Originally adopted in 2006 the EU regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (1907/2006) has changed the way governments around the world approach chemical regulation and the information that suppliers need to provide to bring chemicals to market in the EU.
Substance Identification
REACH has harmonized the requirements for identifying substances placed on the market within the EU. All substances placed on the market at 1 tonne/year or more must be registered and that registration must include the spectral and analytical results used to identify the substance both qualitatively and quantitatively (it must be shown that what is registered is the same as what is placed on the market).
Hazard Based Approach
REACH adopted a hazard based approach to chemical control. Substances which are shown to be Carcinogenic, Mutagenic or Toxic to Reproduction (CMR), or substances which are Persistent, Bioaccumulative and Toxic or substances which have hazards of equivalent concern such as sensitization may be required to be authorized before use.
Other substances may have restrictions placed on their uses such as maximum % or mg/kg content in certain articles or mixtures or not being placed on the market in certain forms.
Risk Assessment
REACH has built upon the existing risk assessment framework used in the EU. REACH harmonized the methods for both undertaking and evaluating a risk assessment of a chemical. Older risk assessment models were updated and combined into new tools to make risk assessment easier and more standardized.
REACH mandates two separate fees for chemical registration. The first fee is payable to the lead registrant of the chemical for a share of the cost it took to register, The second fee is payable to the European Chemicals Agency (ECHA) for evaluating the registrants submission.
Think of this as a licensing fee to use the hazard data owned by the Lead registrant as well as a share of the cost it took to prepare the registration.
Hazard data can only be included in this fee for the first 12 years after submission, after this period the data can be used freely.
A share of the cost the total cost to prepare the registration dossier can also be charged by the lead registrant.
New registrants (joint registrants) can only be charged for the data they need for their registration. Due to the tiered approach REACH has adopted this means that Letter of Access costs for 1-<10 tonnes/year of supply are the lowest with costs increasing at each following tonnage band.
There is no mandatory reduction for SME companies on the Letter of Access fee. All companies must pay an equal fee.
This is the standard fee that ECHA charges for evaluating each submission. Fees are listed in the Fee regulation listed on the ECHA website.
Reductions are provided for SME companies on this fee.
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