14.6.2017   

EN

Official Journal of the European Union

L 150/1

(1)

Annex III to Directive 2008/98/EC lists properties of waste which render it hazardous.

(2)

Directive 2008/98/EC states that the classification of waste as hazardous should be based, inter alia, on the Union legislation on chemicals, in particular concerning the classification of mixtures as hazardous, including concentration limit values used for that purpose. Commission Decision 2000/532/EC (2) established a list of the types of waste in order to encourage a harmonised classification of waste and to ensure the harmonised determination of hazardous properties of waste within the Union.

(3)

Annex III to Directive 2008/98/EC provides that the attribution of the hazardous property HP 14 ‘Ecotoxic’ is to be made on the basis of the criteria laid down in Annex VI to Council Directive 67/548/EEC (3).

(4)

Directive 67/548/EEC was repealed with effect from 1 June 2015 and replaced by Regulation (EC) No 1272/2008 of the European Parliament and of the Council (4). That Directive may, however, continue to apply to some mixtures until 1 June 2017, in case they were classified, labelled and packaged in accordance with Directive 1999/45/EC of the European Parliament and of the Council (5) and already placed on the market before 1 June 2015.

(5)

Annex III to Directive 2008/98/EC was replaced by Commission Regulation (EU) No 1357/2014 (6) in order to align, where appropriate, the definitions of hazardous properties with Regulation (EC) No 1272/2008, and replace references to Directive 67/548/EEC by references to Regulation (EC) No 1272/2008.

(6)

The definition of the hazardous property HP 14 ‘Ecotoxic’ was not amended by Regulation (EU) No 1357/2014 as an additional study was needed in order to ensure completeness and representativeness as regards information on the possible impact of an alignment of the assessment of the hazardous property HP 14 ‘Ecotoxic’ with the criteria laid down in Regulation (EC) No 1272/2008. That study being completed, it is appropriate to reflect its recommendations in the assessment of hazardous property HP 14 ‘Ecotoxic’ for waste set out in Annex III to Directive 2008/98/EC, and to align that assessment, to the extent possible, with the criteria laid down in Regulation (EC) No 1272/2008 for the assessment of ecotoxicity of chemicals. When determining the hazard classification of waste for hazardous property HP 14 ‘Ecotoxic’ by applying calculation formulae, generic cut-off values, as defined in Regulation (EC) No 1272/2008, should be applied.

(7)

Annex VI to Regulation (EC) No 1272/2008 contains harmonised multiplying factors assigned to a limited number of substances classified as ‘hazardous to the aquatic environment, acute category 1’ or ‘hazardous to the aquatic environment, chronic category 1’, which are used to derive the classification of a mixture in which such substances are present. In light of progress made in establishing such multiplying factors, the Commission may, in accordance with Article 38(2) of Directive 2008/98/EC, review the calculation method for the assessment of substances with regard to the hazardous property HP 14 ‘Ecotoxic’ in view of the possible inclusion of multiplying factors in that method.

(8)

When a test is performed to assess waste for the hazardous property HP 14 ‘Ecotoxic’, it is appropriate to apply the relevant methods established in Commission Regulation (EC) No 440/2008 (7) or other internationally recognised test methods and guidelines. Decision 2000/532/EC provides that, where a hazardous property of waste has been assessed by a test and by using the concentrations of hazardous substances as indicated in Annex III to Directive 2008/98/EC, the results of the test are to prevail. Furthermore, Article 12 of Regulation (EC) No 1272/2008, in particular Article 12(b) and the methodologies for its application, should be taken into account. It is appropriate for the Commission to promote the exchange of best practices with regard to test methods for the assessment of substances as concerns the hazardous property HP 14 ‘Ecotoxic’ with a view to their possible harmonisation.

(9)

It is appropriate to allow companies and competent authorities sufficient time to adapt to the new requirements.

(10)

The Committee referred to in Article 39 of Directive 2008/98/EC did not deliver an opinion on the measures provided for in this Regulation. The measures should therefore be adopted by the Council in accordance with Article 5a(4) of Council Decision 1999/468/EC (8),

14.6.2017   

EN

Official Journal of the European Union

L 150/5

(1)

Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

(2)

On 7 June 2017, the Sanctions Committee of the United Nations Security Council decided to amend one entry in its list of persons, groups and entities to whom the freezing of funds and economic resources should apply. Annex I to Regulation (EC) No 881/2002 should therefore be amended accordingly,

14.6.2017   

EN

Official Journal of the European Union

L 150/7

(1)

The substance 1-bromopropane (n-propyl bromide) meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and the Council (2) and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.

(2)

The substance diisopentylphthalate meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.

(3)

The substance 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich, meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.

(4)

The substance 1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters, meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.

(5)

The substance 1,2-benzenedicarboxylic acid, dipentylester, branched and linear, meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.

(6)

The substance bis(2-methoxyethyl) phthalate meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.

(7)

The substance dipentylphthalate meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.

(8)

The substance N-pentyl-isopentylphthalate meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.

(9)

When containing a certain percentage of benzo[a]pyrene, the substance anthracene oil meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(a) of that Regulation. The substance is also persistent, bioaccumulative and toxic, as well as very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII to Regulation (EC) No 1907/2006 and therefore meets the criteria for inclusion in Annex XIV to that Regulation set out in Article 57(d) and (e) of that Regulation.

(10)

The substance pitch, coal tar, high temp. meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(a) of that Regulation. The substance is also persistent, bioccumulative and toxic, as well as very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII to Regulation (EC) No 1907/2006 and therefore meets the criteria for inclusion in Annex XIV to that Regulation set out in Article 57(d) and (e) of that Regulation.

(11)

The substance group 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and substances of unknown or variable composition, complex reaction products or biological materials (‘UVCB substances’), polymers and homologues) are substances which through their degradation have endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment. As such, they give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 of Regulation (EC) No 1907/2006 and, therefore, meet the criteria for inclusion in Annex XIV to that Regulation set out in Article 57(f) of that Regulation.

(12)

The substance group 4-nonylphenol, branched and linear, ethoxylated (including substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof), are substances which through their degradation have endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment. As such, they give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 of Regulation (EC) No 1907/2006 and, therefore, meet the criteria for inclusion in Annex XIV to that Regulation set out in Article 57(f) of that Regulation.

(13)

Those substances have been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006. They have furthermore been prioritised for inclusion in Annex XIV to Regulation (EC) No 1907/2006 by the European Chemicals Agency (‘the Agency’) in its recommendations of 6 February 2014 (3) and 1 July 2015 (4), in accordance with Article 58 of that Regulation. In addition, the Commission has received information on socioeconomic impacts provided in the numerous stakeholder submissions after receipt of the Agency's fifth recommendation or provided through a public consultation conducted in parallel with the Agency's public consultation on its draft sixth recommendation. Notwithstanding the information received, it is appropriate to include those substances in that Annex.

(14)

It is appropriate to indicate the dates referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006 in line with the Agency's recommendations of 6 February 2014 and of 1 July 2015. Those dates have been identified on the basis of the estimated time that would be required to prepare an application for the authorisation, taking into account the information available on the different substances and the information received during the public consultation carried out in accordance with Article 58(4) of Regulation (EC) No 1907/2006. To that purpose, the Agency's capacity to handle applications in the time provided for in Regulation (EC) No 1907/2006 should also been taken into account, as provided in Article 58(3) of that Regulation.

(15)

For each of those substances listed in the Annex to this Regulation there are no reasons why the date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006 should be set later than 18 months after the date referred to in Article 58(1)(c)(ii) of that Regulation.

(16)

Article 58(1)(e) in conjunction with Article 58(2) of Regulation (EC) No 1907/2006 provides for the possibility of exemptions of uses or categories of uses in cases where specific Union legislation imposes minimum requirements relating to the protection of human health or the environment ensuring proper control of the risks. In accordance with the information currently available it is not appropriate to set exemptions based on those provisions.

(17)

On the basis of the information currently available it is not appropriate to set exemptions for product and process orientated research and development.

(18)

On the basis of the information currently available it is not appropriate to set review periods for certain uses. In accordance with Article 60(8) of Regulation (EC) No 1907/2006 review periods are to be determined on a case-by-case basis taking into account, inter alia, the risks posed by the uses of the substance, the socioeconomic benefits arising from its use and the analysis of alternatives or any substitution plan submitted for uses for which authorisation is requested. In instances where there is no suitable alternative, the risks posed by the use are limited by appropriate and effective risk management measures, and when the benefits arising from the use are expected to be high, as could be the case for uses in the production of medicinal products or medical devices, review periods could be long.

(19)

In order to avoid the premature obsolescence of articles that are no longer produced after the sunset dates referred to Annex XIV to Regulation (EC) No 1907/2006, some substances (by themselves or in mixtures) included in that Annex need to be available for the production of spare parts for the repair of those articles, where those articles cannot function as intended without those spare parts, as well as where some Annex XIV substances (by themselves or in mixtures) are necessary for the repair of such articles. To that end, applications for authorisation for the use of an Annex XIV substance for the production of such spare parts and for the repair of such articles should be simplified. The transitional arrangements applicable to the substances concerned by those uses should be extended in order to allow for the adoption of implementing measures for such simplified applications for authorisation.

(20)

Regulation (EC) No 1907/2006 should therefore be amended accordingly.

(21)

N,N-Dimethylformamide (DMF) meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation. It has also been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006 and prioritised for inclusion in Annex XIV to that Regulation by the Agency's recommendation of 6 February 2014 in accordance with Article 58 of that Regulation. DMF has similar intrinsic properties to those of N,N-dimethylacetamide (DMAC) and N-methyl-2-pyrrolidone (NMP) and the three substances may be considered as potential alternatives for some of their major uses. NMP is the subject of an on-going restriction procedure in accordance with Article 69 of Regulation (EC) No 1907/2006. In view of the similarities of the three substances, both regarding their intrinsic properties and their industrial applications, and in order to ensure a consistent regulatory approach, the Commission considers it appropriate to postpone the decision on the inclusion of DMF in Annex XIV as has already been done for DMAC when the Commission considered the Agency's recommendation of 17 January 2013.

(22)

Diazene-1,2-dicarboxamide (C,C′-azodi(formamide)) (ADCA) meets the criteria for classification as a respiratory sensitiser (Resp. Sens.1). Taking into account all available information about the intrinsic properties of ADCA and about its adverse effects, the Agency concluded that it can be regarded as a substance for which there is scientific evidence of probable serious effects to human health which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 of Regulation (EC) No 1907/2006 and therefore meets the criteria for inclusion in Annex XIV to that Regulation set out in Article 57(f) of that Regulation. It has also been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006 and prioritised for inclusion in Annex XIV to that Regulation by the Agency's recommendation of 6 February 2014 in accordance with Article 58 of that Regulation. Uses of ADCA are very diverse and concern a broad range of different manufacturing industries, expected to lead to highly complex applications for authorisation. As currently the experience for handling authorisation applications covering broad ranges of uses is still limited, it is appropriate to postpone the decision on the inclusion of ADCA in Annex XIV, for the time being.

(23)

Certain aluminosilicate refractory ceramic fibres (Al-RCF) and zirconia aluminosilicate refractory ceramic fibres (Zr-RCF) meet the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meet the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(a) of that Regulation. They have also been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006 and prioritised for inclusion in Annex XIV to that Regulation by the Agency's recommendation of 6 February 2014 in accordance with Article 58 of that Regulation. The actual fibres are manufactured at a very limited number of industrial sites and are in general directly transformed within the same manufacturing process into articles that are subsequently used in a broad range of industrial equipment for high-temperature insulation, which can potentially lead to significant worker exposure. However, the use of articles made of the fibres is not subject to authorisation under Regulation (EC) No 1907/2006. In order to decide on the most relevant regulatory approach, the Commission considers it appropriate to postpone the decision on the inclusion of Al-RCF and Zr-RCF in Annex XIV to Regulation (EC) No 1907/2006 for the time being.

(24)

Boric acid, disodium tetraborate (anhydrous), diboron trioxide, and tetraboron disodium heptaoxide (hydrate) meet the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meet the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation. They have also been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006 and prioritised for inclusion in Annex XIV to that Regulation by the Agency's recommendation of 1 July 2015 in accordance with Article 58 of that Regulation. Furthermore, the uses of these substances are very diverse and concern a broad range of different manufacturing industries, expected to lead to highly complex applications for authorisation. As currently the experience for handling authorisation applications covering broad ranges of uses is still limited, it is appropriate to postpone the decision on the inclusion of these substances in Annex XIV for the time being.

(25)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

14.6.2017   

EN

Official Journal of the European Union

L 150/14

(1)

Perfluorooctanoic acid (‘PFOA’), its salts and PFOA-related substances (2) have some specific properties such as high friction resistance, dielectricality, resistance to heat and chemical agents, and low surface energy. They are used in a wide variety of applications such as in the fluoropolymer and fluoroelastomer production, as surfactants in fire-fighting foams, and in textile and paper production to provide water, grease, oil and/or dirt repellency.

(2)

On 14 June 2013, the Member State Committee, referred to in Article 76(1)(e) of Regulation (EC) No 1907/2006, identified PFOA as a persistent, bioaccumulative and toxic substance (‘PBT’) in accordance with Article 57(d) of that Regulation. On 20 June 2013, PFOA was included in the Candidate List of Substances of Very High Concern (‘SVHC’) for possible inclusion in Annex XIV to Regulation (EC) No 1907/2006.

(3)

On 17 October 2014, Germany and Norway submitted to the European Chemicals Agency (‘the Agency’) a dossier (3) pursuant to Article 69(4) of Regulation (EC) No 1907/2006 (‘the Annex XV dossier’), proposing to restrict the manufacture, placing on the market and use of PFOA, its salts and PFOA-related substances, in order to address the risks to human health and the environment. Germany and Norway proposed a concentration limit of 2 ppb for the presence of these substances in other substances, mixtures or articles, and did not propose exemptions except for second-hand articles for which an end-use in the Union can be demonstrated before the date of application of the restriction.

(4)

On 8 September 2015, the Agency's Committee for Risk Assessment (‘RAC’) adopted its opinion concluding that subject to modification of the scope and conditions proposed in the Annex XV dossier, a general restriction on manufacture, use and placing on the market of PFOA, its salts and PFOA-related substances, is the most appropriate Union-wide measure to address the identified risks in terms of effectiveness in reducing those risks. RAC proposed two different concentration limits, namely 25 ppb for PFOA and its salts and 1 000 ppb for one or a combination of PFOA-related substances, in other substances, mixtures or articles, reflecting the possible presence of unavoidable impurities and unintended contaminants, and taking account of the capabilities of analytical methods. RAC proposed to exempt from the restriction photographic coatings applied to films, papers or printing plates, implantable medical devices and substances or mixtures used in semiconductor and photolithography processes, considering the relatively low environmental impact and long substitution timeframes. RAC also proposed to exempt the use of substances as transported isolated intermediates in order to allow the manufacture of alternatives, as well as the placing on the market of second-hand articles.

(5)

On 4 December 2015, the Agency's Committee for Socio-Economic Analysis (‘SEAC’) adopted its opinion, indicating that the restriction proposed in the Annex XV dossier, as modified by RAC and SEAC, is the most appropriate Union-wide measure to address the identified risks in terms of its socioeconomic benefits and socioeconomic costs.

(6)

SEAC agreed with the exemptions proposed by RAC. In addition, SEAC suggested a three year deferral of the restriction, instead of the eighteen months proposed in the Annex XV dossier, to allow stakeholders to take the necessary compliance measures. Based on socioeconomic considerations, such as high costs, significant economic burden, lack of alternatives, relatively low emissions to the environment, critical uses with high societal benefits, SEAC suggested longer deferrals of the restriction for latex printing inks, textiles for the protection of workers, membranes intended for medical textiles, filtration in water treatment, production processes, and effluent treatment, certain plasma nano-coatings and non-implantable medical devices.

(7)

SEAC also suggested to exempt from the proposed restriction fire-fighting foams already placed on the market before the date of application of the restriction, and semiconductor manufacturing equipment.

(8)

The Agency's Forum for Exchange of Information on Enforcement, referred to in Article 76(1)(f) of Regulation (EC) No 1907/2006, was consulted during the restriction process and its opinion has been taken into account.

(9)

On 12 January 2016, the Agency submitted the opinions of the RAC and the SEAC (4) to the Commission.

(10)

Based on those opinions, the Commission concluded that an unacceptable risk to human health and the environment arises from the manufacture, use or placing on the market of PFOA, its salts and PFOA-related substances on their own, as a constituent of other substances, in mixtures and in articles. The Commission considers that those risks need to be addressed on a Union wide basis.

(11)

Perfluorooctane sulfonic acid (‘PFOS’) and its derivatives should be exempted from the proposed restriction, since those substances are already regulated by Regulation (EC) No 850/2004 of the European Parliament and of the Council (5). The unavoidable production of PFOA during the manufacture of fluorochemicals with a carbon chain equal to or shorter than six atoms should also be exempted from the proposed restriction.

(12)

As advised by SEAC, the application of the restriction should be deferred generally for a period of three years and for longer periods in relation to specified sectors in order to enable stakeholders to comply with the proposed restriction. While a standard analytical method is available for the determination of extractable PFOS in coated and impregnated solid articles, liquids and firefighting foams (CEN/TS 15968:2010), which most likely can be adjusted to also include PFOA and PFOA-related substances with a relevant detection limit, at present no such standard method is available for extraction and chemical analysis of those substances. The deferral period for the restriction should allow the further development of suitable analytical methods that can be applied to all matrices.

(13)

Regulation (EC) No 1907/2006 should therefore be amended accordingly.

(14)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

14.6.2017   

EN

Official Journal of the European Union

L 150/19