REACH Requirements for Irish Companies

REACH (Regulation (EC) No 1907/2006) applies directly in Ireland, as in every EU Member State. What a company in Ireland must do depends on its role in the supply chain: manufacturer, importer, Only Representative, producer or importer of articles, distributor or downstream user. Ireland adds a national enforcement layer under the Chemicals Act 2008. A breach of REACH is a criminal offence there, and the Health and Safety Authority (HSA) is the lead competent and enforcement authority ^[1].

Approach: I read the current consolidated REACH text and the HSA's REACH guidance pages, written in its role as Ireland's national competent authority. I checked the national offences and penalties in the Law Reform Commission's revised Chemicals Act 2008, updated to 17 December 2024.

Duties by role

Manufacturers and importers of substances, on their own or in mixtures

• Registration. Anyone who manufactures or imports a substance at one tonne or more per year "shall submit a registration" to ECHA, with the fee ^[2].

• No data, no market. A substance that has to be registered cannot be manufactured or placed on the market until it is ^[3].

• The HSA's guidance on the process:

  • You submit an inquiry first, then join the joint submission for the substance.
  • Above 10 tonnes per year you also need a chemical safety report.
  • You must keep the dossier up to date.
  • For an imported mixture, each substance in it that reaches one tonne or more per year has to be registered.
  • Exemptions include medicinal products, food and feed, substances in Annexes IV and V, and polymers. PPORD (product and process orientated R&D) is also exempt, but needs a notification to ECHA.

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Producers and importers of articles

• Registration. Required when a substance is intended to be released from the article and the total exceeds one tonne per producer or importer per year ^[6].

• Notifying ECHA of SVHCs. Required when a Candidate List substance is in the articles at more than 0.1% w/w and more than one tonne per year.

  • The duty applies six months after the substance is added to the Candidate List.
  • It does not apply if exposure can be excluded or the substance is already registered for that use.

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Only Representatives

• A company outside the EEA has no REACH obligations itself. It can appoint an Only Representative established in the EEA, who takes on the importer's obligations. The importers in that supply chain are then treated as downstream users ^[5].

Downstream users (for example formulators, re-fillers and industrial or professional end users)

• Risk management. You must identify and apply the risk-management measures in the safety data sheet you receive ^[8].
• Uses outside the exposure scenario. For a use outside the exposure scenario, or one your supplier advises against, you must prepare your own chemical safety report. Exemptions include use below one tonne per year and PPORD ^[9].
• Reporting to ECHA. You must report in these cases ^[10]:
  • you have to prepare that chemical safety report;
  • you rely on the below-one-tonne or PPORD exemption;
  • your classification of a substance differs from your supplier's.
• Deadlines ^[11]:
  • Article 38 reporting: at the latest six months after receiving the registration number in the safety data sheet.
  • Article 37 duties: at the latest 12 months after receiving it.

Distributors (for example retailers and wholesalers)

• Pass safety data sheets and SVHC information down the supply chain, and pass information from customers back up to suppliers ^[5].
• If you dilute, formulate or refill a product, you are a downstream user rather than a distributor.

Duties that apply to every supplier

Safety data sheets (Article 31)

• When required. An SDS compiled in accordance with Annex II must be provided for ^[12]:

  • hazardous substances and mixtures;
  • PBT and vPvB substances;
  • Candidate List substances.

• Mixtures that are not classified. An SDS must be provided on request if the mixture contains a substance above the thresholds in Article 31(3).

• Format and updates. The SDS must be free of charge and in an official language of the Member State where the product is placed on the market. It must be updated without delay, and the update sent to everyone you supplied in the previous 12 months ^[13].

• Points the HSA highlights for SDSs on the Irish market:

  • Section 1.4 must carry the National Poisons Information Centre emergency number for hazardous mixtures within the scope of CLP Article 45.
  • Section 8 should include any Irish national occupational exposure limit value (OELV).

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Other supply-chain duties

• No SDS needed. You must still pass on registration numbers, authorisation and restriction details, and risk-management information (Article 32) ^[15].
• Articles containing SVHCs above 0.1% w/w (Article 33) ^[16]:
  • give recipients enough information for safe use, including at least the substance name;
  • give consumers the same information within 45 days if they ask.
• Workers' access. Employers must give workers and their representatives access to SDS and Article 32 information (Article 35) ^[17].
• Records (Article 36). Keep the information you need for your REACH duties for at least 10 years after you last handled the substance or mixture. You must make it available without delay if the competent authority asks ^[18].

Authorisation and restriction

• Authorisation (Annex XIV). You may not place on the market or use an Annex XIV substance after its sunset date unless one of these applies ^[19]:
  • the use is authorised;
  • the use is exempt;
  • an application is pending, having been filed at least 18 months before the sunset date;
  • a downstream user is relying on an authorisation held by someone further up its supply chain.
• What the HSA notes ^[20]:
  • Manufacturing a substance falls outside authorisation.
  • Authorisation does not apply to articles made outside the EU and imported.
• Restrictions (Annex XVII). A restricted substance, on its own, in a mixture or in an article, "shall not be manufactured, placed on the market or used" unless it meets the conditions of the restriction ^[21]. The HSA points out that this includes online sales ^[22].

Irish enforcement (Chemicals Act 2008, as revised)

REACH requires each Member State to set penalties that are "effective, proportionate and dissuasive" (Article 126) ^[23]. In Ireland, the revised Chemicals Act 2008 does this as follows:

• Section 29(3). A distributor, downstream user, importer, manufacturer, Only Representative (a person appointed under Article 8) or producer of an article that contravenes a provision of REACH applying to it "shall be guilty of an offence".
• Section 30(1) penalties:
  • on summary conviction, a fine of up to €5,000, up to 12 months' imprisonment, or both;
  • on conviction on indictment, a fine of up to €3,000,000, up to 2 years' imprisonment, or both.
• Prosecution costs. On conviction in a case brought by a national authority, the court shall normally order you to pay the authority's investigation and prosecution costs.
• Other enforcement tools in the Act:
  • inspectors;
  • improvement-plan directions, contravention notices and prohibition notices;
  • information notices (with a 7-day appeal to the District Court);
  • fixed payment notices of up to €2,000;
  • a yearly list of convicted persons, compiled and published by the HSA.

The HSA's chemicals helpdesk can be reached at chemicals@hsa.ie or 0818 289 389 ^[1].

Sources: Chemicals Act 2008, Revised (Law Reform Commission)