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Chemical Substance Registration

What is EU REACH?

EU REACH (the European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals) is a regulation of the European Union that requires the evaluation and authorisation for the registration in accordance with the hazards and distribution volumes of all chemical substances(mixtures and products containing chemical substances) manufactured or imported over one ton per year and went into effect as of June 1, 2007.

Manufactures and importers must register risk information of chemical substances manufactured or imported over one ton a year in the EU, and the European Chemical Agency and the EU member nations evaluate the risk of substances along with their registration documents. Based on the registration information, chemical substances likely to pose a risk are required to be strictly regulated by being assigned to restriction or permission, and ultimately alternative substances are required to be devloped accordingly.

EU REACH Registration Procedure

REACH 이행절차
  1. 1. REACH 발효 [2007.6.1]
  2. 2. 사전등록 [2008.6.1~12.1]
  3. 3. 등록
  4. 4. 평가
  5. 5. 허가/제한

Substances or products subject to EU REACH

REACH 적용 대상물질(제품)
Category Substances
Substances subject to Registration Substances: substances over one ton per year
Mixtures: at least one ton per year of substances contained in mixtures
(except substances already registred for the same uses by upper suppliers)
Articles: at least one ton per year of substances intentionally discharged from articles
(except substances already registered for the same uses by upper suppliers or other registrants)
Substances eligible for exclusion from registration
  • - Medicinal Products (Regulation (EC) No.726/2004)
  • - Food additives (Regulation (EC) No.178/2002)
  • - Flvourings in foodstuffs (Commission Decision 1999/217/EC)
  • - Additives in feedingstuffs (Regulation (EC) No.1831/2003)
  • - Animal nutritions (Council Directive 82/471/EEC)
Substances eligible for exemption from registration
  • - Annex IV
  • - Substances created by chemical reactions due to the exposure to environmental factors
  • - Substances created by chemical reactions accidently occurring during storage
  • - Substances created by chemical reactions occurring in final usage
    e.g. chemical reaction products by antioxidants, fillers, dehydration
  • - By-products that cannot be sold or imported solely
  • - Hydrate or hydrate ion which is a mixture of a previously registered substance and water
  • - Products created in their natural state (e.g. ore, natural gas, carbon, crude oil)
  • - Basic substances already known for their hazards and risks (e.g. hydrogen, oxygen, etc.)
  • - PRORD substances used for R&D (Temporarily exempted substances)

'How to respond to EU REACH’s great ripple effect

As a principle that no-registered substances can't be manufacturered or imported in the EU' (No Data, No Market), EU REACH grants the legal responsibilities to manufacturers and importers within the EU. As EU REACH came into effect, no-registered substances and products containing no-registered substances haven't been allowed for importation and manufacture within the EU. REACH, beyond the simple environmental issues, is bringing a tremendous influences on trade transactions between nations and further on product competitiveness of companies. In particular, as environmental regulations are diversified and strengthened, it is time to focus on a question on how to respond to the environmental regulations cost-effectively, rather than who can respond to the environmental regulations.

EU REACH Time schedule

REACH has a phase-in period that allows companies to put some Acts into force accordingly.

REACH Time schedule
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R50/53 : very toxic to aquatic organisms

SVHC : Substances of Very High Concern

CMR (Carcinogenic, Mutagenic. Reproductive toxicity): carcinogenic, mutagenic or reprotoxic

  • - Substances relevant to EU Directive 67/548/EEC Annex I "Instructions for classification, packing, labeling of hazardous materials"

R50/53 (very toxic to aquatic organisms, may cause long term adverse effects in the environment)

  • - Substances relevant to EU Directive 67/548/EEC Annex I "Instructions for classification, packing, labeling of hazardous materials"

SVHC (Substance of Very High Concern)

  • - The European Chemicals Agency (ECHA) is scheduled to present the substancse relevant to SVHC in the first half of 2009
  • ※ Substances applicable to SVHC

Substances relevant to the SVHC (Substances of Very High Concern)

  • - CMR (Carcinogenic, Mutagenic, Reproductive toxicity) Category 1, 2
  • - PBT (Persistent, Bioaccumulative and Toxic) and vPvB (very persistent, very bioaccumulative)