Having regard to the proposal from the Commission,Whereas:(1) On 26 July 2002, the Council authorised the Commission to open negotiations under Article XXVIII of the GATT 1994 with a view to modifying certain concessions for cereals. Accordingly, the European Community notified the WTO on 26 July 2002 of its intention to modify certain concessions in EC Schedule CXL.(2) Negotiations have been conducted by the Commission in consultation with the Committee established by Article 133 of the Treaty and within the framework of the negotiating directives issued by the Council.(3) The Commission has negotiated, with the United States of America, the WTO Member having a substantial supplying interest, an Agreement in the form of an Exchange of Letters.(4) The Agreement in the form of an Exchange of Letters between the European Community and the United States of America should therefore be approved.(5) In order to ensure that the Agreement may be fully applied by 1 January 2003 and pending the amendment of Council Regulation (EEC) No 1766/92 of 30 June 1992 on the common organisation of the market in cereals(1), the Commission should be authorised to adopt temporary derogations from that Regulation.(6) The measures necessary for the implementation of this Decision should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(2),HAS DECIDED AS FOLLOWS:Article 1The Agreement in the form of an Exchange of Letters between the European Community and the United States of America relating to the modification of concessions with respect to cereals provided for in EC Schedule CXL annexed to the GATT 1994 is hereby approved on behalf of the Community.The text of the Agreement is attached to this Decision.Article 2To the extent necessary to permit the full application of this Agreement by 1 January 2003, the Commission may derogate from Regulation (EEC) No 1766/92, in accordance with the procedure referred to in Article 3(2) of this Decision, until that Regulation is amended but not later than 30 June 2003.Article 31. The Commission shall be assisted by the Management Committee for Cereals instituted by Article 23 of Regulation (EEC) No 1766/92.2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply.The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.3. The Committee shall adopt its rules of procedure.Article 4The President of the Council is hereby authorised to designate the person empowered to sign the Agreement in order to bind the Community.Done at Brussels, 19 December 2002.For the CouncilThe PresidentM. Fischer Boel(1) OJ L 181, 1.7.1992, p. 21. Regulation as last amended by Regulation (EC) No 1666/2000 (OJ L 193, 29.7.2000, p. 1).(2) OJ L 184, 17.7.1999, p. 23.