Spotlight on Regulatory Updates
What You Need to Know
REACH Dossier Preparation Safety Assessment Substance Evaluation
A chemical safety assessment is required for any substance manufactured or imported at 10 or more tonnes per year, including an exposure assessment and risk characterisation for all identified hazards. The assessment needs to cover the whole of the life cycle of the substance. In order to achieve this, ECHA recommend that you co-operate with...
REACH Authorisation Deadlines-Act Now
2013 sees the first deadlines under the Authorisation program of REACH. Uses of substances that are listed on Annex XIV of REACH will be subject to a system of pre-approval otherwise called Authorisation. Companies using these substances must apply to the European Chemicals Agency (ECHA) by the Latest Application Date (see the table below) for...
What does a 2013 REACH Registration Deadline and Victory have in Common?
With 2013 registration deadline fast approaching, companies are busy preparing for the 31st of May 2013 registration deadline for phase-in substances greater than 100 tons per year. What will distinguish those registrants that are successful and those that are struggling to organize their registration and met the tight timeline – Project Management. So you know...
Chemical registration- 2013 duties under REACH
If you have chemical registration 2013 duties under REACH, then you need to know what you should be doing and by when. When talking about the need to register, attention generally focuses on the need for data review, new testing, deciding on classification and filling in all those fields in IUCLID. Even when considering the...
REACH Registration Dossier:What’s in a Public Name?
In previous blogs we have discussed confidentiality and dissemination of registration dossiers. This blog will continue on that theme and focus on confidentiality claims of the IUPAC name and what is a public name under REACH. Does your substance qualify for confidentiality of its IUPAC name? In accordance with REACH Article 119 (Electronic Public Access)...
How do toxicologists assess a substance’s behaviour in water
The purpose of this communication is to address how substances are classified for effects in the aquatic environment. The first step in building a registration dossier (to fulfil the ‘R’ part of REACH) is to carry out lab testing on the substance in a GLP environment. Annex VII of REACH lists the twenty two lab...
REACH Next Enforcement Targets:Non-EU companies take note!
Ramped up enforcement is planned for EU Importers around REACH registrations and Only Representative as part of the Ref-3 Enforcement Project. Plus increased assessment and scrutiny of reduced registration dossier for intermediates is in full swing and will eventually include completion of on-site assessments by Member States. Ref-3 is the third in a series of...
EU REACH REGISTRATION: Size is everything
There are 20 million Small and Medium Size Enterprises (“SMEs”) in the EU representing 99% of the total number of businesses. To ensure that this important sector is not unduly burdened by REACH, certain costs are reduced. Most notable is the cost for submission of jointly submitted Registration Dossiers to ECHA. Costs are reduced 30%,...
Substance Sameness for the 2013 REACH Registration deadline
ECHA recently presented Substance Sameness for REACH Registrationa webinar outlining the importance of substance identification and sharing of data for the 2013 registration deadline. While this is a very pertinent issue for companies that have a registration deadline for a phase-in substance in 2013, it also has consequences for companies who do not have an...
Applying for REACH Authorization
Find out what it takes to apply for substance authorization under REACH. Get insight into the committee’s opinions and find out about important dates to remember. Applicants information ECHA have conducted an analysis of what is confidential business information and what can be publically disseminated which is presented below: A brief description of the use...
REACH Dossier Preparation: Safety Assessments & Substance Evaluation
A chemical safety assessment is required for any substance manufactured or imported at 10 or more tonnes per year, including an exposure assessment and risk characterisation for all identified hazards. The assessment needs to cover the whole of the life cycle of the substance. In order to do this, ECHA recommend that you co-operate with...
Dossier Evaluation: What ECHA wants to see in your REACH Dossier
Below are the key issues which became apparent during the series of presentations at the European Chemicals Agency (ECHA) 7th Stakeholders’ Day on the key topic of Evaluation. Key messages from the presentations on the REACH registration process were covered last week in “5 key issues Registration issues from ECHA’s 7th stakeholder day” and authorization...