REACH
REACHisthe abbreviation of the EU Regulation (REGULATION concerning the Registration,Evaluation, Authorization and Restriction of Chemicals). It was established bythe EU and implemented on June 1, 2007. It is a proposal for regulationsconcerning the safety of the production, trade and use of chemicals aimed atprotecting human health and environmental safety, maintaining and enhancing thecompetitiveness of the European Union's chemical industry, and developinginnovative capabilities for non-toxic and harmless chemicals, preventing marketdisruption, increasing transparency in the use of chemicals, and promotingnon-animal experiments. In pursuit of sustainable social development.
REACHDirective requires that chemicals imported and manufactured in Europe must bebetter and simpler identified to ensure environmental and human safety througha comprehensive set of procedures, such as registration, assessment,authorization and restriction. Unlike the RoHS directive, REACH covers a muchbroader range of products and manufacturing processes in virtually allindustries, from mining to textiles and clothing, light industry, electronicsand so on. REACH requires manufacturers to register about 30,000 chemicals ineach product - and to measure their potential public health hazards. REACHestablishes the idea that society should not introduce new materials, productsor technologies if their potential hazards are uncertain. On December 18, 2006,the European Parliament and the Council of the European Union formally adoptedthe Regulation on Registration, Assessment, Authorization and Restriction ofChemicals (REACH Regulation), which regulates the preventive management of allchemicals entering the markets of 28 EU member states. The regulation came intoeffect in June 1, 2007 and began in June 1st of next year. The authority is theEuropean Chemicals authority (ECHA).
Thisstandard requires that any kind of highly concerned substance (SVHC) with anannual usage of more than one ton should not exceed 0.1% of the total weight ofthe goods. Otherwise, it is necessary to fulfill a series of cumbersomeobligations such as registration, notification, authorization, etc. Inaddition, the Regulation incorporates the original Directive Set 76/769/EC intoAppendix 17, thus imposing very stringent restrictions on the use of a range ofchemicals that are harmful to human beings and the environment.
Accordingto the REACH code, one of the following substances can be regarded as highlyconcerned substances (SVHC):
CMR: carcinogens,mutagens, toxic substances to the reproductive system;
PBT:persistent, bioaccumulative toxic substances.
vPvB: permanentand high bioaccumulation substances;
Substances that may have a serious impact onthe human health environment;
Requirements：
One of the major elementsof the REACH regulation is the requirement to communicateinformation on chemicals up and down the supplychain. This ensures that manufacturers, importers, and also their customersare aware of information relating to health and safety of theproducts supplied. For many retailers the obligation to provide informationabout substances in their products within 45 daysof receipt of a request from a consumer isparticularly challenging. Having detailed information on the substances presentin their products will allow retailers to work with the manufacturing base tosubstitute or remove potentially harmful substances from products. The list ofharmful substances is continuously growing and requires organizations toconstantly monitor any announcements and additions to the REACH scope. This canbe done on the European Chemicals Agency's website.
Registration
A requirement is tocollect, collate and submit data to the European Chemicals Agency (ECHA) on thehazardous properties of all substances (except Polymers and non-isolatedintermediates) manufactured or imported into the EU in quantities above 1 tonneper year. Certain substances of high concern, such as carcinogenic, mutagenicand reproductive toxic substances (CMRs) will have to be authorised.
Chemicals will beregistered in three phases according to the tonnage of the substanceevaluation:
More than 1000 tonnes ayear, or substances of highest concern, must be registered in the first 3years;
100-1000 tonnes a yearmust be registered in the first 6 years;
1-100 tonnes a year mustbe registered in the first 11 years.
In addition, industryshould prepare risk assessments and provide controls measures for using thesubstance safely to downstream users.[9]
Evaluation
Evaluation provides ameans for the authorities to require registrants, and in very limited casesdownstream users, to provide further information.
There are two types ofevaluation: dossier evaluation and substance :
Dossier evaluation isconducted by authorities to examine proposals for testing to ensure thatunnecessary animal tests and costs are avoided, and to check the compliance ofregistration dossier with the registration requirements.
The relevant authoritiesperform substance evaluation when there is a reason to suspect that a substancepresents a risk to human health or the environment (e.g. because of itsstructural similarity to another substance). Therefore, all registrationdossiers submitted for a substance are examined together and any otheravailable information is taken into account.[9]
Authorisation
The REACH proposal sets upa system under which the use of substances with properties of very high concernand their placing on the market can be made subject to an authorisationrequirement.
This authorisationrequirement ensures that risks from the use of such substances are eitheradequately controlled or justified by socio-economic grounds, having taken intoaccount the available information on alternative substances or processes.
The Regulation enablesrestrictions of use to be introduced across the European Community where thisis shown to be necessary. Member States or the Commission may prepare suchproposals.
