Commission Regulation (EC) No 2161/1999 of 12 October 1999 imposing further testing requirements on the importers or manufacturers of a certain priority substance as foreseen under Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances
Date: 1999-10-12
Institutions: European Commission
Subjects: dangerous substance, health control, health risk, producer's liability, product safety, testing

13. 10. 1999

EN

Official Journal of the European Communities

L 265/11

COMMISSION REGULATION (EC) No 2161/1999

of 12 October 1999

imposing further testing requirements on the importers or manufacturers of a certain priority
substance as foreseen under Council Regulation (EEC) No 793/93 on the evaluation and control of
the risks of existing substances

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 10(2) thereof,

(1) Whereas Article 10 of Regulation (EEC) No 793/93 fore-
sees that the Member State ‘Rapporteur’
for a given
substance shall be responsible for evaluating the infor-
mation submitted by the manufacturer(s) or importer(s)
and for identifying, after consultation of the producers
or importers concerned whether for the purposes of the
risk evaluation it is necessary to require the above manu-
facturers or importers to submit further information or
to carry out further testing;

(2) Whereas the Commission has been informed by one
Member State Rapporteur of the need to impose on the
importers or manufacturers of
certain priority
substance undergoing risk evaluation activities a request
for further testing within certain time limits;

a

(3) Whereas Article 12 of Regulation (EEC) No 793/93 fore-
sees that
in the case of a substance produced or
imported as such or in a preparation by several manu-
facturers/importers,
be
performed by one manufacturer/importer acting on

testing may

further

the

behalf of the other manufacturers/importers concerned
who shall make reference to the tests carried out and
shall make a fair and equitable contribution to the cost;

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

HAS ADOPTED THIS REGULATION:

Article 1

1.
The manufacturer(s) and importer(s), referred to in Article
10(1) of Regulation (EEC) No 793/93, of the substance listed in
the Annex to the present Regulation, shall perform the test
there indicated and shall deliver the relevant results to the
Member State Rapporteur.

2.
These results shall be delivered within the time limits also
indicated in the Annex (calculated from the date of entry into
force of this Regulation).

Article 2

into force on the third day
This Regulation shall enter
following its publication in the Official Journal of the European
Communities.

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

Done at Brussels, 12 October 1999.

For the Commission

Margot WALLSTRÖM

Member of the Commission

(1) OJ L 84, 5.4.1993, p. 1.

L 265/12

EN

Official Journal of the European Communities

13. 10. 1999

ANNEX

Einecs No

CAS No

Substance name

Rapporteur

Testing requirements

Months

1

263-125-1

61790-33-8

Amines, tallow alkyl (1)

D

OECD TG 421 (2)

6

(1) Substance listed in the Annex to Commission Regulation (EC) No 2268/95 (OJ L 231, 28.9.1995, p. 18)
(2) OECD's Guideline for the testing of chemicals — Section 4 health effects TG No 421: ‘Reproduction/developmental toxicity screening test’

(Original guideline adopted 27 July 1995)