COMMISSION REGULATION (EU) No …/..

of XXX

amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

(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 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 1 , and in particular Articles 58 and 131 thereof,

Whereas:

(1)The substances 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear, and  dihexyl phthalate and the substance group 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0,3% of dihexyl phthalate meet the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council 2 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.

(2)The substance trixylyl phosphate 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 substances sodium perborate; perboric acid, sodium salt and sodium peroxometaborate 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.

(4)The substances 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] (covering any of the individual stereoisomers of [1] and [2] or any combination thereof) (‘karanal group’) are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII to Regulation (EC) No 1907/2006 and therefore meet the criteria for inclusion in Annex XIV to that Regulation set out in Article 57(e) of that Regulation.

(5)The substances 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328); 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327); 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) and 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) are persistent, bioaccumulative and toxic and/or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII to Regulation (EC) No 1907/2006 and therefore meet the criteria for inclusion in Annex XIV to that Regulation set out in Article 57(d) and/or (e) of that Regulation.

(6)All the above-mentioned 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 10 November 2016 3  and 5 February 2018 4 , in accordance with Article 58(3) and (4) of that Regulation. In addition, the Commission has received submissions from interested parties to calls for information on the possible economic, social, health and environmental impacts (costs and benefits) of the inclusion in Annex XIV to Regulation (EC) No 1907/2006 of the substances proposed by the Agency in its draft recommendations. 

(7)The substance diazene-1,2-dicarboxamide (C,C'-azodi(formamide)) (ADCA) meets the criteria for classification as a respiratory sensitiser (category 1) in accordance with section 3.4 of Annex I to Regulation (EC) No 1272/2008. This substance has been identified in accordance with Article 57(f) of Regulation (EC) No 1907/2006 due to its respiratory sensitising properties, 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 that Regulation. This substance was included in the candidate list in accordance with Article 59 and prioritised for inclusion in Annex XIV to that Regulation by the Agency's recommendation of 6 February 2014 5 , in accordance with Article 58(3) and (4) of that Regulation. In Commission Regulation (EU) 2017/999 6  it was decided to postpone the inclusion of this substance in Annex XIV to Regulation (EC) No 1907/2006 as the experience for handling authorisation applications covering broad ranges of uses was still limited at that time. In the light of the experience gained in processing applications for authorisation regarding substances with very diverse uses, the Commission considers it appropriate to now include this substance in Annex XIV to Regulation (EC) No 1907/2006.

(8)For each of the substances included in Annex XIV to Regulation (EC) No 1907/2006 by this Regulation a date from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted should be set as required by Article 58(1)(c)(i) of Regulation (EC) No 1907/2006, taking into account the Agency’s capacity to handle applications for authorisation. For each of those substances there are no reasons why the date referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006 should be set earlier than 18 months before the date referred to in Article 58(1)(c)(i) of that Regulation.

(9)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.

(10)As there is no information justifying the need for an exemption for product and process orientated research and development, it is not appropriate to consider any such exemption.

(11)As the available information on the uses of the proposed substances is limited, it is not appropriate to set review periods at this stage, pursuant to Article 58(1)(d) of Regulation (EC) No 1907/2006 . 

(12)The substances tetralead trioxide sulphate; pentalead tetraoxide sulphate; orange lead (lead tetroxide) and lead monoxide (lead oxide) meet the criteria for classification as toxic for reproduction (category 1A) 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 10 November 2016 in accordance with Article 58 (3) and (4) of that Regulation. The use of lead and its compounds is covered by Council Directive 98/24/EC 7 and to some extent by Directive 2010/75/EU of the European Parliament and of the Council and its implementing measures establishing Best Available Techniques (BAT) conclusions. Furthermore the current Union binding occupational limit value and binding biological limit value for lead compounds under Directive 98/24/EC will be reviewed. Therefore, and in view of possible adoption of more stringent measures at the workplace, it is appropriate to postpone a decision on the inclusion of those substances in Annex XIV to Regulation (EC) No 1907/2006. In addition, through implementation of Directive 2010/75/EU and its predecessors, emissions of lead and its compounds to the environment have decreased and continue to decrease as shown by the European Pollutant Release and Transfer Register (E-PRTR) reporting and further reductions are expected as new BAT conclusions are adopted and as permits are updated to reflect them.

(13)All uses of 1-methyl-2-pyrrolidone (NMP) are restricted in accordance with Annex XVII to Regulation (EC) No 1907/2006. NMP has similar intrinsic properties to those of N,N-dimethylacetamide (DMAC) and N,N-Dimethylformamide (DMF), and the three substances have similar industrial uses and may be considered as interchangeable, at least for some uses, even if in general they cannot be considered ‘drop-in’ alternatives. In view of the similarities of the three substances in order to ensure a consistent regulatory approach 8 , the decision on the inclusion of NMP in Annex XIV to Regulation (EC) No 1907/2006 should be postponed, as has been done for DMAC and DMF when the Commission considered the Agency's recommendations of 17 January 2013 9 and of 6 February 2014 10 , respectively. 

(14)In order to avoid the premature obsolescence of articles or complex products that are no longer produced after the sunset dates referred to in 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 as articles or as complex products for the repair of those articles or complex products, where those articles or complex products 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 or complex products. In order to facilitate application for authorisation for those uses, the existing transitional arrangements should be extended, allowing the adoption of implementing measures for simplified application for authorisations in such cases. In addition, the wording of the notes to the table of Annex XIV to Regulation (EC) No 1907/2006 should be revised in order to ensure consistency of the terminology as regards articles and complex products in the light of the judgement of the Court of Justice in Case C-106/14 11 .

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

(16)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,

HAS ADOPTED THIS REGULATION:

Article 1

Annex XIV to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels,

(1)    OJ L 396, 30.12.2006, p. 1.

(2)    Regulation (EC) No 1272/2008 of the European Parliament and the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (OJ L 353, 31.12.2008, p. 1).

(3) https://echa.europa.eu/documents/10162/13640/7th_axiv_recommendation_november2016_en.pdf/3e11377b-edd8-46d3-a29c-1978c41db3ad

(4)     https://echa.europa.eu/documents/10162/13640/8th_axiv_recommendation_february2018_en.pdf/10a99e7d-0fac-ff1d-7f17-910d6edb61b9  

(5)     https://echa.europa.eu/documents/10162/13640/5th_a_xiv_recommendation_06feb2014_en.pdf/17ab7722-0164-4fe8-80b6-8b4ac76e8f0f

(6)    Commission Regulation (EU) 2017/999 of 13 June 2017 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 150, 14.6.2017, p. 7).

(7)    Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).

(8)     https://echa.europa.eu/rmoa/-/dislist/details/0b0236e181ffe81a

(9)     https://echa.europa.eu/documents/10162/13640/4th_a_xiv_recommendation_17jan2013_en.pdf/cfa4a66b- 9d82-4e45-8cb7-920593db92c1

(10)     https://echa.europa.eu/documents/10162/13640/5th_a_xiv_recommendation_06feb2014_en.pdf/17ab7722-0164-4fe8-80b6-8b4ac76e8f0f

(11)    Judgment of the Court of Justice of 10 September 2015, Fédération des entreprises du commerce et de la distribution (FCD) and Fédération des magasins de bricolage et de l’aménagement de la maison (FMB), C106/14, ECLI:EU:C:2015:576.

ANNEX

The table in Annex XIV to Regulation (EC) No 1907/2006 is amended as follows:

(1)    The following entries are added:

(2)    The sign ‘*’     is inserted next to the date indicated in the ‘Latest application date’ column for the following substance entries: 32-43.

(3)    The sign ‘**’    is inserted next to the date indicated in the ‘Sunset date’ column for the following substance entries: 32-43.

(4)    The notes after the table are replaced by the following:

‘(*) 1 September 2021 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles and the latter cannot function as intended without that spare part and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.

(**) 1 March 2023 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles and the latter cannot function as intended without those spare parts and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products, where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.

(***) Does not meet the criteria for identification as a carcinogen if it contains < 0,005 % (w/w) benzo[a]pyrene (Einecs No 200-028-5).’