Some Background on the EU regulations
REACH is the abbreviation used for the EU regulation (REACH Chemicals Directive 1907/2006) concerning the "'Registration, Evaluation, Authorisation and Restriction of Chemicals'. As a regulation, it applies automatically to all 27 EU member states as well as Norway, Iceland and Liechtenstein (but not Switzerland). The REACH regulation is administered by the European Chemicals Agency (ECHA) based in Helsinki. The impact of REACH is as follows:
Every chemical made in or imported in the EU (plus Norway, Iceland and Liechtenstein) in a quantity over 1 tonne per annum (tpa) must be registered in some form. This does not just apply to pure chemicals but also formulated products and the monomers used to make polymers. Registration is subject to a fee, which varies, along with the content of the dossier, according to the tonnage band applied for. The fee and required and content of the registration dossier are greatest for the highest > 1000tpa tonnage band. There are reduced information requirements and a reduced registration fee for substances only used as intermediates provided it can be demonstrated that they are produced and used under strictly controlled conditions. Registration of a substance for Process and Product Oriented Research and Development (PPORD) is also possible, again with reduced data requirements and cost.
Registrants of substances (chemicals) must work together in ‘joint registrations’ – the so called ‘One substance, one registration’ principle, so new registrants would likely need to joint an existing registration unless their substance is completely novel. The only exception to this is that joint registrations can exist for both a full registration and an intermediate use only registration.
Only legal entities registered in the EU can register under REACH. Manufacturers outside Europe may appoint an Only Representative to register on their behalf to avoid all of their importers having to register individually. A trading company outside the EU cannot appoint an Only Representative. Registration is by individual manufacturing or importing legal entity.
There are exemptions from the need to register for substances when used in areas covered by existing legislation (eg. biocides, cosmetics), substances already regarded as registered and certain substances where it is considered that sufficient information is available that they can be considered to present minimal risk.
REACH initially required that at least 5% of dossiers to be subject to ‘dossier evaluation’, when a specific number of items in the target dossier will be subject to detailed evaluation. However, with the development of electronic screening tools for dossier checking, ECHA is expected to try to check nearly all dossiers to some degree for data completeness. As a result of dossier evaluation, registrants may be required to make good any shortcomings identified by ECHA, including completing new studies. In addition, a Community Rolling Action Plan (CoRAP) first created in 2012 and now updated annually permits member states to identify substances for ‘substance evaluation’ when all aspects of the dossiers, including the Chemical Safety Report and exposure scenarios if applicable from all registrants, are examined in fine detail.
A restriction system, very similar to the repealed directive on ‘Restrictions on Marketing and Use’, operates to restrict the use of certain chemicals in certain applications.
Substances of ‘Very High Concern’ (those classified as carcinogens, mutagens or toxic to reproduction category 1 (CMRs) under the Globally Harmonised System of Classification and Labelling along with substances identified as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB)), will normally be subject to authorisation, where only uses that can be demonstrated as safe and/or uses where the socio-economic benefits outweigh the adverse risks from use will be permitted. Other substances with properties of ‘similar concern’, such as endocrine modulators, can also be proposed as SVHC substances.
