APC offers you a full service
so you can easily meet your REACH obligations
while respecting the ECHA deadlines
Processes:
- Pre-registration is a process which allows registrants to benefit from transitional arrangements which allows a later full registration date.
- For products manufactured or imported into Europe in quantities greater than 1 tonne before pre-registration took place from 1st June 2008 until 1st December 2008.
- For substances that later meet these requirements it is possible to complete a late pre-registration.
- Failure to pre-register a substance before the closing date means it will have to be taken off the market until it is fully registered.
- Full registration takes place on a staggered basis as long as the chemical has been pre-registered.
1st December 2010 >1000 tonnes pa >100 tonnes pa R50/53 >1 tonne pa CMR category 1 or 2 1st June 2013 100 to 1000 tonnes per annum 1st June 2018 1 to 100 tonnes per annum - For substances with quantities of greater than 1 tonne per year, a technical dossier is required containing basic physc chem., tox and environmental tests, classification, uses and safety information of the substance.
- In addition, for substance with quantities of greater than 10 tonnes per year, further testing is required and a Chemical Safety Report needs to be submitted along with this technical dossier, documenting the hazards and classification, and whether the substance is bioaccumulative, persistent and toxic.
Services offered by APC
- Advice on REACH obligations
- Pre-registration of phase in substances
- Only representative
- Third party representative
- SIEF/consortia representation
- SIEF/consortia management
- Full registration of substances
- Data gap analysis
- Support and advice on testing strategies
- Study placement and monitoring
- IULCID5
- Preparation and defence of the dossiers required for registration
- Chemical safety assessment and report
- Exposure scenarios modeling
- QSAR modelling
- Classification and labeling chemicals
What a Technical Dossier includes
- Identity of the manufacturer/importer
- Identity of the substance and information on the manufacture and use of the substance
- Classification and labelling of the substance
- Guidance on its safe use
- Robust study summaries of the information on the intrinsic properties of the substance derived from applying Annexes VII to XI;
- An indication as to whether the information on manufacture and use, the classification and labelling, the robust study summaries and/or, if relevant, the chemical safety report has been reviewed by an assessor
- proposals for further testing, if relevant
- Substances registered in quantities of 1 to 10 tonnes require the dossier to also contain exposure related information for the substance (main use categories, type of uses, significant routes of exposure).
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