Brexit and Chemicals Regulation
08.30 Welcome Coffee
17.00 End of Day 1
16.30 End of Day 2
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
- 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