ChemRegs Newsletter – September 2020
(Contains public sector information licensed under the Open Government Licence v3.0.)
UK REACH, GB CLP and BPR
2020 has been a memorable year and as it draws to a close so the Transition Period of Brexit also ends, meaning many changes to UK chemical laws.
UK REACH
At the end of the Transition Period the EU REACH Regulation will be brought into UK law under the European Union (Withdrawal) Act 2018.
REACH, and related legislation, will be replicated in the UK with the necessary changes to make it operable in context. However, the key principles of the EU REACH Regulation will be retained.
The independent chemical regulatory framework that will operate in the UK from the 1 January 2021, will be known as UK REACH and the Department for Environment Food and Rural Affairs (Defra) has published guidance on UK REACH on GOV.UK., which is shown below.
From 1 January 2021 the UK REACH and the EU REACH regulations will operate independently from each other. Companies that are supplying and purchasing substances, mixtures or articles to and from the EU/EEA and the UK will need to ensure that the relevant duties are met under both pieces of legislation.
UK REACH will maintain EU REACH’s aims and principles. These include:
- the “no data, no market” principle
- the “last resort” principle on animal testing
- access to information for workers
- the precautionary principle
The government intends to extend the deadlines for submitting data under UK REACH transitional provisions subject to scrutiny by parliament and the devolved administrations. The Defra guidance includes these extension dates rather than those currently provided in UK REACH legislation.
UK REACH for business
Under UK REACH, manufacturers and importers have a duty to register chemicals that access the UK market. GB-based companies currently registered with EU REACH will no longer be able to sell into the EEA market without transferring their registrations to an EU/EEA-based organisation.
Businesses must review their roles in the EU and UK REACH systems, and their current supply chains, as they will need to take certain actions to access the EU/EEA and UK markets.
Under the Northern Ireland Protocol, the process for Northern Ireland businesses moving goods to and from the European Union under EU REACHwill not change from 1 January 2021. Further guidance will be published for NI businesses moving goods into the GB market.
UK held registrations: ‘grandfathering’
EU REACH registrations held by UK-based companies will carry across directly into UK REACH, legally ‘grandfathering’ the registrations into the new regime.
UK-based holders of existing EU REACH registrations may continue the ‘grandfathering’ process by providing basic information to the Health and Safety Executive (HSE) by 30 April 2021.
Holders must complete the grandfathering process within 2, 4 or 6 years of 28 October 2021, depending on their Tonnage Band Deadlines.
The information UK-based holders need to provide will be the same or very close to what holders previously provided. Defra will publish any changes to the information needed before the end of 2020.
EU held registrations: UK downstream Users
UK downstream users (who do not hold an EU REACH registration) currently importing chemicals from an EU/EEA country need to ensure the substances they purchase are covered by a valid UK REACH registration.
Businesses currently relying on a registration held by an EU/EEA-based company can continue importing substances as they do now on 1 January 2021. They will need to take subsequent actions to ensure that the chemical is registered for UK REACH purposes.
These UK downstream users must notify the HSE using a Downstream User Import Notification (DUIN) of their intention to continue importing substances from the EU/EEA by 27 October 2021.
A new registration must then be submitted to the HSE within 2, 4 or 6 years of 28 October 2021. Alternatively, UK downstream users can encourage their EU/EEA supplier to appoint a UK-based Only Representative (OR), or change their source to a UK registered supplier.
It’s possible to submit DUINs if a chemical is covered by a registration held by an EU/EEA-based OR and then sold into the UK.
Tonnage band deadlines
Under UK REACH, deadlines for the full submission of data to underpin registration dossiers will be staggered over a period of 6 years. These deadlines start from 28 October 2021, the end of the DUIN submission period.
These bands have been set to ensure those chemicals manufactured or imported at high tonnage, and those substances with particularly hazardous properties are registered first.
The tonnage bands are:
| Deadline Post 28 October 2021 | Tonnage | Hazardous Property |
|---|---|---|
| 2 years from 28 October 2021 | 1000 tonnes or more per year | ● carcinogenic, mutagenic or toxic for reproduction (CMRs) – 1 tonne or more per year ● Very toxic to aquatic organisms (acute or chronic) – 100 tonnes or more per year ● Candidate list substances (as at 31 December 2020) |
| 4 years from 28 October 2021 | 100 tonnes or more per year | Candidate list substances (as at 27 October 2023) |
| 6 years from 28 October 2021 | 1 tonne or more per year |
Authorisations
As the UK will be operating an independent regulatory system, UK downstream users will no longer be able to rely on EU REACH authorisation decisions addressed to companies in the EU/ EEA from 1 January 2021.
All existing authorisations which have gone through the full authorisation process (and have a review date) will be recognised by UK REACH. This means that chemicals can continue to be used by UK companies who rely on these authorisations. New authorisation applications, and authorisations waiting for EU/ECHA approval, must be submitted to UK REACH.
EU market access for UK business
GB-based entities currently holding EU REACH registration can continue exporting substances or mixtures to the EU/and EEA markets by either:
- transferring their registrations to an EU/EEA-based entity
- supporting their EU/EEA-based importers to become registrants
GB-based entities currently holding EU REACH registrations also need a valid UK REACH registration to maintain access to the UK market.
The European Chemical Agency (ECHA) explain how to transfer your UK REACH registrations before 1 January 2021.
Under the Northern Ireland Protocol, the process for Northern Ireland businesses moving goods to and from the European Union under EU REACHwill not change from 1 January 2021.
Comply with UK REACH
The online service ‘Comply with UK REACH’ will go live on 1 January 2021. Businesses can use the service to:
- validate existing UK-held EU registrations (‘Grandfathering’)
- submit downstream user import notifications (DUIN)
- submit new substance registrations
- submit new product and process orientated research and development (PPORD) notifications
Businesses will need to contact the HSE to ensure that they:
- validate existing UK-held product and process orientated research and development (PPORDs), known as ‘grandfathering’
- provide information on any authorisation matter,including new authorisation application, grandfathering of existing authorisations, and downstream user notifications of authorised uses
Importing from the EU to the UK
EU/EEA based companies who import chemicals into the UK under UK REACH must ensure that they are covered by a valid UK REACH registration.
These companies can register the substance under UK REACH through a UK-based OR or an affiliate UK importer.
If the EU/EEA company takes on registration obligations through a UK-based entity, their UK customers will retain their downstream user status.
GB CLP
When the Transition Period ends on the 31st December 2020, the European Union Regulation for the Classification, Labelling and Packaging of substances and mixtures (EU CLP) will cease to apply in Great Britain (GB).
From the 1st January 2021, the EU CLP Regulation will be replaced by the standalone GB Classification, Labelling and Packaging of substances and mixtures Regulation (GB CLP).
GB CLP will adopt the United Nations Globally Harmonized System of the classification and labelling of chemicals (UN GHS) in a similar way to EU CLP. Once the Transition Period has ended, those CLP functions now carried out by ECHA and the European Commission will be carried out by HSE, with support from other government departments/agencies and the Welsh and Scottish Governments. Decisions will be taken by the Secretary of State with the consent of the Scottish and Welsh ministers. This means that GB-based businesses that supply the GB market with substances and mixtures will deal with HSE as the GB CLP Agency instead of ECHA.
The duties and obligations of GB-based businesses supplying the GB market include the following:
- GB-based manufacturers, importers and downstream users must classify substances and mixtures in line with GB CLP before they place them on the GB market;
- GB-based suppliers (i.e. manufacturers, importers, downstream users and distributors) must label substances and mixtures before they place them on the GB market to reflect the hazard classification; and
- GB-based suppliers (i.e. manufacturers, importers, downstream users and distributors) must package the substances and mixtures they place on the GB market safely and securely.
(At the moment, it looks like the mandatory poison centre notification and generation of a UFI for hazardous mixtures in the EU (required from January 2021) is not being adopted by GB CLP. The requirement to submit information about hazardous mixtures being placed on the GB market to the National Poisons Information Service (NPIS) is to be on a voluntary basis only).
In addition, as under EU CLP, there are obligations on GB-based suppliers to identify, examine and evaluate available scientific and information on substances and mixtures where it relates to the possible physical, health or environmental hazardous properties of those chemicals to ensure all the requirements of classification, labeling and packaging are fulfilled. From the 1st January 2021, suppliers must also comply with GB mandatory classification and labelling which replaces the EU harmonised classification and labelling (CLH) system in GB.
There are no changes to the requirements where CLP labelling may appear alongside those for transport. There are also no changes to the packaging requirements and the requirements for child resistant closures (CRC) and tactile warning devices (TWD) will remain in place.
Testing arrangements, including the prohibition of testing on humans or primates for the purposes of GB CLP, will still apply.
The duty to notify substances placed directly on the GB market, either on their own or in a mixture, will apply to GB-based manufacturers and importers supplying the GB market. Notification will be made to HSE as the GB CLP Agency, rather than ECHA. Notification of certain substances will be exempt; further guidance on such exemptions is provided in the CLP scenario table (PDF)- Portable Document Format .
A new website is currently under construction that will provide in-depth guidance on the new GB CLP regime. In the meantime, the following bullet points highlight the main changes under GB CLP:
- GB-based downstream users and distributors supplying the GB market that are currently supplied from the EU/EEA will become importers under GB CLP and will be obliged to undertake the full duties of an importer if these supply arrangements continue after 31 December 2020;
- GB-based businesses placing chemicals on the GB market will deal with HSE for specified GB CLP functions e.g. notifying classification and labelling of substances;
- HSE will undertake certain GB CLP competent authority functions, on behalf of the Secretary of State, the Scottish ministers and the Welsh ministers;
- Existing EU harmonised classification and labelling (CLH) for the named substances or groups of substances that appear in Part 3 of Annex VI of EU CLP, will continue to have legal effect in GB. From 1 January 2021, HSE will put in place new arrangements for GB mandatory classification and labelling (GB MCL). These arrangements will allow future new and revised classification and labelling to be proposed, considered in collaboration with the devolved administrations and given effect on the GB market. GB MCLs will be listed in the GB mandatory classification and labelling list;
- From 1 January 2021, GB will be free to make its own decisions about mandatory hazard classification and labelling, including whether or not to align with decisions made in the EU or other countries. Such decisions will be made by the Secretary of State with the consent of the Scottish and Welsh ministers.
- GB-based businesses will be required to use the new GB arrangements. This includes submitting information to the new GB notification database and referencing the GB mandatory classification and labelling list hosted and managed by HSE. Further information is provided in the CLP scenario table (PDF)- Portable Document Format .
- Responsibility for the classification, labelling and packaging of chemicals being exported to the EU from the GB will rest with the EU-based importer. The EU importer may therefore request details of the GB exported chemicals involved from the GB-based business.
BPR
After the transition period ends, Great Britain will put in place a regulatory framework for biocidal products. This will be done by retaining the Biocidal Products Regulation (BPR) and its subsidiary regulations in national law using the provisions of the EU Withdrawal Act. The national regime will reflect the current EU framework, but they will operate independently of each other. Amendments have been made to enable functions presently carried out in the EU to continue. Certain EU functions have been removed (e.g. on Union authorisations and mutual recognition) as they will no longer operate in a Great Britain only context.
This will ensure continued levels of protection for human health and the environment and provide certainty to businesses putting biocidal products on the market in Great Britain.
Implications for business
The Health and Safety Executive (HSE) will act as the competent authority for Great Britain on behalf of the Secretary of State and the Ministers in Scotland and Wales.
Companies wishing to apply for an active substance to be approved, or for a biocidal product to be authorised in Great Britain after the transition period ends will apply to HSE, instead of the European Chemicals Agency (ECHA). Active substance approvals and new biocidal product authorisations will be specific to Great Britain. Companies wishing to apply for active substance approvals or product authorisations in the EU-27, the European Economic Area (EEA) (Norway, Iceland and Liechtenstein), and Switzerland, will continue to apply to ECHA.
HSE will take on the functions that ECHA currently performs, where these are still relevant in Great Britain. For example, HSE will co-ordinate the active substance evaluation process for Great Britain, in liaison with the various administrations.
HSE will introduce its own processes and systems for receiving and processing applications. Companies will use these instead of ECHA’s systems when applying for an active substance approval, or product authorisation, and for other procedures under the BPR.
The way in which data can be submitted to HSE to satisfy the legislative requirements for BPR will be confirmed in due course.
Companies will need to submit information to HSE previously submitted to ECHA or other Competent Authorities
HSE will store the information and data required to support biocidal product authorisations and active substance approvals, replacing ECHA’s databases. To enable HSE to operate the biocides authorisation regime on a GB-only basis, companies will need to submit supporting data or other information to HSE that had previously been submitted to ECHA or other Competent Authorities.
This will be the same information as was previously submitted to the evaluating Competent Authority and HSE will not impose additional charges.
Authorisations and approvals valid in Great Britain will remain valid
If you hold a biocidal product authorisation that is valid in Great Britain, it will remain valid after 1st January 2021 until its normal expiry date. However, the authorisation holder will need to be established in the UK within one year (by 1st January 2022).
Active substance approvals will also remain valid until their normal expiry date, if the information originally provided to the evaluating authority is provided to HSE.
Ongoing applications
If you have a biocidal product application being processed by HSE when the transition period ends, HSE will, where possible, continue to process this to grant a national authorisation. However, HSE will need you to re-submit the information supporting the original application to enable it to complete its evaluation.
If you have an application being processed by another country in the EU, EEA or Switzerland as part of an EU-wide authorisation process (for example, a mutual recognition or union authorisation application) at the end of the transition period, you will need to resubmit your application to HSE if you intend to seek a national authorisation in Great Britain.
However, the date of your original application would be recognised for the purposes of meeting any application submission deadlines.
Article 95 list
A Great Britain version of the EU list of approved active substance suppliers (the ‘Article 95’ list) will be established. The list will mirror the EU list at the point the transition period ends and will operate the same way as the current EU list. Companies already on the EU list will be included in the GB list when the transition period ends.
To remain on this list, businesses will need to submit supporting information to HSE. This is the same information submitted to ECHA, for example, an active substance dossier or a letter of access to data held by HSE. Suppliers will also have to ensure they are established in the UK. A two-year phase-in period will be provided to ensure businesses have time to meet these requirements.
Authorisation holders will need to be established in UK
Under the EU BPR, authorisation holders must be established in the EU (including NI), the EEA or Switzerland.
In the national regime, authorisation holders will need to be established in the UK. To enable businesses to make the necessary arrangements, a one-year phase-in period will be provided for existing authorisation holders (to be established in the UK by 1st January 2022).
These arrangements will ensure minimal changes after the transition period ends from the current system, and that the transition will be as smooth for businesses as possible.
Other News
Significant Changes and Amendments to the IATA 62nd Edition (2021)
IATA has now published the next edition of the Dangerous Goods Regulations for air and also released the list of the significant changes and amendments due to come into force from 1 January 2021.
The 62nd edition of the IATA Dangerous Goods Regulations incorporates all amendments made by the ICAO Dangerous Goods Panel in developing the content of the 2021–2022 edition of the ICAO Technical Instructions as well as changes adopted by the IATA Dangerous Goods Board.
The list is available for download from here and includes:
1—Applicability
1.2.7—Exceptions. The list of exceptions has been revised to include dangerous goods required for the preservation of organs intended for transplant and dangerous goods dropped for pest management activities.
1.5—Training Requirements. Subsection 1.5 as shown in Appendix I in the 61st edition has been adopted to implement a competency-based approach to dangerous goods training and assessment. Subsection 1.5 from the 61st edition has been moved to Attachment A of Appendix H as there is a 2-year transition period until 31 December 2022, during which time the training provisions from the 61st edition may continue to be used.
1.7—Dangerous Goods Security. New entries have been added to the indicative list of high consequence dangerous goods shown in Table 1.7.A.
2—Limitations
2.3—Dangerous Goods Carried by Passengers or Crew
2.3.2.2—The provisions for mobility aids powered by nickel-metal hydride or dry batteries have been revised to permit a passenger to carry up to two spare batteries to power the mobility aid.
2.3.4.2—The allowance for a passenger to carry a self-inflating safety device, such as a life-jacket or vest, has been revised to permit up to two personal safety devices per person and not more than two spare gas cartridges per device.
2.3.5.8—The provisions for portable electronic devices (PED) and spare batteries for PED have been revised to amalgamate the provisions for electronic cigarettes and for PED powered by wet non-spillable batteries into
2.3.5.8. Clarification has been added to identify that the provisions also apply to dry batteries and nickel-metal hydride batteries, not just lithium batteries.
2.4—Transport of Dangerous Goods by Post
2.4.2(a)—Has been revised to identify that where dry ice is used as a refrigerant for UN 3373, all applicable parts of PI 954 must be met and the DPO must offer the mail article to the operator separately from other mail to allow the operator to comply with the applicable requirements for acceptance and information to the pilot-in-command.
3—Classification
3.6.2.5—Addition of new criteria to address solid medical waste containing Category A infectious substances.
3.8.3—Revisions to the criteria for assignment of packing groups to corrosive substances and mixtures.
4—Identification
4.2—List of Dangerous Goods
The amendments to the List of Dangerous Goods include:
● addition of three new UN numbers, UN 0511, UN 0512 and UN 0513 for Detonators, electronic in Divisions 1.1B, 1.4B and 1.4S respectively;
● addition of a new proper shipping name, Dangerous goods in articles to UN 3363;
● addition of a new UN number, UN 3549 for Medical waste, Category A, affecting animals and Medical waste, Category A, affecting humans;
● UN 2216, Fish meal, stabilized—Has been revised. Rather than being forbidden/forbidden, Fish meal, stabilized is now permitted on both passenger aircraft and Cargo Aircraft Only;
● the packing instruction number for UN 3291, Biomedical waste, n.o.s., Clinical waste, unspecified, n.o.s., Medical waste, n.o.s. and Regulated medical waste, n.o.s. has been changed from PI 622 to be PI 621;
● addition of “stabilized” to the proper shipping name for UN 2522, 2-Dimethylaminoethyl methacrylate.
4.4—Special Provisions
The amendments to the special provisions include:
● inclusion of the State of the operator, as an approving authority for lithium batteries shipped under special provisions A88 and A99. These special provisions have also been revised to identify that the packing instruction number shown on the Shipper’s Declaration must be the one identified in the special provision from the Supplement to the ICAO Technical Instructions, i.e. PI 910 for A88 and PI 974 for A99;
● replacement of “machinery or apparatus” by “article” in A107. This change reflects the addition of the new proper shipping name Dangerous goods in articles to UN 3363;
● revision to A145 to include reference to waste gas cartridges and waste receptacles, small, containing gas. The special provision now includes an allowance that waste gas cartridges and waste receptacles, small, containing gas that were filled with a Division 2.2 gas and have been pierced are not regulated;
● significant revisions to A154 to address damaged and defective lithium batteries;
● revision to A201 to allow for the transport, in the case of urgent medical need, of lithium batteries as cargo on a passenger aircraft with the approval of the State of origin and the approval of the operator.
New special provisions include:
● A215—assigned to UN 3077 and UN 3082 which permits the shipper to use a listed proper shipping name as the technical name;
● A219—assigned to UN 2216, Fish meal, stabilized specifying that antioxidants must be added to the fish meal to prevent spontaneous combustion.
5—Packing
5.0.2.5—new text has been added clarifying that packagings may meet more than one tested design type and may bear more than one UN specification mark.
Packing Instructions
PI 378 and PI 972—Have been revised to permit the fuel tanks of machinery to have up to one quarter of a tank of fuel where the machinery cannot be loaded other than upright.
The single packagings permitted in PI 457, PI 463, PI 465, PI 470, PI 471, PI 479, PI 482, PI 490, PI 491 and PI 555 have been revised to align to the packagings permitted in the UN Model Regulations and elsewhere in the DGR.
PI 492, PI 870, PI 871 and PI 872—Have been revised to clarify that the cells and/or batteries are packed directly into the outer packagings.
PI 622—Has been renumbered to become PI 621 to align to the numbering in the UN Model Regulations.
PI 650 and PI 959—Have been revised to clarify that the diamond-shaped mark with the UN number must appear on one side of the package.
PI 956—Has been revised to include reference to UN 2216, Fish meal, stabilized.
PI 957—Has been revised to allow for both combination and single packagings.
PI 962—Has been revised to include reference to the new proper shipping name Dangerous goods in articles and to use “article” or “articles” in place of “machinery or apparatus”.
PI Y963—Has been revised to identify that a unit load device prepared by a single shipper may contain dry ice as a refrigerant for the consumer commodities.
PI 965 to PI 970—Have been revised to:
● specifically reference that lithium cells or batteries identified as damaged or defective in accordance with Special Provision A154 are forbidden for transport; and
● in Section II identify that where there are packages from multiple packing instructions on one air waybill that the compliance statement may be combined into a single statement. Examples of such statements have been included in 8.2.7.
PI 967 and PI 970—Have been revised to require that:
● equipment must be secured against movement in the outer packaging; and
● multiple pieces of equipment in a package must be packed to prevent damage from contact with other equipment in the package.
6—Packaging Specifications and Performance Tests
The revisions to Section 6 include:
● clarification of the size of the UN specification marks on packagings (6.0.4.1, 6.5.3.1);
● clarification of the application of the year of manufacture for plastic drums and jerricans (6.0.4.2.1(f));
● a new provision for packagings that are tested to more than one design type (6.0.7);
● revision to the maximum capacity for metal aerosols (6.1.7.2);
● addition of a new provision identifying that for aluminium and other metal drums that suitable internal protective coatings or treatments must be applied if the materials used for the drum are not compatible with the contents to be transported (6.2.2.7, 6.2.7.7). This provision already exists for steel drums and steel and aluminium jerricans;
● revisions to the ISO references for UN cylinders and closed cryogenic receptacles (6.4.2).
7.1.4.4.1—Has been revised to clarify the height of the UN/ID number and the letters “UN” or “ID” on packages.
7.1.5.5.3—The minimum dimensions of the lithium battery mark have been revised.
8—Documentation
8.1.6.9.2, Step 7—The requirements on how to describe multiple overpacks on the Shipper’s Declaration have been revised, with an additional example provided (Figure 8.1.Q).
8.2.1—The statement required on the air waybill when dangerous goods are offered on a Shipper’s Declaration has been revised to align the language to the use of electronic documentation where the Shipper’s Declaration is not “attached” but rather is “associated”. There is a two year transition period during which time either wording is acceptable.
9—Handling
9.1.9—The previous text recommending that operators should include the transport of dangerous goods as part of their safety risk assessment process has been revised to make the requirement mandatory.
9.6.4—The requirement to provide a report to the State of origin has been deleted.
10—Radioactive Materials
The revisions to Section 10 include:
● identification in the scope that for the transport of radioactive materials the provisions are based on Revision 1 of IAEA Safety Standards Series No. SSR-6 (10.0.1.1);
● replacement of “radiation level” by “dose rate”;
● addition of new radionuclides for Germanium, Iridium, Nickel, Strontium and Terbium (Table 10.3.A);
● revision to the statement on the air waybill when dangerous goods are offered on a Shipper’s Declaration (10.8.8.1).
Appendix A—There are a number of changes, deletions and additions to the defined terms in the glossary.
These include:
● addition of definitions for carry-on and checked baggage;
● addition of definition for detonators, electronic;
● addition of definition for dose rate;
● deletion of “radiation level”;
● revision to the definition for self-accelerating decomposition temperature.
Appendix C—Changes to the list of currently assigned organic peroxides (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 guidance material on development and implementation of competency-based training for dangerous goods has been revised based on engagement with, and input from training providers and member airlines. In addition, Subsection 1.5 from the 61st edition has been moved to Attachment A in Appendix H.
IMDG Code & IMDG Code Supplement
The COVID-19 pandemic has meant many meetings at IMO have been postponed, including the Maritime Safety Committee, at which amendments to the IMDG Code and IMDG Code Supplement need to be approved.
In view of this, publication of the 2020 Editions of the IMDG Code (inc. Amendment 40-20) and the IMDG Code Supplement have been delayed and are not now envisaged before December 2020 (in digital format) at the earliest, with shipping of the hard copy editions expected in early 2021.
The current edition of the IMDG Code (inc. Amendment 39-18), remains valid until 31 December 2021.
For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk