SDS Section 8: Exposure Controls and PPE Explained

Structure of Section 8

Annex II of REACH, as amended by Regulation (EU) 2020/878, prescribes the subsections of Section 8. In the US the corresponding list is in Appendix D to 29 CFR 1910.1200, which is much shorter. The table summarises the EU structure; check the wording against the Official Journal text for your own sheet.

8.1 Control parameters

Occupational exposure limits (OELs). An OEL is the upper limit of the airborne concentration of a substance in the breathing zone of a worker over a stated reference period, usually an eight-hour time-weighted average, sometimes with a short-term value. Annex II asks for the national limit values that apply, with the legal basis, for each component named in Section 3. The limits are therefore a property of the market, not of the substance: the same substance can carry different values in different Member States, in Great Britain and in the US.

Biological limit values. Where a limit applies to a biomarker in blood, urine or breath instead of, or in addition to, an air concentration, it is listed in 8.1 together with the monitoring procedure.

DNELs and PNECs. These are REACH values from the registration dossier, not workplace limits. A DNEL (derived no-effect level) is the exposure level for humans above which a substance should not be used, and a PNEC (predicted no-effect concentration) is the corresponding threshold for an environmental compartment. They belong in 8.1.4 whenever they are available, with a reference to the exposure scenario they relate to. A DNEL must not be shown as if it were a legally binding OEL.

EU limit values and national limits

EU occupational exposure limits come from two directives, and both rely on national implementation.

• Directive 98/24/EC (chemical agents at work) provides for indicative and binding occupational exposure limit values and binding biological limit values. For an indicative value (IOELV), each Member State sets a national limit that takes the EU value into account; for a binding value the national limit may not exceed the EU value. IOELVs are adopted in lists by Commission directives, for example 2017/164 (fourth list) and 2019/1831 (fifth list).
• Directive 2004/37/EC (carcinogens, mutagens and reprotoxic substances at work) sets binding limit values for listed agents in its Annex III. Exposure must not exceed them, and the employer must substitute where possible, use a closed system where substitution is not possible, and otherwise reduce exposure to a minimum.

The consequence for the SDS author is practical: an EU-level value is not automatically the figure to print. Section 8 should name the limit actually in force in the country of use, and say which. In Great Britain the equivalent is the workplace exposure limit under COSHH, which UK REACH Annex II names expressly. How the sheet differs by market is covered in SDS requirements in the EU, UK and US compared.

8.2 Exposure controls

Engineering controls come first. Annex II asks for enough detail on the controls for the identified uses for an employer to assess the risk to workers. The prevention hierarchy of Directive 98/24/EC puts substitution and technical measures ahead of protective equipment, and Section 8 should reflect that order. PPE is the last line of defence.

Personal protective equipment. The specification should refer to the relevant CEN standards and to Regulation (EU) 2016/425 on PPE:

• Eye and face: the type, for example safety glasses, goggles or a face shield, chosen according to the hazard and the potential for contact.
• Skin, hands: the glove material, its thickness and the breakthrough time, for the intended duration and type of contact. A glove tested against one chemical says little about a mixture; where no test data exist for the mixture, say so rather than naming a generic material.
• Skin, other: aprons, boots, suits and any hygiene measures.
• Respiratory: for gases, vapours, mists or dusts, the type of equipment, such as a filtering device with the appropriate filter or a breathing apparatus.
• Thermal hazards: special attention to PPE construction where the product itself is hot or cold, for example cryogenic liquids or hot melts.

Environmental exposure controls (8.2.3). This covers what the employer needs to know to meet environmental protection duties, such as containment of releases and treatment of exhaust air. It should agree with Sections 6, 12 and 13.

The US counterpart

Appendix D to 29 CFR 1910.1200 requires Section 8 to give, for the ingredients listed in Section 3, the OSHA permissible exposure limits (PELs), the ACGIH threshold limit values (TLVs) and any other limit used or recommended by the preparer, where available. It also requires appropriate engineering controls and individual protection measures such as PPE. Three different bodies are involved:

A US sheet that lists only an EU value, or an EU sheet that lists only a PEL, is incomplete for its market.

Who is responsible for what

The supplier writes Section 8 from the hazard assessment, the exposure scenarios where they exist and the applicable limits. The downstream user, as employer, must still carry out a workplace risk assessment: the SDS gives the starting information, not a finished assessment for every workplace. Where the actual use differs from the identified uses in the sheet, the employer cannot rely on the glove and respiratory advice as it stands.

Common mistakes

1. Exposure limits from another jurisdiction, or no statement of which country they come from.
2. Limits given only for the main component of a mixture.
3. DNEL or PNEC values given without exposure route, population or scenario.
4. Glove advice without material, thickness or breakthrough time.
5. PPE named but no engineering controls described.
6. Section 8 inconsistent with Sections 6 and 7, for example different respirator or glove recommendations.
7. Blank subsections; Annex II states that the SDS shall not contain blank subsections, so write "not available" or "not applicable" with a reason.

Frequently asked questions

Is an indicative EU limit value binding?

No. Under Directive 98/24/EC an indicative occupational exposure limit value must be taken into account when each Member State sets its national limit. Binding values under Directive 98/24/EC and Directive 2004/37/EC must be reflected in national law, and national binding limits may not exceed them.

Is a DNEL the same as an occupational exposure limit?

No. A DNEL is a REACH value derived from the registration data for a given route, population and exposure scenario. An OEL is a legally set workplace limit. Section 8.1 lists both under separate headings.

Does the OSHA PEL have to appear on a European SDS?

No. Section 8 of a sheet for the EU lists the limits of the Member States where the product is supplied. A US PEL belongs on the sheet supplied to the US market.

Where do exposure scenarios fit in?

If an exposure scenario is attached to the SDS and contains the information required in 8.2, the exposure controls may be given there instead. See also the duties summarised in REACH Article 31 SDS obligations. The other fifteen sections are covered in the 16 SDS sections explained.

This article is general guidance; it is not legal advice and does not replace an assessment by a competent person. Limit values change; always check the current national list.

Sources

• REACH Annex II as amended by Commission Regulation (EU) 2020/878 — CELEX:32020R0878.
• UK REACH Annex II (GB text), Section 8 — legislation.gov.uk.
• Council Directive 98/24/EC on chemical agents at work — CELEX:31998L0024; summary at EU-OSHA.
• Directive 2004/37/EC on carcinogens, mutagens and reprotoxic substances at work — CELEX:32004L0037.
• Commission Directives (EU) 2017/164 and 2019/1831 (IOELV lists) — CELEX:32017L0164, CELEX:32019L1831.
• Regulation (EU) 2016/425 on personal protective equipment — CELEX:32016R0425.
• 29 CFR 1910.1200, Appendix D, Section 8 — osha.gov; 29 CFR 1910.1000 — osha.gov.
• NIOSH Pocket Guide, introduction (REL, PEL, TWA, STEL, ceiling) — cdc.gov.