Role Finder Tool

Do you know your chemical legislation roles and duties?

The below questions are designed to assist you in understanding your roles and duties under the REACH, CLP, Detergents and PIC Regulations. Please note, that your role may vary depending on where you source each substance, mixture and article.

Irish companies dealing with the UK’s withdrawal from the EU will need to re-evaluate their roles and duties under these Regulations, particularly if they export or import chemical substances or mixtures to or from Great Britain.

Many of the duties under REACH and CLP are substance-dependent, such as registration, authorisation and notification to the classification and labelling inventory. It is important to consider that you may have more than one role depending on where you are in your supply chain and what you do with each substance, mixture or article.

Do you manufacture chemical substances?

A manufacturer is considered to be any company manufacturing a chemical substance within the EU

Do you manufacture one tonne or more per year?

Manufacturers of chemical substances, which come under the scope of REACH, who manufacture in quantities of one tonne or more per year, must register such substances with the European Chemicals Agency in accordance with the REACH Regulation (EC) No. 1907/2006. Manufacturers of substances at less than one tonne per year are not subject to REACH registration.

Do you place the substance on the market?

Manufacturers of substances must determine whether hazard classification applies to a substance based on the criteria set out in the CLP Regulation. Where classification is required, manufacturers must classify, label and package in accordance with the CLP Regulation (EC) No. 1272/2008.

Manufacturers must notify the classification and labelling details to the classification and labelling inventory, regardless of tonnage.

If the substance is classified in any hazard class (physical, health or environment) in accordance with CLP and/or is included on the candidate list the manufacturer is responsible for compiling and providing the safety data sheet. If a safety data sheet is not required, the recipient should still receive information on registration, authorisation, restriction and risk management measures.

Have you checked whether the substance is subject to Authorisation?

Manufacturers of substances included on Annex XIV (Authorisation List) may only place the substance on the market after the substance’s ‘sunset date’ if an Authorisation has been granted by ECHA.

Have you checked whether the substance is subject to Restriction?

The manufacture of certain substances is restricted under REACH and manufacturers must comply with the specific conditions of the restriction text listed on Annex XVII (Restriction List).

Do you produce articles?

An article is an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition. This would include jewellery, clothing and furniture for example. The producer of an article makes or assembles the article in the EU including Norway, Iceland, Liechtenstein and Northern Ireland but excluding Great Britain.

Have you determined whether you need to Register any substance(s) in any article you produce?

Producers must register substances in articles with the European Chemicals Agency if the substance is present in all produced articles in quantities of one tonne or more per year and the substance is intended to be released under normal or reasonably foreseeable conditions of use.

Do you need to notify any substances of very high concern contained in any article you produce?

Article producers must notify substances listed on the candidate list to ECHA if they are present in all produced articles in quantities of one tonne or more per year and the substance is present in each article at 0.1% w/w or more.

If articles containing 0.1% w/w or more of a substance on the candidate list are placed on the market, sufficient information must be provided to enable safe use of the article, including as a minimum the name of the substance.

Have you determined whether any of the substance(s) in any article you produce is Restricted?

Articles containing substances listed on Annex XVII (Restriction List) may only be placed on the market if they comply with the specific conditions of the restriction.

Do you import any chemical substance or mixture from outside the EU (incl. Great Britain)?

An importer is any EU-based company/legal person that imports a chemical substance or mixture from outside the EU, including imports from Great Britain.

Do you import more than one tonne per year of the substance collectively across imported substances and mixtures?

Importers of chemical substances on their own and in mixtures from outside the EU in quantities of one tonne or more per year, must register such substances with the European Chemicals Agency in accordance with REACH. Importers of a substance below the one tonne threshold do not require REACH registration.

Have you checked whether classification applies to the imported chemicals?

Regardless of tonnage, import is considered as ‘placing on the market’ therefore importers must determine whether classification applies based on the criteria set out in the CLP Regulation. Where classification is required, importers must classify, label and package in accordance with the CLP Regulation and notify to the classification and labelling inventory at ECHA.

Have you determined whether a safety data sheet is required?

If the substance or mixture is classified in any hazard class (physical, health or environment) in accordance with CLP and/or is included on the candidate list the importer must compile and provide a safety data sheet. If the mixture contains ≥ 1% (0.2% for gaseous) of a substance posing a health or environmental hazard, or ≥ 0.1% of a CMR, PBT or vPvB substance or contains a substance that has an occupational exposure limit value, the safety data sheet should be available on request.

If a safety data sheet is not required, the recipient should still receive information on registration, authorisation, restriction and risk management measures.

Have you determined whether notification to the National Poison Centre is required?

Importers of hazardous (health and/or physical endpoint classifications) mixtures placed on the Irish market must notify the National Poison Information Centre (NPIC) and include their emergency telephone number in Section 1.4 of the safety data sheet.

Please note that all EU poison centres will be harmonised and information for professional and consumer uses can be submitted to the Poison Centre Notification (PCN) portal from 1st January 2021, which will include the generation of a Unique Formula Identifier (UFI) for inclusion on the label and safety data sheet. Industrial uses must be notified to the PCN portal from 1st January 2024 and until that time should be submitted as normal to NPIC. If you have notified to the National Poison Centre before 1st January 2021 you may benefit from a transitional period before notifying to the PCN until 1st January 2025.

Have you checked whether the substance is subject to Authorisation?

Substances listed on Annex XIV (Authorisation List) may only be imported after the substance’s ‘sunset date’ if an Authorisation has been granted by ECHA.

Have you checked whether the substance is subject to Restriction?

Certain substances listed on Annex XVII (Restriction List) may be restricted from import or ‘placing on the market’.

Have you checked whether the substance is subject to the PIC Regulation?

Importers of substances on their own or in mixtures from outside the EU, that are listed on Annex I of the PIC Regulation (EC) No.649/2012 must submit annual tonnage information by 31st March of the following year. You can check whether your substance is listed by checking on ECHAs website and reading further information here.

Is the product you are importing a detergent?

Detergents must comply with the additional, specific labelling and packaging requirements outlined in the Detergents Regulation (EC) No. 648/2004 and on our website.

 

Do you import articles from outside the EU?

An article is an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition. This would include jewellery, clothing and furniture for example. Companies importing articles from outside the EU, including Great Britain are considered article importers under chemical legislation.

Have you determined whether you need to Register any substance(s) in any article you import?

Importers must register substances in articles with the European Chemicals Agency if the substance is present in all imported articles in quantities of one tonne or more per year and the substance is intended to be released under normal or reasonably foreseeable conditions of use.

Do you need to notify any substances of very high concern contained in any article you import?

Importers of articles must notify substances listed on the candidate list to ECHA if they are present in all imported articles in quantities of one tonne or more per year and the substance is present in each article at 0.1% w/w or more.

If articles containing 0.1% w/w or more of a substance on the candidate list is placed on the market, sufficient information must be provided to enable safe use of the article, including as a minimum the name of the substance.

Have you determined whether any of the substance(s) in any article you import is Restricted?

Articles containing substances listed on Annex XVII (Restriction List) may only be imported or placed on the market if they comply with the specific conditions of the restriction.

Do you bring in chemicals from within the EU for formulation?

Companies who source substances or mixtures from within the EU (including Iceland, Norway, Liechtenstein and Northern Ireland) for the purposes of formulation are not considered as importers under chemical legislation, but are considered ‘downstream users’.

Have you checked whether classification applies to the final formulated mixture?

Downstream users who formulate mixtures must determine whether classification applies to the final mixture based on the criteria set out in the CLP Regulation. Where classification applies, the formulator is responsible for classifying, labelling and packaging in accordance with CLP. If the mixture is classified under certain hazard classes and sold to the general public, the formulator must ensure the packaging includes a tactile warning of danger and/or a child-resistant fastening.

For hazardous mixtures placed on the market, do you need to provide a safety data sheet?

If the mixture is classified in any hazard class (physical, health or environment) in accordance with CLP and/or is included on the candidate list the formulator is responsible for compiling and providing the safety data sheet to recipients. If the mixture contains ≥ 1% (0.2% for gaseous) of a substance posing a health or environmental hazard, or ≥ 0.1% of a CMR, PBT or vPvB substance or contains a substance that has an occupational exposure limit value, the safety data sheet should be available on request. Formulators do not need to provide safety data sheets to non-professional consumers, but must provide them to other recipients in their supply chain.

If a safety data sheet is not required, the recipient should still receive information on registration, authorisation, restriction and risk management measures.

Have you determined whether notification to the National Poison Centre is required?

Formulators of hazardous (health and/or physical endpoint classifications) mixtures placed on the Irish market must notify the National Poison Information Centre (NPIC) and include their emergency telephone number in Section 1.4 of the safety data sheet.

Please note that all EU poison centres will be harmonised and information for professional and consumer uses can be submitted to the Poison Centre Notification (PCN) portal from 1st January 2021, which will include the generation of a Unique Formula Identifier (UFI) for inclusion on the label and safety data sheet. Industrial uses must be notified to the PCN portal from 1st January 2024 and until that time should be submitted as normal to NPIC.  If you have notified to the National Poison Centre before 1st January 2021 you may benefit from a transitional period before notifying to the PCN until 1st January 2025.

Have you checked whether any substance in your mixture requires Authorisation?

Substances listed on Annex XIV (Authorisation List) may only be placed on the market after the substance’s ‘sunset date’ if an Authorisation has been granted by ECHA.

Have you checked whether any substance in your mixture is Restricted?

Formulators must be cognisant of the substances listed on Annex XVII (Restriction List) and ensure that the intended use of the product they are placing on the market complies with the specific conditions of the restriction text.

Is the product you are formulating considered a detergent?

Detergents must comply with the additional, specific labelling and packaging requirements outlined in the Detergents Regulation (EC) No. 648/2004 and on our website.

Do you re-fill chemicals that you source from within the EU?

Companies who source substances or mixtures from within the EU (including Iceland, Norway, Liechtenstein and Northern Ireland) to re-fill are not considered as importers under chemical legislation, but are considered ‘downstream users’. Downstream users who re-fill hazardous substances or mixtures and thereby re-package with their own label must ensure that the correct hazard information is included on the label and that the package is sufficient for the hazard it poses (tactile warnings of danger and child-resistant fastenings) before placing it on the market. The hazard information on the label must mirror the information in Section 2.2 of the safety data sheet and the safety data sheet must be supplied to professional users and made available to employees.

 

Have you determined whether notification to the National Poison Centre is required?

Re-fillers and re-labellers of hazardous mixtures (health and/or physical endpoint classifications), must notify the National Poison Information Centre (NPIC) as a ‘downstream user’, unless their supplier has notified on their behalf. Once the mixture is notified, the NPIC emergency telephone number in Section 1.4 must be included in the mixture’s safety data sheet.

Please note that all EU poison centres will be harmonised and information for professional and consumer uses can be submitted to the Poison Centre Notification (PCN) portal from 1st January 2021, which will include the generation of a Unique Formula Identifier (UFI) for inclusion on the label and safety data sheet. Industrial uses must be notified to the PCN portal from 1st January 2024 and until that time should be submitted as normal to NPIC.  If you have notified to the National Poison Centre before 1st January 2021 you may benefit from a transitional period before notifying to the PCN until 1st January 2025.

Have you checked whether any substance in your mixture requires Authorisation?

Substances listed on Annex XIV (Authorisation List) may only be placed on the market after the substance’s ‘sunset date’ if an Authorisation has been granted by ECHA.

Have you checked whether any substance or substance in your mixture you re-fill is restricted?

Re-fillers and re-labellers  must also be aware of the substances listed on Annex XVII (Restriction List) and ensure that the intended use of the chemical that they are placing on the market complies with the specific conditions of the restriction text.

Is the product you are re-packaging and/or re-labelling considered a detergent?

Detergents must comply with the additional, specific labelling and packaging requirements outlined in the Detergents Regulation (EC) No. 648/2004 and on our website.

Do you distribute chemicals that you source from within the EU?

Companies who source substances or mixtures from within the EU (including Iceland, Norway, Liechtenstein and Northern Ireland) are not considered as importers under chemical legislation, but are considered ‘distributors’.

 

Have you checked the hazard labelling and the packaging of the chemicals?

Distributors that only sell or distribute hazardous substances or mixtures must ensure that they are labelled and packaged in accordance with CLP, including ensuring that EU-based supplier details are on the label.

Have you ensured that any relevant safety data sheets have been provided to your customers?

Safety data sheets must be provided to all customers including professional users upon first delivery and following any updates. The safety data sheet must be up-to-date, in the correct 16 heading format and in the English language for the Irish market.

Do you use chemicals that you source from within the EU?

Companies who source substances or mixtures from within the EU (including Iceland, Norway, Liechtenstein and Northern Ireland) are not considered as importers under chemical legislation, but are considered ‘end users’.

End users who use hazardous substances or mixtures in a professional capacity must read the product label and maintain an up-to-date version of the safety data sheet which can be accessed by workers and those exposed to the product. End users must ensure that they apply the precautionary measures specific to their use as outlined in the safety data sheet communicated to them.

Users of substances listed on Annex XVII (Restriction List) must ensure that their use complies with the specific conditions of the restriction text. More information on the obligations of downstream users is available here.

Do you export chemicals outside the EU?

Companies that export chemicals to countries outside of the EU, including to Great Britain but not Northern Ireland, are considered ‘exporters’ under chemical legislation. Exporters must check to see if the chemical substance, on its own or in a mixture, is listed in the PIC Regulation.

Substances on their own or in mixtures listed in Annex I of the PIC Regulation must be notified at least 35 days prior to intended export using the ePIC IT tool, regardless of tonnage. Substances listed in Annex V to the PIC Regulation are banned for export outside of the EU.

The export of PIC chemicals on their own or contained in a hazardous mixture, must be classified labelled and packaged in accordance with CLP and be accompanied by a safety data sheet in English and in one of the official languages of the importing country (if different).

Exporters must also submit annual tonnage information by 31st March of the year following export. More information is available here

Do you supply chemicals to another country within the EU?

Companies supplying chemical substances or mixtures to other countries within the EU, including Norway, Iceland, Liechtenstein and Northern Ireland are not considered as ‘exporters’ under chemical legislation.

 

Is the substance or mixture hazarous?

Companies supplying substances or mixtures onto the EU market (domestic or otherwise) must ensure the product is classified, labelled and packaged in accordance with CLP. This includes providing hazard information in the language of the country in which the product is being placed on the market.

Have you determined whether a safety data sheet is required?

If the substance or mixture is classified in any hazard class (physical, health or environment) in accordance with CLP and/or is included on the candidate list a safety data sheet must be provided in the language of the country in which it is placed on the market. If the mixture contains ≥ 1% (0.2% for gaseous) of a substance posing a health or environmental hazard, or ≥ 0.1% of a CMR, PBT or vPvB substance or contains a substance that has an occupational exposure limit value, the safety data sheet should be available on request.

If a safety data sheet is not required, the recipient should still receive information on registration, authorisation, restriction and risk management measures.

Have you determined whether notification to the Poison Centre in the importing country is required?

Hazardous (health and/or physical endpoint classifications) mixtures must be notified to the Poison Centre in which the product is placed on the market and their emergency telephone number included in Section 1.4 of the safety data sheet.

Please note that all EU poison centres will be harmonised and information for professional and consumer uses can be submitted to the Poison Centre Notification (PCN) portal from 1st January 2021, which will include the generation of a Unique Formula Identifier (UFI) for inclusion on the label and safety data sheet. Industrial uses must be notified to the PCN portal from 1st January 2024 and until that time should be submitted as normal to the poison centre in the importing country. If you have notified the poison centre in the country in which the product is placed on the market before 1st January 2021, you may benefit from a transitional period before notifying to the PCN until 1st January 2025.