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Ready for REACH?

EU chemical control legislation is undergoing a major overhaul with the establishment of REACH reach logo(Registration, Evaluation and Authorisation of Chemicals). This will impose new regulatory requirements on both existing and new chemical substances, and affect all sectors of the supply chain.

Aims of REACH

REACH will place a duty upon companies that produce, import or use chemicals to access the risks arising from these activities and to take the necessary measures to manage any risks identified. Data have to be shared to reduce any animal testing.

Registration of information on the properties, application and safe use of chemical substances will be an integral part of the new system. Data requirements for registration are dependant on the volume produced and on the likelihood of exposure to humans and the environment.

A phase-in system lasting up to 11 years is planned. Higher tonnage substances would require the most data and would have to be registered first; lower tonnage substances would require less data and be registered later.


With a wealth of experience gained under the existing chemical legislation, SafePharm is well placed to provide a complete services to enable companies to meet the challenge of the REACH program. We aim to get chemicals through the increasingly complex web of legal and regulatory requirements as efficiently as possible and help our clients to develop new products quickly and cost effectively, without compromising safety.

Chemicals of Concern

 

Chemicals of highest concern will be subject to more stringent controls under an authorisation regime and hence will be registered early. This includes carcinogens, mutagens and reproductive toxicants (CMRs); persistent, bioaccumulative and toxic substances (PBTs) and very persistent, very bioaccumulative substances (vPvBs). Other substances of concern, such as endocrine disrupters, will be included on a case-by-case basis within the authorisation system. All substances subject to authorisation will require approval for a specific use, with decisions based on a risk assessment and consideration of socioeconomic factors.

 
Not Every Study Needed
 

reachREACH is likely to make extensive use of surrogate data, by predicting properties from chemical structure, other measured properties or testing analogues. This process can be linked with making use of data waivers justified on the grounds of low exposure. Making maximum use of existing published data, surrogate data and waivers will allow for 'intelligent toxicity testing' to minimise the cost and animal usage, yet provide information to assess the hazardous properties and conduct a risk assessment. As a consequence, testing is by no means a routine 'box-ticking' exercise and will require expert involvement. Risk assessment is central to REACH and based on our experience with notification of new chemicals and registration of biocides, preliminary risk assessments are likely to be pivotal in deciding whether to proceed with registration under REACH.

Our Registration staff have extensive experience with:

  • Risk Assessments
  • Negotiating with Regulatory Agencies
  • Use of Surrogate Data (Literature, Rea-Across, SAR etc)
  • Dossier Preparation
  • Chemical Safety Reports

By conducting preliminary Risk Assessments on your products, we can help you determine your obligations under REACH and formulate a testing strategy to save time and money in the process.

 

 
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