Q&As
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The UKs withdrawal from the EU
Northern Ireland Protocol
What does the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) mean from the REACH perspective?
The IE/NI Protocol provides that REACH applies to and in the United Kingdom in respect of Northern Ireland. REACH does not apply in other parts of the United Kingdom (‘Great Britain’).
On a practical level this means that:
- substances manufactured in or imported to Northern Ireland need to be registered with ECHA, including substances imported from Great Britain to Northern Ireland;
- substances shipped from Northern Ireland to the EU/EEA are not considered ‘imported’ from the registration perspective;
- an Only Representative based in Northern Ireland is considered equal to an Only Representative in the EU/EEA;
- a manufacturer, formulator or an article producer in Northern Ireland cannot appoint an only representative;
- authorisation obligations apply to Annex XIV substances placed on the market for a use or used in Northern Ireland, including substances imported from Great Britain to Northern Ireland.
The IE/NI Protocol will start to apply as of 1 January 2021.
What does the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) mean from the CLP perspective?
The IE/NI Protocol provides that CLP applies to and in the United Kingdom in respect of Northern Ireland. CLP does not apply in other parts of the United Kingdom (‘Great Britain’).
On a practical level this means that:
- substances and mixtures placed on the market in Northern Ireland must be classified, labelled and packaged according to the CLP Regulation;
- such classification and labelling elements must be notified to the C&L Inventory;
- companies located in Northern Ireland need to follow the scientific and technical developments in relation to the substances and mixtures they place on the market, and update classification and labelling accordingly;
- if a company in Northern Ireland holds information leading to a change in harmonised classification, they need to submit a change proposal to the Competent Authority in one of the EU Member States in which the substance is placed on the market. The UK(NI) Authority cannot act in this role, so the company needs to contact a Competent Authority in an EU Member State.
- importers and downstream users placing mixtures on the market in Northern Ireland must provide information on emergency health response to the UK/NI Appointed body and include a UFI on the label. EU/EEA companies placing on the market hazardous mixtures supplied by companies established in NI, without performing any activity qualifying as use, will remain distributors with no direct notification obligations under Article 45. However, distributors (e.g. re-branders) must make sure to only place CLP compliant products on the market and ensure that all product identifiers (in particular trade/brand names) and UFIs under which the mixture is placed on the market are covered by a submission to the relevant appointed body in the EU/EEA (Activities leading to submission obligations according to Article 4(10)). For more information on roles and responsibilities according to the specific activity please see the Guidance on Annex VIII.
Will the obligations to notify hazardous mixtures according to Article 45 and Annex VIII of CLP (poison centres notifications) apply to downstream users and importers based in Northern Ireland?
Yes, if they intend to place those mixtures on the EU/EEA market, or Northern Ireland. CLP applies to and in the United Kingdom in respect of Northern Ireland.
Companies established in Northern Ireland will be able to use the ECHA Submission portal to notify mixtures to be placed on the EU/EEA market. However, when placing mixtures on the Northern Ireland market the UK national system will have to be used instead.
CLP does not apply in other parts of the United Kingdom (‘Great Britain’). Therefore, the obligations under Article 45 and Annex VIII will not apply to companies based in Northern Ireland if they intend to place a hazardous mixture on the market of Great Britain.
Does a biocidal product made available on the market and/or used in Northern Ireland after the end of the transitional period have to comply with the BPR?
Yes, the IE/NI Protocol provides that the BPR will apply to and in the United Kingdom in respect to Northern Ireland after the transitional period ends. Biocidal products shall not be made available on the market of Northern Ireland or used unless authorised in accordance with the BPR after the transitional period.
Is a biocidal product or treated article manufactured in Northern Ireland and shipped to the EU/EEA after the end of the transitional period considered an imported biocidal product or treated article in the EU/EEA?
No, shipments of treated articles or biocidal products authorised in accordance with the BPR from Northern Ireland to the EU/EEA will not be considered as imports to the EU/EEA.
Is a biocidal product or treated article shipped from Great Britain to Northern Ireland, after the end of the transitional period considered an imported biocidal product?
Yes, biocidal products or treated articles shipped from the UK (Great Britain) into Northern Ireland will be considered as being placed on the EU/EEA market. The company in Northern Ireland receiving the shipment would therefore be considered as the importer of the biocidal product or treated articles into the EU/EEA.
Can a biocidal product authorisation holder as defined in Article 3(2)(p) of the BPR be based in Northern Ireland?
Yes, it will be possible for an authorisation holder as defined in Article 3(2)(p) of the BPR to be established in Northern Ireland after the end of the transitional period.
Can the United Kingdom in respect to Northern Ireland act as evaluating Competent Authority or receiving Competent Authority in the context of the approval of active substances or authorisation of biocidal products after the end of the transitional period?
It will not be possible for the United Kingdom, in respect to Northern Ireland, to act as evaluating Competent Authority for active substance approval application or Union authorisation applications after the end of the transitional period. The United Kingdom, in respect to Northern Ireland can act as the receiving Competent Authority for applications for national authorisations of biocidal products (Article 29 BPR) and as the evaluating Competent Authority for simplified authorisations of biocidal products (Article 26 BPR) for the territory of Northern Ireland.
After the end of the transitional period, can my company based in Northern Ireland and holder of a product authorisation under the BPR for Northern Ireland apply for the mutual recognition of that biocidal product authorisation in accordance with Articles 33 and 34 of the BPR in an EU/EEA country?
No, it will not be possible to apply for mutual recognition of a biocidal product authorisation in accordance with Articles 33 and 34 of the BPR when the reference authorisation has been granted /by the UK authority in respect to Northern Ireland applicable for Northern Ireland.
As a supplier of a biocidal product I would like to apply for national authorisation in (Article 29 BPR) or simplified authorisation (Article 26 BPR) in Northern Ireland. How should I submit my application?
It will not be possible to submit such an application via R4BP 3. For applications for national authorisations of biocidal products (Article 29 BPR), for simplified authorisations (Article 26 BPR) of the BPR and applications in accordance with Chapter VIII (mutual recognition procedures) of the BPR, the UK(NI) companies need to apply through the national system of UK to make their applications.
We suggest the applicant to contact the UK authority in respect to Northern Ireland to obtain further information on how to practically proceed with the submission.
I am based in Northern Ireland and would like to apply for the approval of an active substance and/or technical equivalence, am I eligible to do so?
Yes, it will be possible to apply for active substance approval and technical equivalence using R4BP3. However, the United Kingdom, in respect to Northern Ireland, cannot act as the evaluating Competent Authority for the active substance approval application.
What does the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) mean from the PIC perspective?
The IE/NI Protocol provides that the PIC Regulation applies to and in the United Kingdom in respect of Northern Ireland. The PIC Regulation does not apply in other parts of the United Kingdom (‘Great Britain’).
This means that:
- shipments of chemicals between Northern Ireland and the EU are not considered as imports or exports, and therefore the PIC Regulation does not apply to such shipments;
- shipments of chemicals between Northern Ireland and third countries – including Great Britain after the end of the transition period - are considered as imports or exports and therefore the PIC Regulation applies to such shipments.
In practice, the main obligations for importers or exporters of PIC chemicals based in Northern Ireland are:
- to notify upon the first export of the calendar year for each substance listed in Annex I to the PIC Regulation and each importing country;
- to report during the first quarter of each year, the quantity of each Annex I PIC chemicals exported from, or imported to the EU in the preceding year;
- to package and label the chemicals that are intended for export in accordance with the related provisions established in the CLP, BPR and REACH; in particular, a Safety Data Sheet (SDS) in accordance with the REACH Regulation shall accompany chemicals when exported;
- not to export chemicals and articles as listed in Annex V to the PIC Regulation.
However, according to Article 6(1) of the IE/NI Protocol, provisions of Union law made applicable by the Protocol which prohibit or restrict the exportation of goods shall only be applied to trade between Northern Ireland and other parts of the United Kingdom to the extent strictly required by any international obligations of the Union.
More specifically, this means inter alia the following:
- the export of chemicals listed in Annex I to Regulation (EU) No 649/2012 from Northern Ireland to Great Britain has to comply only with the rules of that Regulation that implement the Convention. For example, the export of a chemical listed in Part 2 of Annex I to Regulation (EU) No 649/2012 from Northern Ireland to Great Britain has to be notified by the exporter but there is no requirement to get the explicit consent of the United Kingdom in respect of Great Britain;
- the rules on packaging and labelling of chemicals only apply to exports of chemicals from Northern Ireland to Great Britain to the extent necessary to comply with Article 13 of the Convention.
Exporters of PIC chemicals based in Northern Ireland have also to submit a “Special RIN request” for the export of a chemical for the purpose of research or analysis, in quantities that are unlikely to affect human health or the environment and that in any event do not exceed 10 kg from each exporter to each importing country per calendar year.
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