28 - 29 June 2021
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Intro / Registration / Agenda / Location

Course Leader

Peter Douben is Director of REACHWise, a London based consultancy aimed at assisting companies with their implementation of REACH, CLP and associated legal duties.

REACHWise has a range of clients in different sectors of industry, and their role under REACH ranges from manufacturers of both existing and totally new substances, importers as well as downstream users. It is involved in SIEFs and consortia, and carries out Chemical Safety
Assessments and prepares CSRs with Exposure Scenarios for companies. With the progressive implementation of GHS, many companies turn to REACHWise for support to obtain compliant Safety Data Sheets in different languages for different markets. It continues to provide these
services under EU REACH and UK REACH. It also acts as an OR under UK REACH.

Before REACHWise, Peter was Head of Environmental Protection in Unilever and served on many industry bodies in Europe and North America. Then he was Director REACH/Chemicals Policy in Cefic, the European Chemical Industry Council, during which he was responsible
for the implementation of REACH. He has a University degree from the University of Wageningen, The Netherlands, and a PhD in ecotoxicology, based on a collaboration between Wageningen University and the Natural Environment Research Council, funded by the EEC, the
forerunner of the EU, with additional financial support from the British Council.
Peter has contributed to many conferences including some organised by Chem-Academy and has given a number of highly successful trainings and workshops.



Day 1:
09.00 Start, 17.00 End of Day 1

Day 2:
08.30 Start, 16.30 End of Day 2


Content of Course

The transition period for the United Kingdom’s withdrawal from the European Union came to an end on 31 December 2020. While having avoided a hard Brexit, from January 2021 onwards the UK operates its own version of REACH. But REACH, and related legislation, has been replicated in the UK with the necessary changes to make it operable in the new situation. The key principles of the EU REACH regulation have been retained. (2021, March 18th)

Any set of circumstances requires intensive preparation. The chemicals regulations arena is not immune from this given the close interconnection of different supply chains across the EU member states and the UK. Whatever the outcome of future negotiations, companies from the EU will then no longer have unlimited “regulatory free” access to the United Kingdom’s market and vice versa. This implies that there will be a potentially disrupting impact on supply chains for manufacturers, downstream users, and article producers unless adequate preparation and action is undertaken.

The workshop will discuss the consequences on companies according to the roles companies may find themselves in, and it will also show how to drive precautionary measures for Brexit related challenges. As usual with the courses led by REACHwise there will be a mix of taught elements, exercises and exploration and discussion of company situations.

Roles under REACH and Potential Changes after the Brexit

ECHA urges companies to know their role in the various supply chains in order to understand both REACH obligations and the potential impact by the Brexit. It is the starting point of their support section on the Brexit.

Similarly the UK’s Health and Safety Executive in coordination with Defra provides information.

The workshop will consider the new circumstances from the viewpoint of EU based companies with UK connections in their supply chain, as well as for UK based companies with EU connections in their supply chain. At the same time especially the roles of Only Representatives become
interesting for both jurisdictions as these can be significant. Therefore the consequences will be explored; this also applies to ORs for non-EU and non-UK manufacturers.

The structure of the workshop is quite simple but leads to substantial tasks within product stewardship to make sure current and upcoming obligations are met.

Though expectations in the political dimension need to be dampened it is also worth having a closer look at Defra, the UK’s competent authority.

Defra is updating its website frequently with notes on how to prepare for access to the United Kingdom’s market. This information also indicates to what extent UK’s and the EU’s chemicals regulation will not only be based on common principles but also how the core elements resemble
each other.

• Roles under REACH (more or less currently but also in the future)
– EU-based manufacturer and UK-based manufacturer
– EU-based downstream user and EU-based downstream user
– Only Representative for manufacturers and formulators
• Obligations under REACH and what can cause additional requirements
• Impact on classification and labelling
• How to collaborate with ORs
• Outline of the upcoming chemicals regulation for the United Kingdom


Effects on Registrations, Evaluations, and Authorisations

The participants of the workshop will use the R, E, and A of REACH as a pattern to approach the checks they have to do in order to maintain their own portfolio. The workshop starts with the basic question on how to secure registrations in case the lead registrant is from the UK. How can
registrations be transferred to EU based companies? What will the costs be? And will your role probably change to being an importer, and if so – what are the consequences?

It makes sense to compare scenarios and assess various options deriving from them. If lead registrants do not transfer registrations to EU based legal entities complex scenarios unfold. The workshop participants will also have a closer look at the business impact, including the total costs.

• What to do if your substance is registered by a legal entity in the UK?
• Data sharing issues
• Joint registrations with UK manufacturers
– Letter of Access
– Negotiations with registrants and consortia
• Obligations of importers
• Challenges with evaluations
• Authorisations by UK manufacturers
• Chemicals under the PIC regulation
• Business impact of changes


Maintaining Market Access in the United Kingdom

Most companies will want to maintain their market access to the United Kingdom for obvious reasons. It’s an educated guess that the United Kingdom’s authorities will not reinvent the regulatory wheel. Still there are detailed questions to be dealt with: what data, what studies can be
used for UK registrations?

The delegates will elaborate on timelines, documents, and costs related to maintaining their business in the UK. Finally, they will work out a brief guideline on checking and preparing the portfolio for the new UK chemicals regulation, emphasizing the synergies from REACH related
data management.

• Data requirements for UK registrations
• Which data from EU registrations can (not) be used?
• Timelines and costs
• Dos and don’ts when working with Only Representatives
• Preparing the portfolio for the UK market: plan, do, check, act


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