The registration dossier consists of:

• a technical dossier

and in the case for tonnages of >10 tons per year

• a chemical safety report

The registration deadlines depend on tonnage produced or imported and on the hazard of
the substance.

For substances newly introduced in the EU market the registration starts June 1, 2008.

Authorization

Substances of very high concern must be authorized under REACH and their use may be
subject to restrictions. This applies to:

CMR substances

 Substances which are considered carcinogenic

 Substances which are considered mutagenic
 Substances which are considered toxic to reproduction

PBT substances

 Substances which are persistent, bioaccumulative and toxic according to Annex

XIII

vPvB substances

 Substances which are very persistent and very bioaccumulative according to

Annex XIII

Substances with particular properties

 which according to scientific knowledge have a likely latent effect upon humans
and the environment, giving rise to the same concerns as the above-mentioned
substance groups, e.g. endocrine disruptors

Affected substances

Registration of chemicals

REACH distinguishes between Phase-in und Non-Phase-in substances:

• Phase-in substances can be pre-registered and afterwards must be registered based

on tonnage according to the registration deadline.
 • Non-Phase-in substances must be registered immediately with the exception that
chemicals already notified under the former chemicals system will be considered
registered under REACH.

Exemptions

Substances which are considered as registered

 Active substances and co-formulants in plant protection compounds and biocides

 Substances registered according to Council directive 67/548/EEC (new substance
registration)

A number of substances currently on the market are not covered by REACH and are
exempted from registration:

 Radioactive substances
 Substances liable to customs duty
 Non-isolated intermediates
 Substances used in medication or as food additives
 Substances according to REACH Annex IV (e.g. water, certain sugars, natural
oils, fatty acids)
 Substances according to REACH Annex V (certain reactive products, minerals,
carbon, crude oil, natural gas)
 Polymers (monomers and possibly additives are however subject to registration)

Specially regulated are:

 Product and procedure oriented Research and Development

 Isolated intermediates

Data requirements

The data requirements depend on production and import quantities for all applications.

Data requirements for category 1-10 t/a

For substances already on the market (phase-in-substances) in this tonnage category,

physical and chemical data only are required at this time. In view of the already existing
data, it must then be decided whether and which further data have to be generated. For
new substances (non-phase-in-substances), a complete data set according to Annex VII,
with information addressing the following points, must be submitted:

Physical-chemical data

Density
Melting and boiling point
Water solubility
Vapour pressure (log Pow)
Flash point
Flammability/Self ignition temperature
Explosivity
Impact on surface tension
Oxidising properties
Granulometry (regarding solids)

Toxicological data

Acute oral toxicity

Skin irritation (in-vitro)
Eye irritation (in-vitro)
Skin sensitization
Mutagenicity (Ames-Test)

Ecotoxicological data

Acute toxicity to daphnids

Toxicity to algae
Ready biodegradability

Data requirements for category 10-100 t/a

For substances in this tonnage category, in addition to the requirements in Annex VII,
further toxicological and ecotoxicological tests according to Annex VIII must be carried
out:

Toxicological data

Skin sensitisation (in vivo)

Eye sensitisation (in vivo)
In vitro cytogenetic testing in mammal cells
In vitro gene mutation test in mammal cells
Acute toxicity (dermal and/or inhalation
Short-term toxicity study (28-day)
Reproductive and developmental toxicity
(Screening test)
Evaluation of the toxicokinetic behaviour

Ecotoxicological data

Short-term toxicity to fish

Activated sludge inhibition test
Abiotic degradability (Hydrolysis)
Adsorption- / Desorption-Screening

Under certain circumstances, the performance of certain tests may be waived.

Data requirements for category 100-1000 t/a

Annex IX applies to this tonnage category. In addition to the requirements of Annexes

VII and VIII, the registrant must submit a proposal regarding how and according to
which timeline he intends to fulfil the requirements of Annex IX.

Physical-chemical data

Stability in organic solvents and identity of relevant degradation products

Dissociation constant
Viscosity

Ecotoxicological data

Daphnia reproduction test (21-day)

Long-term toxicity for fish
Simulation of biotic degradation in surface water
Simulation of biotic degradation in soil
Simulation of deposits in the sediment
Identification of degradation products
Bioaccumulation in fish
Further studies on adsorption/desorption
Short-term testing for terrestrial invertebrates
Effects on soil microorganisms
Short-term toxicity to plants

Toxicological data

Sub-chronic toxicity study (90-day)

Reproduction toxicity
Prenatal development toxicity
2 generation reproduction toxicity test

Under certain circumstances, the performance of certain tests may be waived.

Data requirements for category >1000 t/a

Annex X applies to this tonnage category. In addition to the carrying out of the specified
tests in Annexes VII and VIII, the registrant must submit a proposal regarding how and
according to which timeline the registrant intends to fulfil the requirements of Annexes
IX and X.

Toxicological data

Reproduction toxicity
Development toxicity
Two generation reproduction toxicity test
Carcinogenicity test

Ecotoxicological data
Further testing of biotic degradation
Further information about fate and behaviour of the substance and/or its degradation
products in the environment
Long-term toxicity for terrestrial invertebrates
Long-term toxicity for sediment organisms
Long-term toxicity for birds

Technical dossier

For all substances to be registered a technical dossier has to be submitted consisting of

the following information:

 Identity of the responsible registrants

 Identity of the substance
 Information about the manufacturing and all uses of the substance
 Classification and labelling of the substance
 Guidelines for the safe use of the substance
 Study summaries of tests carried out
 Robust study summaries of tests carried out
 Information regarding which of the above mentioned points has been vetted by an
evaluator, having suitable experience and selected by either the manufacturer or
importer.
 Test recommendations, in the case tests are required according to
Annexes IX and/or X

Chemical safety report

For substances in the tonnage category >10 tons per year a chemical safety report has to
be submitted in addition to the technical dossier. The chemical safety report contains the
following information:

Part A

 Overview of risk management measures

 Explanations about the implementation of risk management measures
 Explanations about communication of risk management measures

Part B

 Identity and physical and chemical properties of the substance

 Manufacturing and uses
 Classification and labelling
 Movement and fate in the environment
 Human health risk assessment
 Human health risk assessment based on physical and chemical properties
 Environmental risk assessment
 PBT- und vPvB assessment
 Exposure assessment
 Risk characterisation
Safety data sheet

In line with the old legislation a safety data sheet for hazardous (and under certain
circumstances also for non-hazardous) substances and preparations has to be provided
under REACH. In addition a safety data sheet has to be provided for substances fulfilling
the PBT and vPvB criteria and for certain other substances. The safety data sheet also
must comprise information from the chemical safety report (exposure scenarios).