REACH and (pre-)registration in a nutshell - CHEMICALS
Everything you always wanted to know about preregistration - but were afraid to ask...
Compounds, mixtures and products
REACH, the new european regulation on chemical substances, has a very wide scope. It applies to all chemical substances which are manufactured, imported, placed on the market or used within the European Community, either on their own, in a preparation or in an article. So it affects not just the chemicals used in industrial processes, but also all chemicals occurring in our daily lives, for instance those in paint, detergents, and in products like clothing, furniture and electrical appliances.
There is a difference between pure compounds, chemicals in preparations (mixtures) and chemicals in articles (products). Definitions:
- - a substance is a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
- - a preparation is a mixture or solution composed of two or more substances that do not react;
- - an article (product) is an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.
(Articles that contain substances intended to be released get a special status.)
See Substances Identification (section 2.2) for a more comprehensive overview.
Which substances need to be (pre-)registered?
All existing (known) compounds need to be preregistered.
These are the substances in the so-called EINECS: European INventory of Existing commercial Chemical Substances.
If you don't know exactly if your substances are in the EINECS, just contact us.
Examples of compounds to be preregistered:
- - organic solvents (acetone, methanol, ethyl acetate)
- - monomers (basic ingredients for polymers, e.g. ethene, vinyl)
- - metals (copper, chromium, cadmium, mercury)
- - salts (copper sulphate, aluminum chloride, sodium acetate)
- - acids (sulphuric acid, acetic acid, hydrocyanic acid)
- - ammonia (gas)
All substances that are manufactured in or imported into the EU in quantities of 1 tonne or more per year should be (pre)registered.
The so called Substances of Very High Concern (SVHC) may be subject to authorization even if used, produced or important in (much) lower quantities.
The main categories of SVHCs are CMR, PBT and vPvB compounds:
- - C Carcinogenic - category 1 or 2 (Directive 67/548/EEC)
- - M Mutagenic - category 1 or 2 (Directive 67/548/EEC)
- - R toxic for Reproduction - category 1 or 2 (Directive 67/548/EEC)
- - PBT Persistent, Bioaccumulative and Toxic - see Annex XIII
- - vPvB very Persistent and very Bioaccumulative - see Annex XIII
- - substances of equivalent level of concern (like endocrine disruptors)
Ultimately, SVHCs will be published in Annex XIV of REACH.
Currently (July 2008) there are 16 SVHCs on the candidate list.
Exemptions
Compounds that are exempted from registration are:
- - substances occuring in nature (ores, crude oil), if untreated
- - substances that already fall under other regulations:
- - medicinal products for human or veterinary use
- - food or feeding stuff (including additives), flavouring or in animal nutrition
- - herbicides, biocides
- - radioactive substances
- - polymers (monomers need to be registered)
- - non-isolated intermediates
- - substances in temporary storage which do not undergo any treatment
- - transport of dangerous substances and preparations by rail, road, inland waterway, sea or air
- - waste (as defined in Directive 2006/12/EC)
- - certain substances where necessary in the interests of defence
This does not mean that, for instance, food manufacturerers have nothing to do with REACH. It is still possible that certain compounds used during the manufacturing process fall under REACH anyway.
A more complete overview of the substances exempted from registration can be found in Annex 4 and Annex 5:
Annex IV has a list of specific (natural) compunds including EINECS and CAS numbers;
Annex V has a list of general compounds exempted from registration.
Mixtures - preparations - solutions
Manufacturers and importers of mixtures, preparations and solutions have to analize the exact chemical composition, both qualitative and quantitative, of these mixtures. For each compound found should be checked whether the treshold of 1 tonne per annum is surpassed or not.
Examples:
- - paint (based on organic solvents)
- - cement
- - glue
- - ink
- - nail polish
- - thinner, white spirit, terpentine
- - ammonia (solution in water)
Articles - products
Every article (product) needs to be checked on its chemical composition.
Products which contain compounds which are intended to be released from the product are especially important.
Examples:
- - ink in ballpoints, fountain pens, cartridges
- - toner in cartridges for printers, copiers
- - spray cans with paint, hair spray, perfume, after shave, deodorant, etc.
- - odorants, fragrants in air refreshing units, clothing
For all articles that contain substances that, at normal use, will not be released, has to be checked:
1. whether the suppliers meet all REACH obligations.
(if this is not the case, then your own company may be in jeopardy soon!!)
2. whether they contain any Substances of very high concern (SVHC), like:
- fire retardants (e.g. brominated flame retardants)
- plasticizers (e.g. ftalates)
- soot in car tires
- mercury in thermometers
- lead, cadmium in batteries
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