Commission Recommendation

of 6 December 2007

on risk reduction measures for the substances: Piperazine; Cyclohexane; Methylenediphenyl diisocyanate; But-2yne-1,4-diol; Methyloxirane; Aniline; 2-Ethylhexylacrylate; 1,4-Dichlorobenzene; 3,5-dinitro-2,6-dimethyl-4-tert-butylacetophenone; Di-(2-ethylhexyl)phthalate; Phenol; 5-tert-butyl-2,4,6-trinitro-m-xylene

(notified under document number C(2007) 5901)

(Text with EEA relevance)

(2008/98/EC)

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 the risks of existing substances [1] and in particular Article 11(2) thereof,

Whereas:

(1) In the framework of Regulation (EEC) No 793/93 the following substances have been identified as priority substances for evaluation in accordance with Commission Regulations (EC) No 1179/94 [2], (EC) No 2268/95 [3] and (EC) No 143/97 [4] respectively concerning the first, second and third list of priority substances as foreseen under Regulation (EEC) No 793/93:

- Piperazine,

- Cyclohexane,

- Methylenediphenyl diisocyanate,

- But-2-yne-1,4-diol,

- Methyloxirane,

- Aniline,

- 2-Ethylhexylacrylate,

- 1,4-Dichlorobenzene,

- 3,5-dinitro-2,6-dimethyl-4-tert-butylacetophenone,

- Di-(2-ethylhexyl)phthalate (DEHP),

- Phenol,

- 5-tert-butyl-2,4,6-trinitro-m-xylene.

(2) The rapporteur Member States designated pursuant to those Regulations have completed the risk evaluation activities with regard to man and the environment for those substances in accordance with Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances [5] and have suggested a strategy for limiting the risks in accordance with Regulation (EEC) No 793/93.

(3) The Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) or the Scientific Committee on Health and Environmental Risks (SCHER) have been consulted and have issued opinions with respect to the risk evaluations carried out by the rapporteurs. The opinions have been published on the website of the Scientific Committees.

(4) The results of the risk evaluation and further results of the strategies for limiting the risks are set out in the corresponding Commission Communication of 7 February 2008 [6] on the risk evaluation and the risk reduction strategies for the substances: Piperazine; Cyclohexane; Methylenediphenyl diisocyanate; But-2yne-1,4-diol; Methyloxirane; Aniline; 2-Ethylhexylacrylate; 1,4-Dichlorobenzene; 3,5-dinitro-2,6-dimethyl-4-tert-butylacetophenone; Di-(2-ethylhexyl)phthalate; Phenol; 5-tert-butyl-2,4,6-trinitro-m-xylene.

(5) It is appropriate, on the basis of that evaluation, to recommend certain risk reduction measures for certain substances.

(6) The risk reduction measures recommended for workers should be considered within the framework of the legislation for workers protection, which is considered to provide an adequate framework to limit the risks of the relevant substances to the extent needed.

(7) The risk reduction measures provided for in this recommendation are in accordance with the opinion of the Committee set up pursuant to Article 15(1) of Regulation (EEC) No 793/93,

HEREBY RECOMMENDS:

SECTION 1

PIPERAZINE

(CAS No 110-85-0; Einecs No 203-808-3)

Risk reduction measures for the environment (1, 2, 3)

1. The competent authorities in the Member States concerned lay down conditions, emission limit values or equivalent parameters or technical measures regarding piperazine in the permits issued under Council Directive 96/61/EC [7] (Integrated Pollution Prevention and Control) in order to operate according to the best available techniques taking into account the technical characteristic of the installations concerned, their geographical location and the local environmental conditions.

2. Member States should carefully monitor the implementation of BAT regarding piperazine and report any important developments to the Commission in the framework of the exchange of information on BAT. To facilitate permitting and monitoring under Council Directive 96/61/EC (Integrated Pollution Prevention and Control) piperazine should be included in the ongoing work to develop guidance on "Best Available Techniques" (BAT).

3. Local emissions to the environment shall, where necessary, be controlled by national rules to ensure that no risk for the environment is expected.

SECTION 2

METHYLENEDIPHENYL DIISOCYANATE

(CAS No 26447-40-5; Einecs No 247-714-0)

Risk reduction measures for workers (4)

4. Employers using MDI for uses identified as a concern in the risk assessment should take note of any sector specific guidance developed at national level based on the practical non-binding guidance, to be published by and available from the Commission as foreseen under Article 12(2) of Council Directive 98/24/EC [8] (Chemical Agents Directive).

SECTION 3

BUT-2-YNE-1,4-DIOL

(CAS No 110-65-6; Einecs No 203-788-6)

Risk reduction measures for workers

5. Employers using But-2-yne-1,4-diol for uses identified as a concern in the risk assessment and especially the use of flakes, should take note of any sector specific guidance developed at national level based on the practical non-binding guidance, to be published by and available from the Commission as foreseen under Article 12(2) of Directive 98/24/EC (Chemical Agents Directive).

SECTION 4

ANILINE

(CAS No 62-53-3; Einecs No 200-539-3)

Risk reduction measures for workers (6), Consumers (7) and the environment (8, 9, 10, 11)

6. That employers using Aniline for use in to develop activities with foreseeable exposure (e.g. servicing or maintenance work on closed systems) should take note of any sector specific guidance developed at national level based on the practical non-binding guidance, to be published by and available from the Commission as foreseen under Article 12(2) of Directive 98/24/EC (Chemical Agents Directive).

7. Member States should carry out an active and effective market surveillance of the situation in their territories concerning the presence of Aniline containing consumer products and to notify the Commission through the Rapid Alert System of Directive 2001/95/EC [9] (General Product Safety). If proved necessary these products should be removed from the market as being unsafe under the general safety obligation provisions of the Directive.

8. For the river basins where emissions of Aniline may cause a risk, the relevant Member State(s) establish EQSs and the national pollution reduction measures to achieve those EQS in 2015 shall be included in the river basin management plans in line with the provisions of Council and Parliament Directive 2000/60/EC [10] (Water Framework Directive).

9. Competent authorities in the Member States concerned lay down conditions, emission limit values or equivalent parameters or technical measures regarding Aniline in the permits issued under Council Directive 96/61/EC (Integrated Pollution Prevention and Control) in order to operate according to the best available techniques taking into account the technical characteristic of the installations concerned, their geographical location and the local environmental conditions.

10. Member States should carefully monitor the implementation of BAT regarding Aniline and report any important developments to the Commission in the framework of the exchange of information on BAT. To facilitate permitting and monitoring under Council Directive 96/61/EC (Integrated Pollution Prevention and Control) Aniline should be included in the ongoing work to develop guidance on "Best Available Techniques" (BAT).

11. Local emissions to the aquatic environment and via air emissions of Aniline should, where necessary, be controlled by national rules to ensure that no risk for the environment is expected. The measures identified to protect the environment will also reduce exposure of humans via the environment.

SECTION 5

DI-(2-ETHYLHEXYL)PHTHALATE (DEHP)

(CAS No 117-81-7; Einecs No 204-211-0)

Risk reduction measures for the environment

12. For the river basins where emissions of DEHP may cause a risk, the relevant Member State(s) establish EQSs and the national pollution reduction measures to achieve those EQS in 2015 shall be included in the river basin management plans in line with the provisions of Council and Parliament Directive 2000/60/EC (Water Framework Directive).

SECTION 6

PHENOL

(CAS No 108-95-2; Einecs No 203-632-7)

Risk reduction measures for Consumers and the environment

13. Member States should carry out an active and effective market surveillance of the situation in their territories concerning the presence of consumer products containing phenol and, if necessary, should notify the Commission through the Rapid Alert System of Directive 2001/95/EC (General Products Safety Directive). If proven necessary, these products should be removed from the market as being unsafe under the general safety obligation provisions of the Directive.

14. Competent authorities in the Member States concerned should lay down, in the permits issued under Directive 96/61/EC, emission limit values or equivalent parameters or technical measures regarding phenol in order to operate by 31 October 2007 according to the BAT taking into account the technical characteristic of the installations concerned, their geographical location and the local environmental conditions. Competent authorities in the Member States concerned should pay special regard to potential risks from phenol production and/or processing sites, in respect of industrial wastewater treatment plants situated at such sites, and in respect of humans exposed via the environment (plant shoots contaminated by air emissions from such sites).

15. Member States should carefully monitor the implementation of BAT regarding phenol and report any important developments to the Commission in the framework of the exchange of information on BAT. To facilitate permitting and monitoring under Council Directive 96/61/EC (Integrated Pollution Prevention and Control) phenol should be included in the ongoing work to develop guidance on "Best Available Techniques" (BAT).

16. Local emissions to the environment and to industrial wastewater treatment plants should, where necessary, be controlled by national rules to ensure that no risk for the microorganisms in the industrial wastewater treatment plants and to humans exposed via the environment is expected.

SECTION 7

ADDRESSEES

17. This Recommendation is addressed to all sectors importing, producing, transporting, storing, formulating into a preparation or other processing, using, disposing or recovering the substances and to the Member States.

Done at Brussels, 6 December 2007.

For the Commission

Stavros Dimas

Member of the Commission

[1] OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parlament and of the Council (OJ L 284, 31.10.2003, p. 1).

[2] OJ L 131, 26.5.1994, p. 3.

[3] OJ L 231, 28.9.1995, p. 18.

[4] OJ L 25, 28.1.1997, p. 13.

[5] OJ L 161, 29.6.1994, p. 3.

[6] OJ C 34, 7.2.2008, p. 1.

[7] OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 1).

[8] OJ L 131, 5.5.1998, p. 11. Directive as amended by Directive 2007/30/EC of the European Parliament and of the Council (OJ L 165, 27.6.2007, p. 21).

[9] OJ L 11, 15.1.2002, p. 4.

[10] OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).

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