Q.01

When must suppliers provide a safety data sheet in Ireland?

In Ireland the duty comes straight from EU REACH Article 31, which applies directly. A supplier shall provide a safety data sheet (SDS) compiled to Annex II whenever a substance or mixture meets the CLP criteria for classification as hazardous, a substance is PBT or vPvB under Annex XIII, or a substance is on the Candidate List of SVHCs [1]. The SDS must be supplied free of charge, on paper or electronically, no later than the date the substance or mixture is first supplied [2].

Approach: I read the current consolidated text of REACH (Regulation (EC) No 1907/2006), the Health and Safety Authority's (HSA) guidance as Ireland's REACH/CLP competent authority, and the Irish Chemical Agents Regulations (S.I. No. 619/2001).

When an SDS is required (REACH Art. 31)

SituationDuty
Hazardous under CLP; PBT or vPvB; on the Candidate ListShall provide, without being asked (Art. 31(1)) [1]
Mixture not classified as hazardous but containing any of the following (Art. 31(3)) [1]:Shall provide at the recipient's request
• a health- or environmental-hazard substance at ≥ 1% by weight (non-gaseous mixtures) or ≥ 0.2% by volume (gaseous mixtures)
• at ≥ 0.1% by weight (non-gaseous mixtures): a Carc. 2, Repr. 1A/1B/2, Skin Sens. 1 or Resp. Sens. 1 substance, a substance with effects on or via lactation, a PBT/vPvB, or a Candidate List substance
• a substance with an EU workplace exposure limit
Hazardous products sold to the general public with enough information for users to protect health, safety and the environmentNeed not be supplied, unless a downstream user or distributor asks for one (Art. 31(4)) [1]

If none of these applies, Article 32 still requires the supplier to pass on certain information: registration numbers, any authorisation or restriction, and other information needed for risk management. It must be sent at the latest with the first delivery and kept up to date [3].

Updates (Art. 31(9))

  • Suppliers shall update the SDS "without delay" when:
    • new information that may affect risk management measures, or new hazard information, becomes available;
    • an authorisation is granted or refused;
    • a restriction is imposed.
  • The revised SDS, dated "Revision: (date)", must go free of charge to everyone supplied in the preceding 12 months.
  • Updates after registration must include the registration number [2].

What Ireland adds (HSA guidance)

  • Language: Article 31(5) requires an official language of the Member State where the product is placed on the market, unless that state provides otherwise [1]. HSA says the SDS "must be in the language of the Member State" [4].
  • Who is responsible: the first supplier onto the EU market (the manufacturer, importer or only representative) prepares the SDS. Actors further down the chain "should also provide" one, each supplier is responsible for its contents, and a competent person must prepare it.
  • Supplier details (section 1.3): a supplier must add its own EU contact details even if it passes on its supplier's SDS unchanged [4].
  • Emergency number (section 1.4):
    • For hazardous mixtures within the scope of CLP Article 45 placed on the Irish market, the National Poisons Information Centre (NPIC) number must be given. An extra external number is allowed.
    • For other products, NPIC's number may be given, or another number. Any limits on that service (such as opening hours) must be stated.
    • NPIC charges an annual retainer for use of its number [4].
  • Section 8: where Ireland has a national occupational exposure limit (OELV) for a substance, it should be included [4].
  • Retailers: HSA reminds suppliers, including retailers, of the legal requirement to provide SDSs to professional users [4].

Employers using the chemicals: under the Chemical Agents Regulations, an employer's risk assessment must take into account the supplier's information, including the SDS (Reg. 4(1)(b)) [5]. Employees and safety representatives must also be given access to SDSs (Reg. 9(1)(d)) [6]. In the 2001 text, that access duty still names the older Irish dangerous substances and preparations regulations (1995 and 2000) as the source of the SDS. The supply-side duty itself now sits in REACH Article 31.

Q.02

What must each section contain?

Every SDS must use the 16 headings and numbered subheadings fixed in REACH Annex II, Part B. The only exception is Section 3, where you include subsection 3.1 (substances) or 3.2 (mixtures), whichever applies [7]. Information goes in "where applicable and available", but the SDS "shall not contain blank subsections" [8]. For Ireland, the HSA's national points from my last answer apply on top: the NPIC emergency number in 1.4 and Irish OELVs in Section 8.

Approach: I read Annex II (Parts A and B) of the current consolidated text of REACH, Regulation (EC) No 1907/2006, consolidated version 02006R1907-20260622.

General rules (Part A, before the sections)

  • Consistency: substance information shall match the registration and the chemical safety report (CSR). Where a CSR exists, the relevant exposure scenarios shall be annexed to the SDS. Each relevant section shall say which nanoforms it covers [8].
  • Author and wording: a trained "competent person" shall prepare it. The language shall be simple, clear and precise. Phrases like "harmless", "no health effects" or "safe under most conditions of use" shall not be used [8].
  • Layout:
    • The first page shall show the compilation date, or "Revision: (date)" plus which version it replaces.
    • Every page, including annexes, shall be numbered, with "page 1 of 3" or a "Continued on next page" / "End of safety data sheet" marker [8].
    • Units shall follow Directive 80/181/EEC.
    • An SDS is also required for the special cases with CLP labelling derogations (CLP Annex I, 1.3) [9].

Section-by-section content

SectionWhat it must contain
1. Identification1.1 Product identifier per CLP Art. 18(2) (substances) or 18(3)(a) (mixtures), as on the label. For registered substances, also the registration number. Distributors and downstream users may leave out the individual-registrant part if they can supply the full number to the enforcement authority within 7 days of a request [9]. If the SDS covers nanoforms, it must use the word "nanoform". If a UFI is shown on the SDS, it shall be given in this subsection. 1.2 At least a brief description of identified uses, plus uses advised against and why. 1.3 The supplier's full address and phone number, and an email address for the competent person. 1.4 Emergency number: the official advisory body's number shall be given where one exists, and any limits on availability (e.g. hours) shall be stated [10]
2. Hazards identification2.1 CLP classification, the same as in your C&L notification or registration. Non-classified mixtures shall say so clearly. If hazard statements are not written out in full, refer to Section 16 for the full text. 2.2 Label elements: pictograms (black and white allowed), signal word, H- and P-statements. 2.3 Whether the substance is PBT/vPvB, on the Candidate List for endocrine disruption, or meets the ED criteria of Reg. 2017/2100 or 2018/605. For mixtures, this applies to each such substance at ≥ 0.1% by weight. Also other non-classifying hazards, e.g. dust explosion ("May form explosible dust-air mixture if dispersed"), suffocation, freezing [11]
3. Composition3.1 Substances: the main constituent, plus classified impurities and additives that contribute to the classification. Give SCLs, M-factors and ATEs if available, and nanoform particle characteristics [12]. 3.2 Mixtures: identifier, concentration (exact % or ranges, in descending order) and classification for the substances in the next two rows [12]
Classified mixtures (3.2.1): list substances at or above the Table 1.1 limits. Examples: Acute Tox. 1-3, Carc. 1A/1B/2, Repr., Aquatic Acute 1/Chronic 1 at ≥ 0.1%; Skin/Resp. Sens. 1A at ≥ 0.01%; Acute Tox. 4, Skin/Eye, STOT at ≥ 1%. Also substances with Union workplace exposure limits, and PBT/vPvB, Candidate List and ED substances at ≥ 0.1% [13]
Non-classified mixtures (3.2.2): list health/environment-hazard substances and those with Union OELs at ≥ 1% by weight (non-gaseous) or ≥ 0.2% by volume (gaseous). Also list Skin/Resp. Sens. 1A at ≥ 0.01%, and reprotoxic or lactation-effect substances at ≥ 0.1% [13][14]
For each listed substance: classification codes, with the reason for listing if it is not classified (e.g. "substance with a Union workplace exposure limit"). Also the name, the registration number if available, and the EC number if available. CAS number and IUPAC name may be given [14]
4. First aidWritten so an untrained responder can follow it, stating whether medical attention is needed and how urgently. 4.1 Measures by route (inhalation, skin, eye, ingestion), and advice on fresh air, removing clothing and responder PPE [14][15]. 4.2 Key acute and delayed symptoms. 4.3 Medical monitoring, antidotes and contraindications where appropriate [15]
5. Firefighting5.1 Suitable and unsuitable extinguishing media. 5.2 Special hazards such as combustion products. 5.3 Protective actions and PPE for firefighters [15]
6. Accidental releaseDistinguish large and small spills where volume matters. 6.1 Precautions for non-emergency personnel, and the right protective clothing fabric for emergency responders. 6.2 Environmental precautions [15]. 6.3 Containment and clean-up methods, including what never to use. 6.4 Cross-references to Sections 8 and 13 [16]
7. Handling and storageMust be consistent with the CSR or exposure scenarios. 7.1 Safe handling, incompatibilities, limiting environmental release, and hygiene (no eating or drinking at work, hand washing). 7.2 Storage conditions consistent with Section 9: explosive atmospheres, ignition sources, temperature, humidity, stabilisers, ventilation, quantity limits, packaging compatibility [16]. 7.3 Specific end-use recommendations, which may refer to an attached exposure scenario or to sector guidance [17]
8. Exposure controls / PPE8.1 National OELs and biological limit values in force in the Member State where the SDS is supplied, each with its legal basis. Also monitoring procedures, limits for air contaminants formed in use, DNELs and PNECs where available, and control-banding details [17]. 8.2 Engineering controls, and detailed PPE specifications under Reg. 2016/425 and CEN standards: eye/face protection; gloves with material, thickness and breakthrough time; other skin protection; respiratory protection with filter type; thermal hazards. Also environmental exposure controls. For isolated intermediates, a statement that the SDS is consistent with the Art. 17/18 strictly controlled conditions [18]
9. Physical and chemical properties9.1 Every SDS shall cover (a)-(r): physical state, colour, odour, melting/freezing point, boiling point, flammability, explosion limits, flash point, auto-ignition and decomposition temperature, pH, kinematic viscosity (mm²/s), solubility, log Kow, vapour pressure, density, relative vapour density and particle characteristics. If a property does not apply or is unavailable, say so and give reasons where possible [19][20][21]. 9.2 Other parameters where relevant to safe use. The physical-hazard data in 9.2.1 (explosives, flammable gases and so on) are listed as "may be provided" [21][22][23]
10. Stability and reactivity10.1 Reactivity. 10.2 Chemical stability, including stabilisers; for desensitised explosives, shelf life. 10.3 Hazardous reactions. 10.4 Conditions to avoid. 10.5 Incompatible materials [23]. 10.6 Hazardous decomposition products; combustion products belong in Section 5 [24]
11. Toxicological information11.1 All ten CLP health hazard classes "shall always be listed". Where a class is not classified, state why: lack of data, technical impossibility, inconclusive data, or "based on available data, the classification criteria are not met". Registered substances also need Annex VII-XI study summaries and the CMR 1A/1B comparison. Also cover routes of exposure, symptoms, delayed and chronic effects, and whether data are human, animal or in vitro [24][25]. 11.2 Endocrine-disrupting effects for substances flagged in 2.3, and other adverse health effects [25]
12. Ecological informationGive species, media, units, duration and test conditions; experimental data take precedence over models. 12.1 Aquatic and terrestrial toxicity, and impact on sewage treatment plants. 12.2 Persistence and degradability [26]. 12.3 Bioaccumulation (Kow, BCF). 12.4 Mobility in soil. 12.5 PBT/vPvB results where a CSR is required. 12.6 Endocrine-disrupting effects on the environment. 12.7 Other effects, such as ozone depletion or global warming potential [27]
13. Disposal13.1 Waste treatment methods for the product and contaminated packaging, properties affecting treatment, discouraging sewage disposal, and special precautions, consistent with Directive 2008/98/EC [27]. Relevant Union waste provisions, or national ones in their absence, shall be referred to [28]
14. TransportClassification under ADR, RID, ADN, the IMDG Code and ICAO TI; if not available or relevant, say so. 14.1 UN/ID number. 14.2 Proper shipping name. 14.3 Transport hazard class. 14.4 Packing group. 14.5 Environmental hazard and marine pollutant status. 14.6 Special precautions for the user [28]. 14.7 Bulk carriage under IMO instruments (IBC, IMSBC, IGC), only where the cargo is intended to be carried in bulk [29]
15. Regulatory information15.1 Relevant Union and national provisions, e.g. ozone-depleting substances, POPs, PIC and Seveso. Any REACH authorisation (Title VII) or restriction (Title VIII) shall be mentioned, together with any downstream-user conditions or monitoring arrangements set by an authorisation. 15.2 Whether the supplier carried out a chemical safety assessment [29]
16. Other informationWhere changes were made in a revision, key to abbreviations, key literature and data sources, the Art. 9 CLP evaluation method used for a mixture, the full text of H- and P-statements not written out in Sections 2-15, and advice on worker training [29][7]

Irish additions (HSA guidance)

  • 1.3: add your own EU contact details even if you pass on your supplier's SDS unchanged.
  • 1.4: give the NPIC number for hazardous mixtures within CLP Article 45.
  • Section 8: include the Irish OELV where one exists [4].
Q.03