Exceptions
§ 2 in the REACH regulation names a set of materials, which
are excluded either totally or partly from the regulations of REACH.
The regulation applies not to:
- radioactive substances,
- materials, which are subject completely to customs monitoring
- not isolated intermediates
- the transport of dangerous materials.
- wastes are by definition no materials, prepartions or products in the sense of the REACH regulation.
The regulations for the registration, evaluation and authorisation as well as the obligations of the Downstream Users and the duties to supply information along the delivery chain do not apply to the following materials:
- human and animal pharmaceuticals
- food and feed, including their auxiliary and flavour materials.
To these materials already comparable joint regulations apply.
The regulations relative the duties to supply information along the delivery chain do not apply to
- cosmetics
- pharaceutical products
To these materials already comparable joint regulations apply.
From the regulations to the registration and evaluation as well as the obligations of the Downstream Users are excluded:
- materials according to appendix IV (e.g. water, determined sugar, natural oils) where sufficient information is available and it is believed that they will cause a minor risk according to their properties.
- materials mentioned in appendix V (e.g. minerals, coal, crude oils, natural gas, ores), since for these materials a registration and an evaluation are regarded inappropriate or unnecessary
- already registered materials, within REACH re-imported into the European Union or recycled in the European Union.
From the general registration and the general information requirements as well as the authorisation regulations are excluded:
- side-internal isolated as well as transported isolated intermediates.
From the registration as well as the regulations to the evaluation are excluded (up to further):
- polymers in the sense of the article 3, NR. 4. monomers and additives and as such products are subject to the registration requirements however
The following materials are considered as registered and are excluded therefore from the general registration requirements; these materials are also not subject to authorisation:
- active substances and formulation auxiliary materials, which are manufactured or imported exclusively for use in plant protection agents;
- active substances, which are manufactured or imported exclusively for use in biocide products and which were taken up to the old active substance program according to the biocide regulations.
For these materials the necessary material knowledge and use regulations are gained by special regulations.
The following materials are considered likewise as registered and are excluded therefore from the general registration requirements:
- new materials, which were announced in the context of the material guideline 67/548/EWG. For these materials supplement information is necessary, if they exceed certain quantity thresholds, which involves further duties to supply information.
Special arrangements exist for the registration (for the duration of five years), for the authorisation regulations as well as for the restriction regulations for
- product and process engineering research and development materials. To these materials a general notification obligation applies.
From the REACH authorisation regulations the following materials and uses are excluded:
- scientific research and development, - engine fuels, - mineral oil products as fuel, - cosmetics (partial), - food requirements articles (partial), - materials, which lie below certain concentrations (partly).
From the restiction regulations are excluded:
- scientific research and development,
- cosmetics (partial).