ChemRegs Newsletter – September 2018

Government ‘No Deal’ Brexit Notice

As mentioned in our August Newsletter, the Government has published a series of technical notices for a contigency ‘no deal’ scenario for Brexit.

Technical Notice: ‘Regulating chemicals (REACH) if there’s no Brexit deal’ was published on 24 September and sets out how businesses producing, registering, importing or exporting chemicals would be affected if the UK leaves the EU in March 2019 with no deal.

In a bid to ensure continuity for business, the Government would:

• Carry across existing REACH registrations held by UK-based companies directly into the UK’s replacement for REACH, legally ‘grandfathering’ the registrations into the UK regime.
• Set up a transitional light-touch notification process for UK companies importing chemicals from the European Economic Area (EEA) before the UK leaves the EU that don’t hold a REACH registration. This would reduce the risk of interruption in supply chains for companies currently relying on a registration held by an EEA-based company. This would mean that those UK companies could continue to buy those chemicals from the EEA without any break.
• Carry into the UK system all existing authorisations to continue using higher-risk chemicals held by UK companies.

The Government advises that UK firms need to take the following action:

• Businesses with existing EU REACH registrations being automatically grandfathered into the UK regime or authorisations would have to validate their existing registration with the UK authority (the HSE), open an account on the new UK IT system and provide some basic information on their existing registration within 60 days of the UK leaving the EU. This IT system is being tested with a range of different users so that it is ready to support registrations of chemicals in the UK from March 2019.
• Companies with grandfathered registrations would have two years from the day the UK leaves the EU to provide the UK authority (the HSE) with the full data package that supported their original EU registration and is held on the ECHA IT system.
• Businesses that imported chemicals from the EEA before the UK leaves the EU (but who did not have an EU REACH registration), would need to notify the UK authority and provide some basic data on the chemicals within 180 days of the UK leaving the EU, instead of having to undertake a full registration immediately. This would be an interim arrangement for those importers and they would need to move to full registration at a later date following a review of this approach.
• Importing businesses would be responsible for identifying appropriate risk management measures and recommending them to their customers.

Businesses wishing to place new chemicals on both the EEA and UK markets, in a ‘no deal’ scenario, would have to make two separate registrations, one to ECHA and one to the UK. The information and data package needed would be the same for both.

This Technical Notice can be seen here https://www.gov.uk/government/publications/regulating-chemicals-reach-if-theres-no-brexit-deal/regulating-chemicals-reach-if-theres-no-brexit-deal

The other notices can be seen here https://www.gov.uk/government/collections/how-to-prepare-if-the-uk-leaves-the-eu-with-no-deal

The Government has also prepared a briefing paper where it outlines the Government’s preferred approach to seek an agreement with the EU on a form of associate membership of the ECHA, rather than a no deal.

Other News

The Health and Safety (Amendment) (EU Exit) Regulations 2018

The government has issed draft proposols for regulations to ensure that European Union (EU) derived health and safety protection will continue to be available in domestic law after the UK has left the EU.

The Health and Safety (Amendment) (EU Exit) Regulations 2018 have been made under section 8 of the EU (Withdrawal) Act 2018 (EUWA), which gives power to address deficiencies in health and safety legislation arising from the exit of the UK from the EU. This instrument amends provisions which will for example, become inappropriate or redundant.

The draft proposals will amend 11 sets of regulations and one directly acting EU regulation and includes changes to the Control of Major Accident Hazards Regulations 2015 (COMAH), the Control of Substancees Hazardous to Health Regulations 2002 (COSHH) and the Genetically Modified Organisms (Contained Use) Regulations 2014.

The Control of Major Accident Hazards Regulations 2015 15 are amended to remove requirements to provide information to and advise Member States, report and provide information to the European Commission, which will no longer be appropriate once the UK leaves the EU. A new definition of “international organisation” is also inserted by these Regulations for consistency under the domestic regime.

The Control of Substances Hazardous to Health Regulations 2002 prohibit the import into the UK of certain substances and articles from outside the European Economic Area (EEA). Currently the regulations use the term “another Member State” implying that the UK is also a Member State. From exit day, the reference therefore needs to be changed to “a Member State” in order to continue the prohibition of importation of the relevant substances and articles from outside the EEA into the UK.

The COSHH Regulations also allow HSE to make exemptions, by a certificate in writing, from the prohibitions imposed for certain substances. ‘The Executive’ is defined in the regulations as the HSE. Currently, these exemptions are only permitted to the extent allowed by article 9 of Directive 98/24/EC 19. Article 9 sets out the circumstances in which exemptions may be granted and the information to be provided by the employer making the request. Article 9 makes reference to powers afforded to ‘Member States’; after exit in order for article 9 to still apply references to ‘Member States’ need to be read as meaning ‘the Executive’.

The Genetically Modified Organisms (Contained Use) Regulations 2014 are amended to remove a redundant reference and to amend requirements to notify EEA States and report to the EU which will no longer be appropriate once the UK leaves the EU.

The Regulations and the Explanatory Memorandum can be found at https://www.gov.uk/eu-withdrawal-act-2018-statutory-instruments/the-health-and-safety-amendment-eu-exit-regulations-2018

Significant Changes and Amendments to the IATA 60th Edition (2019)

IATA has published a list of the significant changes and amendments in the next edition of the Dangerous Goods Regulations for air transport due to come into force from 1 January 2019.

The 60th edition of the IATA Dangerous Goods Regulations incorporates all amendments made by the ICAO Dangerous Goods Panel in developing the content of the 2019–2020 edition of the ICAO Technical Instructions as well as changes adopted by the IATA Dangerous Goods Board.  The full list is available from here but a summary is given below:

General

Replacement of most instances of the word “risk” by the word “hazard”. The changes reflects the increasing use of safety management systems where “risk” is the likelihood of an event combined with the severity of the outcome, whereas hazard is used to identify the inherent properties. So, for example a substance may have a “subsidiary hazard”, not a “subsidiary risk”.

1.5—Training Requirements

Examples have been added to provide an explanation of the 3-month “window” for recurrent training and the application of the original training expiry.

2.3—Dangerous Goods Carried by Passengers or Crew

New text has been introduced to clarify that the most appropriate entry that describes the item must be used and where an article contains more than one item of dangerous goods, all applicable provisions must be met. In addition, where a passenger’s carry-on baggage cannot be accommodated in the cabin, the operator must verify with the passenger that the carry-on baggage item does not contain dangerous goods forbidden in checked baggage.

Radiopharmaceuticals contained in a person following medical treatment and energy efficient lamps in retail packagings are now not subject to these Regulations, consequently the provisions applicable have been deleted.

The provisions applicable to battery-powered mobility aids have been revised to simplify and standardise the requirements for loading in an aircraft.

2.8—State and Operator Variations

There are a number of additions, deletions and amendments to variations submitted by States and operators.

3—Classification

Clarification on the classification of ammonium nitrate fertilizers has been added and the classification of infected animal material has been deleted.

Common throughout all the new editions of the transport regulations is that significant changes to the provisions for the classification of corrosive substances and in particular the methods to assign packing groups to mixtures have been made. These changes reflect the work of the UN Subcommittee with the GHS Subcommittee to better align the classification provisions for transport for Class 8 substances with those for supply and use.

4.2—List of Dangerous Goods

Amendments to the List of Dangerous Goods include:

• The addition of twelve new UN numbers, UN 3537 to UN 3548, that have been assigned to articles containing dangerous goods in Classes 2, 3, 4, 5, 8 and 9 and Division 6.1;
• Modification to the entries for UN 3316—Chemical kit and First aid kit to delete reference to packing groups II and III. The shipper must assign the appropriate packing group based on the most restrictive packing group in the kit as specified in special provision A44;
• The addition of a new entry, UN 3536, Lithium batteries installed in cargo transport unit. This entry is to address multi modal containers with installed lithium ion batteries, battery management systems and other electronics that function as a large fixed-base battery;
• The emergency response drill code, ERG Code shown in column N, for all lithium battery entries has been changed from “9FZ” to “12FZ”. This reflects a change agreed by the ICAO DGP to identify that the inherent hazard for lithium batteries is not “9—No general inherent risk” and a new drill number “12—Fire, heat, smoke, toxic and flammable vapour”, was adopted.
• The addition of a new entry, UN 3535, Toxic solid, flammable, inorganic, n.o.s.

4.4—Special Provisions

Various special provisions have been revised and new one shave been added.

5—Packing

Various packing instructions have been revised.

6—Packaging Specifications and Performance Tests

Subsection 6.4.2 has been revised to bring in reference to new ISO standards and also to identify the period during which the ISO standards may be applied for manufacture and also after which time the standards may no longer be used.

7—Marking & Labelling

A note has been added to draw attention to the correct application of GHS pictograms on packages.

The specification for hazard labels has been revised to remove the requirement for the outside line to be a minimum of 2 mm in thickness.

Clarification has been added that the new Class 9 lithium battery hazard label must not have any text in the bottom half other than the class number “9”.

Lithium battery handling label—The provisions that previously existed in 7.2.4.7 and Figure 7.4.H have been deleted as the lithium battery handling label is no longer valid in air transport.

8—Documentation

Notes have been added to identify that Shipper’s Declaration form in the format as shown in the 59th edition of the DGR remain valid until 31 December 2024. These notes have been added as the design of the Shipper’s Declaration form has been revised to replace “subsidiary risk” by “subsidiary hazard” in association with the class or division. The form has also been modified to remove reference to the title of the signatory and the place that the document was signed. These requirements were removed in the 58th edition of the DGR, but the form had not been revised as these changes were not considered significant enough to warrant a change to the form. However, with the change of risk to hazard it was thought appropriate to make changes to the form.

9—Handling

The information required on the written information to the pilot-in-command has been revised to also require that the date of the flight be shown.

Appendices

Appendix A—There are a number of changes to the defined terms in the glossary.
Appendix B—In Appendix B.2.2.4 new Cargo IMP codes have been added for UN 3090, Section II of PI 968—EBM and UN 3480, Section II of PI 965—EBI. These two new IMP codes facilitate the differentiation of Section II lithium batteries (UN 3090 and UN 3480) from those lithium batteries in Section II packed with equipment or contained in equipment (UN 3091 and UN 3481), which are currently assigned to ELM and ELI respectively.
Appendix C—There are revisions to the list of self-reactive substances in Table C.1 and organic peroxides in Table C.2.
Appendix D—Contact details for competent authorities have been updated.
Appendix E—Changes have been made to the list of UN Specification Packaging Suppliers (E.1) and the
Package Testing Facilities (E.2).
Appendix F—The list of Sales Agents (F.2), IATA Accredited Training Schools (F.3—F.5) and IATA
Authorised Training Centres (F.6) have been revised.
Appendix H—The content of 1.5 in Appendix H has been revised to reflect the changes to the provisions for dangerous goods training as agreed by the ICAO Dangerous Goods Panel for competency-based training. At this time the new provisions will be adopted with effect 1 January 2021 with a 2-year transition. Appendix H also contains extensive guidance material for competency-based training. This guidance material is draft and industry is invited to review and comment as appropriate.

For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk