Commission Regulation (EC) No 506/2007 of 8 May 2007 imposing testing and information requirements on the importers or manufacturers of certain priority substances in accordance with Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances (Text with EEA relevance )
Date: 2007-05-08
Institutions: European Commission
Subjects: chemical product, dangerous substance, exchange of information, health control, health risk, testing

L 119/24

EN

Official Journal of the European Union

9.5.2007

COMMISSION REGULATION (EC) No 506/2007

of 8 May 2007

imposing testing and information requirements on the importers or manufacturers of certain
priority substances in accordance with Council Regulation (EEC) No 793/93 on the evaluation
and control of the risks of existing substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(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,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Regulation (EEC) No 793/93 of
23 March 1993 on the evaluation and control of risks of
existing substances (1), and in particular Article 10(2) thereof,

Whereas:

(1)

(2)

(3)

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
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.

and importers,

the

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.

It is therefore appropriate to request manufacturers and
importers of priority substances to submit further infor-
mation and carry out further testing of those substances.
to the
The protocols
Commission should be used for performing those tests.

submitted by the rapporteurs

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
specified by the rapporteurs.

shall be performed according to the protocols

The results shall be delivered within the time limits laid down in
the Annex.

Article 2

This Regulation shall enter into force on the 20th 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, 8 May 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 Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

9.5.2007

EN

Official Journal of the European Union

L 119/25

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.

237-158-7

13674-84-5

Tris(2-chloro-1-methyl-
ethyl) phosphate (TCPP)

IE/UK

— 2-generation study — fertility effects (OECD

24 months

416-B35)

2.

237-159-2

13674-87-8

3.

253-760-2

38051-10-4

Tris[2-chloro-1-(chloro-
methyl)ethyl] phosphate
(TDCP)

2,2-Bis(chloromethyl)
trimethylene bis(bis(2-
chloroethyl)phosphate
(V6)

— In vivo Comet assay in rat liver

12 months

— In vitro percutaneous absorption of radiola-
belled TCPP through human skin (OECD
428)

12 months

IE/UK

— Sorption/desorption study (modified OECD

6 months

106 test)

IE/UK

— 2-generation study — fertility effects (OECD

24 months

416-B35)

— In vitro percutaneous absorption of radiola-
belled V6 through human skin (OECD 428)

12 months

4.

202-679-0

98-54-4

4-Tert-butylphenol

NO

— Endocrine effects

study with fish (draft

18 months

OECD ext. ELS test)

5.

202-411-2

95-33-0

N-cyclohexylben-
zothiazole-2-sulphe-
namide

DE

— Measured data from road border soils and
surface waters receiving runoff from roads.
The degradation products to be measured
benzothia-
are 2-mercaptobenzothiazole,
zole, 2-benzothiazolone, 2-methylthioben-
zothiazole and 2-methylbenzothiazole

— Measured data on landfill

leachate. The
degradation products to be measured are
2-mercaptobenzothiazole, benzothiazole, 2-
benzothiazolone, 2-methylthiobenzothiazole
and 2-methylbenzothiazole

— Use and exposure information on tyre
recycling,
shredding
especially on tyre
facilities, on sport grounds using recycled
tyre material and on other similar open
uses of recycled tyres

4 years

4 years

4 years

6.

233-118-8

10039-54-0

Bis(hydroxylammonium)
sulphate

DE

— Daphnia magna reproduction test

(OECD

3 months

211)

— Exposure information from production and

3 months

processing

— Literature data on/or an Activated sludge
respiration inhibition test (OECD 209)

3 months

L 119/26

EN

Official Journal of the European Union

9.5.2007

No

Einecs No

CAS No

Substance name

Rapporteur

Testing/Information requirements

Time limit from the date
of entry into force of this
Regulation

7.

201-245-8

80-05-7

4,4′-isopropylidenedi-
phenol

UK

— Terrestrial plants growth test (OECD 208)

6 months

— Enchytraeid reproduction test (OECD 220)

6 months

— Reproduction test with a suitable springtail

6 months

species

8.

266-028-2

65996-93-2

Pitch,
temp.

coal

tar, high

NL

— STP sludge inhibition test (OECD 209 —

3 months

C11)