- Maintain registrations through updates
- Learn about the most important regulatory demands on registrations
- Know more about DNEL / PNEC impact and making changes if revisions needed
- Get to know more the dossier requirements and supporting documents
- Understand Mechanics of updates in IUCLID
- Be aware of CoRAP and higher-level reviews
REACH is the acronym for the new European Union regulation covering the Registration, Evaluation, Authorisation and restriction of Chemicals. After the initial phase of REACH registrations in 2010 and 2013, many lessons have been learned. However, for many registrants, the 2019 deadline for substances manufactured or imported in the range 1 – 100 will be their first experience with registration under REACH.
Objective of the event
Even after registration is complete, the work continues. It is necessary to maintain registrations through updates, both spontaneous (voluntary) and enforced (request from ECHA).
There has been criticism at the quality of many dossiers and in hindsight, improvements can be made. This may be gross errors such as classifications or data input mistakes (wrong units, decimal points, typos etc), but the concerns raised by ECHA relate mainly to the quality of justifications used to support test waivers or to support read-across.
ECHA have also made many requests for new testing in response to test proposals or where waivers were questioned. There has also been a lot of questions on substance identity (especially UVCB) where a single substance may need splitting into two or more substances.
Exposure and uses have also been questioned and although most cases relate to intermediates, many registrants are under pressure to make updates to include new customer uses.
There is also a community rolling action plan (CoRAP) to review dossiers; this is aimed at substances considered to be high risk (either hazardous, high exposure or insufficient data to conclude safe use.
This event will cover the basic regulatory demands on registrations, specifically covering areas where experience to date has shown that either errors were made in the original submissions, of where new information will lead to the need to make updates.
The programme is aimed at those who have made or need to make a registration, either as ‘Lead Registrant’ or as part of a joint registration. It is expected that those attending will be familiar with REACH and will have a reasonable knowledge of the data used for hazard and risk assessment.
Mark Selby has worked in the area of regulatory science for over 20 years, starting with a UK-based speciality chemical manufacturer at the time that the EINECS list was closing. This background in industry provided a valuable insight into the problems facing manufacturing organisations with limited resources and tight schedules, but which needed to keep up with legislation.
Work surrounding chemical supply legislation and other regulatory testing led to contact with a multi-national Contract Research Organisation working mainly for the pharmaceutical industry and Mark was employed by them in 1989 to set up a consulting service to cover chemical supply legislation. Work also included providing advice to colleagues to ensure that regulatory testing for chemical supply was performed effectively and that laboratory staff had access to the correct equipment and test guidelines.
Working now as an independent consultant, trading as Denehurst Chemical Safety Ltd, Mark advises industry on the use of data for classification and labelling, the testing of chemical products and submission processes in support of EU chemical supply legislation. This includes a substantial amount of writing and training work, including lecturing for all levels of industry which aims to link the regulatory constraints with practical solutions for producers and users of chemical products.
As well as a trainer for the CHCS (http://www.chcs.org.uk) and for the ETCIC REACH training at Hull University (http://www.etcic.com), Mark works with REACHReady (http://www.reachready.co.uk) as one of their advisors and trainers. Mark has also been involved with the European Commission funded ‘Twinning’ projects helping new EU Member States.
Recent work has included training and support for European Competent Authorities and ECHA foundation courses to help scientific and regulatory training of personnel working in various agencies.