Commission Implementing Decision (EU) 2016/1950
of 4 November 2016
on the non-approval of certain biocidal active substances pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products , and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1)
Commission Delegated Regulation (EU) No 1062/2014 , in its Annex II, part 2, establishes a list of active substance/product-type combinations, which were not supported on 4 August 2014 and for which, pursuant to Article 14(3) of that Regulation, any person could notify its interest to take over the role of participant for one or more of these substance/product-type combinations within 12 months from the date of entry into force of that Regulation.
(2)
For some substance/product-type combinations no interest has been expressed, or, when an interest was expressed, the notification was rejected pursuant to paragraph 4 or 5 of Article 17 of Delegated Regulation (EU) No 1062/2014.
(3)
In accordance with Article 20 of that Regulation, those substance/product-type combinations should not be approved for use in biocidal products.
(4)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
The active substances listed in the Annex to this Decision are not approved for the product-types indicated therein.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 4 November 2016.
For the Commission
The President
Jean-Claude Juncker
ANNEX
Active substance/product type combinations not approved:
- the substance/product-type combinations listed in the table below, including any nanomaterial forms,
- any nanomaterial forms of all substance/product-type combinations listed in the table in Annex II, part 1 of Delegated Regulation (EU) No 1062/2014, except those nanomaterial forms listed in that table, and
- any nanomaterial forms of all active substance/product-type combinations approved by 4 August 2014, except those explicitly approved.
Entry Number in Annex II to Delegated Regulation (EU) No 1062/2014 | Substance name | Rapporteur Member State | EC number | CAS number | Product-type(s)
1021 | 1,3-dichloro-5,5-dimethylhydantoin (redefined as per entry 152) | NL | 204-258-7 | 118-52-5 | 11
166 | Cetalkonium chloride (see entry 948) | IT | 204-526-3 | 122-18-9 | 1, 2, 3, 4, 8, 10, 11, 12
167 | Benzyldimethyl(octadecyl)ammonium chloride (see entry 948) | IT | 204-527-9 | 122-19-0 | 1, 2, 3, 4, 8, 10, 11, 12
213 | Benzododecinium chloride (see entry 948) | IT | 205-351-5 | 139-07-1 | 1, 2, 3, 4, 8, 10, 11, 12
214 | Miristalkonium chloride (see entry 948) | IT | 205-352-0 | 139-08-2 | 1, 2, 3, 4, 8, 10, 11, 12
331 | Didecyldimethylammonium bromide (see entry 949) | IT | 219-234-1 | 2390-68-3 | 1, 2, 3, 4, 8, 10, 11, 12
384 | Dimethyldioctylammonium chloride (see entry 949) | IT | 226-901-0 | 5538-94-3 | 1, 2, 3, 4, 8, 10, 11, 12
399 | Benzyldodecyldimethylammonium bromide (see entry 948) | IT | 230-698-4 | 7281-04-1 | 1, 2, 3, 4, 8, 10, 11, 12
418 | Silicon dioxide — amorphous | FR | 231-545-4 | 7631-86-9 | 18
449 | Copper sulphate | FR | 231-847-6 | 7758-98-7 | 2
554 | p-[(diiodomethyl)sulphonyl]toluene | UK | 243-468-3 | 20018-09-1 | 2
587 | Decyldimethyloctylammonium chloride (see entry 949) | IT | 251-035-5 | 32426-11-2 | 1, 2, 3, 4, 8, 10, 11, 12
601 | Benzyldimethyloleylammonium chloride (see entry 948) | IT | 253-363-4 | 37139-99-4 | 1, 2, 3, 4, 8, 10, 11, 12
615 | 3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (Permethrin) | IE | 258-067-9 | 52645-53-1 | 9
637 | Quaternary ammonium compounds, benzylcoco alkyldimethyl, chlorides (see entry 948) | IT | 263-080-8 | 61789-71-7 | 1, 2, 3, 4, 8, 10, 11, 12
638 | Quaternary ammonium compounds, dicocoalkyl dimethyl, chlorides (see entry 949) | IT | 263-087-6 | 61789-77-3 | 1, 2, 3, 4, 8, 10, 11, 12
639 | Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides (see entry 949) | IT | 263-090-2 | 61789-80-8 | 1, 2, 3, 4, 8, 10, 11, 12
647 | Quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, chlorides (see entry 948) | IT | 264-151-6 | 63449-41-2 | 1, 2, 3, 4, 8, 10, 11, 12
668 | Quaternary ammonium compounds, di-C6-12-alkyldimethyl, chlorides (see entry 949) | IT | 269-925-7 | 68391-06-0 | 1, 2, 3, 4, 8, 10, 11, 12
670 | Quaternary ammonium compounds, benzyl-C8-16-alkyldimethyl, chlorides (see entry 948) | IT | 270-324-7 | 68424-84-0 | 1, 2, 3, 4, 8, 10, 11, 12
689 | Quaternary ammonium compounds, benzyl-C10-16-alkyldimethyl, chlorides (see entry 948) | IT | 273-544-1 | 68989-00-4 | 1, 2, 3, 4, 8, 10, 11, 12
692 | Amines, C10-16-alkyldimethyl, N-oxides | PT | 274-687-2 | 70592-80-2 | 2
697 | Quaternary ammonium compounds, di-C8-18-alkyldimethyl, chlorides (see entry 949) | IT | 277-453-8 | 73398-64-8 | 1, 2, 3, 4, 8, 10, 11, 12
1000 | Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-) hexahydrate | PL | 279-013-0 | 14915-85-4 | 2
998 | Margosa extract other than from the kernels of Azadirachta indica extracted with water and further processed with organic solvents and other than from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide | DE | 283-644-7 | 84696-25-3 | 18
741 | Quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, bromides (see entry 948) | IT | 293-522-5 | 91080-29-4 | 1, 2, 3, 4, 8, 10, 11, 12
1020 | 1,3-dichloro-5-ethyl-5-methylimidazolidine-2,4-dione (redefined as per entry 777) | NL | 401-570-7 | 89415-87-2 | 11
778 | 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol (Tebuconazole) | DK | 403-640-2 | 107534-96-3 | 9
805 | Reaction product of dimethyl adipate, dimethyl glutarate, dimethyl succinate with hydrogen peroxide (Perestane) | HU | 432-790-1 | Not applicable | 2
923 | Alkyl-benzyl-dimethylammonium chloride/Benzalkonium chloride (see entry 948) | IT | Mixture | 8001-54-5 | 1, 2, 3, 4, 8, 10, 11, 12
949 | Quaternary ammonium compounds (dialkyldimethyl (alkyl from C6-C18, saturated and unsaturated, and tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or methylsulphates) (DDAC) | IT | Mixture of Einecs listed substances | Not applicable | 1, 2, 3, 4, 8, 10, 11, 12
950 | Quaternary ammonium compounds (alkyltrimethyl (alkyl from C8-C18, saturated and unsaturated, and tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or methylsulphates) (TMAC) | IT | Mixture of Einecs listed substances | Not applicable | 8
948 | Quaternary ammonium compounds (benzylalkyldimethyl (alkyl from C8-C22, saturated and unsaturated, tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or hydroxides) (BKC) | IT | Mixture of Einecs listed substances | Not applicable | 1, 2, 3, 4, 8, 10, 11, 12
849 | 3-phenoxybenzyl (1R)-cis,trans-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (d-Phenothrin) | IE | Not applicable | 188023-86-1 | 18
1001 | Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides (other than the substance covered by entry 671) | IT | Not applicable | Not applicable | 1, 2, 3, 4, 8, 10, 11, 12, 22
1002 | Quaternary ammonium compounds, benzyl-C12-18-alkyldimethyl, chlorides (other than the substance covered by entry 667) | IT | Not applicable | Not applicable | 1, 2, 3, 4, 10, 11, 12, 22
1003 | Quaternary ammonium compounds, C12-14-alkyl[(ethylphenyl)methyl]dimethyl, chlorides (other than the substance covered by entry 725) | IT | Not applicable | Not applicable | 1, 2, 3, 4, 10, 11, 12, 22
1005 | Quaternary ammonium compounds, benzyl-C12-14-alkyldimethyl, chlorides (other than the substance covered by entry 724) | IT | Not applicable | Not applicable | 1, 2, 3, 4, 10, 11, 12, 22
1006 | Silver-zinc-aluminium-boronphosphate glass/Glass oxide, silver- and zinc-containing | SE | Not applicable | 398477-47-9 | 2, 7, 9
1009 | Quaternary ammonium compounds, di-C8-10-alkyldimethyl, chlorides (other than the substance covered by entry 673) | IT | Not applicable | Not applicable | 1, 2, 3, 4, 5, 6, 10, 11, 12
1011 | Quaternary ammonium compounds, coco alkyltrimethyl, chlorides (other than the substance covered by entry 635) | IT | Not applicable | Not applicable | 8
1012 | Aluminium sodium silicate-silver zinc complex/Silver-Zinc-Zeolite | SE | Not applicable | 130328-20-0 | 2, 7, 9
598 | (±)-1-(.beta.-allyloxy-2,4-dichlorophenylethyl)imidazole (Technical grade imazalil) | DE | Plant protection product | 73790-28-0 | 3
OJ L 167, 27.6.2012, p. 1.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).