Page 13 - CITDBooklet

Guide on the application of REACH Regulation

■ If from the CSA the registrant concludes his substance is to be classified as dangerous
he must perform:

(a) an exposure assessment including the generation of exposure scenario(s) or
the identification of relevant use and exposure categories if appropriate) and
exposure estimation;

(b) a risk characterization

■ Safety data sheets must be prepared for hazardous substances

■ Each company has to pay a registration fee for the registration of each substance.

■ Small and Medium-sized Enterprises can benefit from reduced fees under the REACH
Regulation. The reductions depend on the company size as defined by the Commission
Recommendation 2003/361/EC.

2.1.2 Vertebrate animal Testing:

■ Among the fundamental objectives of the European Commission is 3R:

■ to replace and thus avoid or minimize,

■ reduce or

■ refine animal testing.

■ Existing ‘acceptable’ animal tests must not be repeated by the participants of a SIEF
(for a specific substance)

■ Alternative methods like (Q)SARs have to be used instead of animal testing whenever
applicable

■ Information related to testing will be published on the Agency website

■ Third party is invited to comment, make proposals, make available tests not yet known
to registrants and agency

Testing proposals have to be approved by the agency within certain timeframe (2/3/4 years
after registration deadlines 2010/13/18).

2.2 REACH Registration deadlines:

REACH registration deadlines are tonnage/annum/legal entity (t/a) based:
■ 1st Deadline: 30th November 2010 for

- substances > 1000 t/a or

- CMR’s (>1 t/a) or

- toxic to Environment when >100 t/a

■ 2nd Deadline: 1st June 2013 for

- substances >100t/a but <1000 t/a

■ 3rd Deadline: 1st June 2018 for

- substances > 1 t/a but < 100 t/a

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