Address https://gelex.eu/eli/EU/regulation/2005/642@2005-04-27/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
3. ANNEX
4. ANNEX

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of risks of existing substances, and in particular Article 10(2) thereof,

Whereas:

(1) The rapporteurs designated by the Member States in accordance with Article 10(1) of Regulation (EEC) No 793/93 have evaluated the information submitted by the manufacturers and importers in respect of certain priority substances. After consultation of those manufacturers and importers, the rapporteurs have determined that it is necessary for the purposes of the risk evaluation to require those manufacturers and importers to submit further information and carry out further testing.

(2) The information needed to evaluate the substances in question is not available from former manufacturers or importers. The manufacturers and importers have checked that tests on animals cannot be replaced or limited by using other methods.

(3) It is therefore appropriate to request manufacturers and importers of priority substances to submit further information and carry out further testing of those substances. The protocols submitted by the rapporteurs to the Commission should be used for performing those tests.

(4) The provisions of this Regulation are in accordance with the opinion of the Committee established pursuant to Article 15 of Regulation (EEC) No 793/93,

HAS ADOPTED THIS REGULATION:

Article 1

The manufacturers and importers of the substances listed in the Annex, who have submitted information in accordance with the requirements of Articles 3, 4, 7 and 9 of Regulation (EEC) No 793/93, shall provide the information and perform the tests indicated in the Annex and shall deliver the results to the relevant rapporteurs. The tests shall be performed according to the protocols specified by the rapporteurs. The results shall be delivered within the time limits laid down in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following 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, 27 April 2005. For the Commission Stavros Dimas Member of the Commission

ANNEX

ANNEX

No Einecs No CAS No Substance name Rapporteur Testing/information requirements Time limit from the date of entry into force of this Regulation 1 201-245-8 80-05-7 4,4′-Isopropylidenediphenol UK Long-term fish endocrine effects study with investigation of effects on sperm development 18 months Long-term toxicity study with an appropriate freshwater snail species 18 months 2 generation study with 4,4′-isopropylidenediphenol in mice according to OECD 416 (with some specific modifications) 39 months 2 203-545-4 108-05-4 Vinyl acetate D Further data on pattern of polymerisation facilities and information on exhaust air purification techniques for representative facilities 6 months 3 202-627-7 98-01-1 2-Furaldehyde NL Long-term toxicity test with fish 6 months Long-term toxicity test with daphnia 6 months 4 201-622-7 85-68-7 Benzyl butyl phthalate N Data about releases into the Wupper from all sources 12 months Plant fumigation test 12 months Long-term fish study on reproductive and endocrine effects 12 months Monitoring study on local air concentrations near flooring production sites and sealant formulation plants 12 months 5 201-329-4 81-15-2 5-Tert-butyl-2,4,6-trinitro-m-xylene NL Biodegradation simulation test for determination of half-life in marine environment 18 months 6 200-663-8 67-66-3 Chloroform F Environmental exposure information for production and uses 6 months Two long-term toxicity tests on sediment organisms 6 months Toxicity tests on micro-organisms: 6 months 7 202-974-4 101-77-9 4,4′-Methylenedianiline D Long-term toxicity test on sediment organisms (Chironomus spec.) 6 months Long-term toxicity test on sediment organisms (Hyalella azteca) 6 months 8 231-152-8 215-146-2 7440-43-9 1306-19-0 Cadmium Cadmium oxide B Ecotoxicity tests under very low water hardness conditions 12 months Validation of applicability of SEM/AVS concept (bioavailability in sediment compartment) 12 months 9 231-668-3 7681-52-9 Sodium hypochlorite IT Whole effluent assessment 9 months 10 247-148-4 25637-99-4 Hexabromocyclododecane S Biodegradation simulation test providing valid half-lives as well as identification of metabolites 8 months 11 201-236-9 79-94-7 Tetrabromobisphenol-A UK Clarification of use pattern 9 months Long term toxicity test with Chironomus riparius in sediment 9 months Long term toxicity test with Chironomus riparius in water 9 months Toxicity study with molluscs 9 months Investigation of degradation to bisphenol-A in sediment 9 months 12 287-476-5 85535-84-8 Alkanes, C10-13, chloro (SCCPs) UK Environmental exposure information on emissions 3 months Biodegradation simulation test to determine half-life in the marine environment 18 months

tests on activated sludge for production sites

nitrification inhibition test

test on the inhibition of methanogenic bacteria

Versions

1. 2005-04-27

Cited by

• Commission Decision of 7 June 2007 concerning national provisions on the use of short-chain chlorinated paraffins notified by the Kingdom of the Netherlands under Article 95(4) of the EC Treaty (notified under document number C(2007) 2361) (Only the Dutch text is authentic) (Text with EEA relevance) (2007/395/EC) Decision · Grade B

  Following the outcome of the earlier risk assessment and its reviews by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE), the Commission adopted pursuant to Article 10 of Regulation (EEC) No 793/93, Commission Regulation (EC) No 642/2005 imposing testing and information requirements on the importers or manufacturers of certain priority substances. This regulation requires the industry to provide additional information on environmental exposure and biodegradation simulation to determine half-life in the marine environment, which were deemed necessary in order to all

• Commission Decision of 7 June 2007 concerning national provisions on the use of short-chain chlorinated paraffins notified by the Kingdom of the Netherlands under Article 95(4) of the EC Treaty (notified under document number C(2007) 2361) (Only the Dutch text is authentic) (Text with EEA relevance) (2007/395/EC) Decision · Grade B

  The relevant industry association (Euro Chlor) submitted information in 2004 indicating that there had been a further decrease in the use of SCCPs in all applications since 2001. The EU consumption in textiles and rubber had decreased in 2003 to a third of the level in 2001, with further decreases occurring (particularly in use in textiles, paints and sealants and adhesives) in 2004. The consumption in paints and sealants/adhesives also decreased by 50 % over the same time period. Some use in metal working fluids was still occurring in 2003, but this use stopped in 2004 following the entry int

• Commission Decision of 7 June 2007 concerning national provisions on the use of short-chain chlorinated paraffins notified by the Kingdom of the Netherlands under Article 95(4) of the EC Treaty (notified under document number C(2007) 2361) (Only the Dutch text is authentic) (Text with EEA relevance) (2007/395/EC) Decision · Grade B

  On the other hand, there have been further developments at European level that have increased the available knowledge base. The results of the biodegradation testing required under Regulation (EC) No 642/2005 seem to suggest that the mineralisation rate is slow so that the persistence criterion of PBT substances will be met.