Q.01

How should I label hazardous chemicals in Great Britain?

In Great Britain, a hazardous substance or mixture sold in packaging needs a GB CLP label. The supplier has to classify it first, and the label must be written in English and show: the supplier's name, address and phone number; the nominal quantity (for packs sold to the general public); product identifiers; and, where they apply, hazard pictograms, a signal word, hazard statements, precautionary statements and supplemental information [1]. Every supplier is responsible for this before the product goes on the market [2].

Approach: I read the GB CLP Regulation as it applies in Great Britain (the retained Regulation (EC) No 1272/2008, latest revised text): Articles 4 and 17-35 and Annexes I and II. I did not look at individual substance entries in the GB mandatory classification and labelling list (GB MCL list) or at HSE guidance.

1. Classify first

  • Manufacturers, importers and downstream users "shall classify" before placing on the market (Article 4(1)). If a substance has an entry in the GB MCL list, you use that entry for the hazard classes it covers. You classify yourself only for hazard classes the entry does not cover (Article 4(3)) [2].
  • Distributors and downstream users based in GB may use a classification made by another actor in the supply chain. Downstream users can do this only if they do not change the composition (Article 4(5)-(6)) [2].

2. Label content (Articles 17-22)

  • Language: English. You may add other languages, but only if every language carries the same details [1].
  • Product identifier: use the same name as on the safety data sheet [3].
    • Substances: the name and identification number from the GB MCL list. If the substance isn't on the list, give the CAS number plus the IUPAC name or another international chemical name.
    • Mixtures: the trade name, plus the identity of the substances that drive the classification for acute toxicity, corrosion or serious eye damage, CMR, sensitisation, STOT or aspiration hazard. Up to four chemical names is usually enough [3].
  • Pictograms, signal word, hazard statements: take them from the Annex I tables for each classification [4][5]. If "Danger" is on the label, "Warning" must not appear [5]. For substances on the GB MCL list, use the hazard statements from the list entry [6].
  • Precautionary statements: choose them under Annex IV, taking account of the intended use [7].

3. Precedence rules (fewer, non-redundant elements)

  • Pictograms (Article 26):
    • If GHS06 applies, GHS07 shall not appear.
    • If GHS05 applies, GHS07 shall not appear for skin or eye irritation.
    • If GHS01 applies, GHS02 and GHS03 become optional.
    • If GHS02 or GHS06 applies, GHS04 becomes optional [8].
  • Hazard statements: show all of them unless there is evident duplication or redundancy [9].
  • Precautionary statements: "not more than six" unless more are needed to reflect the nature and severity of the hazards. Products for the general public need a disposal statement [10].

4. Supplemental information (Article 25, Annex II)

  • Mandatory supplemental statements must go in the supplemental section, including any given in the GB MCL list. You may add your own information if it does not obscure or contradict the core label elements [11].
  • Claims such as "non-toxic", "non-harmful", "non-polluting" or "ecological" "shall not appear" [11].
  • Annex II Part 2 sets EUH statements for particular mixtures [12][13]:
MixtureStatement
Paints and varnishes with more than 0.15 % leadEUH201
Cyanoacrylate adhesivesEUH202
Cement with more than 0.0002 % soluble Cr(VI)EUH203
IsocyanatesEUH204
Epoxy constituents with average molecular weight ≤ 700EUH205
More than 1 % active chlorineEUH206
Cadmium brazing or soldering alloysEUH207
Not classified as sensitising but containing a sensitiserEUH208
Some halogenated-hydrocarbon liquidsEUH209/209A
Unclassified mixtures not for the general public that contain listed ingredientsEUH210, "Safety data sheet available on request"
  • In the GB text, Article 25(5), (7) and (8) are shown as omitted [11].

5. Layout and size (Articles 31-32, Annex I 1.2.1)

  • The label must be firmly fixed to the packaging that immediately holds the product, and readable horizontally when the pack is set down normally. Text must be clear and indelible [14].
  • Pictograms, signal word, hazard statements and precautionary statements must be located together [15].
  • Pictograms are a square set on a point, with a black symbol on a white background and a red frame. Each must cover at least 1/15 of the label area and be at least 1 cm² [16].
  • Minimum sizes by package capacity [16]:
CapacityLabel (mm)Each pictogram (mm)
≤ 3 Lat least 52 × 74, if possiblenot smaller than 10 × 10; at least 16 × 16 if possible
> 3 L to ≤ 50 L≥ 74 × 105≥ 23 × 23
> 50 L to ≤ 500 L≥ 105 × 148≥ 32 × 32
> 500 L≥ 148 × 210≥ 46 × 46

6. Combination packs and transport labels (Article 33)

  • If the outer packaging carries dangerous-goods transport labels, the inner packaging must have the CLP label. A CLP pictogram for the same hazard as the transport label need not appear on the outer packaging.
  • A single package that falls under transport rules must carry both labels, but a duplicated pictogram for the same hazard need not appear [17].

7. Small or awkward packs and special cases

  • Packs too small or oddly shaped for a label: use fold-out labels, tie-on tags or the outer packaging. The inner packaging must still show the pictograms, the product identifier, and the supplier's name and phone number [18][19].
  • Contents not exceeding 125 ml: hazard and/or precautionary statements may be left off for the hazard categories listed in Annex I 1.5.2.1 [19].
  • Inner packs not exceeding 10 ml for R&D or QC: reduced labelling is allowed. It does not apply to plant protection products or biocides [19][20].
  • Special cases with their own rules: gas cylinders, LPG cartridges, aerosols with an aspiration hazard, massive metals, alloys and polymer mixtures, pyrotechnics, and products that are only corrosive to metals (Article 23, Annex I 1.3) [21][16][22].

8. Consumer packaging (Article 35, Annex II Part 3)

  • Packs for the general public must not look attractive to children or resemble food, feed, medicines or cosmetics [23].
  • Child-resistant fastenings are required for consumer products classified as [13]:
    • acute toxicity categories 1-3, STOT SE 1, STOT RE 1 or Skin Corr. 1;
    • an aspiration hazard (not aerosols or sealed sprays);
    • containing methanol at ≥ 3 % or dichloromethane at ≥ 1 %.
  • These fastenings must meet EN ISO 8317 (reclosable) or EN 862 (non-reclosable) [24].
  • Tactile warnings (EN ISO 11683) are required for consumer products with any of these classifications [24]:
    • acute toxicity, skin corrosion, or respiratory sensitisation;
    • category 2 mutagenicity, carcinogenicity or reproductive toxicity;
    • STOT 1 or 2, or aspiration hazard;
    • flammable gases, flammable liquids 1-2, or flammable solids.

9. Keeping labels up to date (Article 30)

  • If a change makes the hazard more severe, or adds supplemental elements, update the label "without undue delay".
  • For any other labelling change, the label must be updated "within 18 months" [25].

If you tell me the substance or mixture, I can pull its GB MCL entry and work out the exact label elements.

Q.02

When can I self-classify a chemical?

Under GB CLP, self-classification is the default. Manufacturers, importers and downstream users "shall classify" substances and mixtures under Title II (the Annex I criteria) before placing them on the market (Article 4(1)) [2]. The exception is a substance with an entry in the GB mandatory classification and labelling list (GB MCL list). You must use that entry and must not self-classify for the hazard classes it covers. You still self-classify for any hazard class the entry does not cover (Article 4(3)) [2].

Approach: I read the GB CLP Regulation as it applies in Great Britain: Articles 4-6, 9, 13 and 36-38. I did not look up individual entries on the GB MCL list.

When you self-classify

  • Substance not on the GB MCL list: you classify it for every hazard class [2].
  • Substance on the list: you classify it only for the hazard classes or differentiations that its entry does not cover [2].
  • Mixtures: manufacturers, importers and downstream users classify them under Title II, using the information on the mixture or on the substances in it (Articles 4(1) and 6) [26].
  • Substances you don't place on the market: you must still classify them where REACH requires registration or notification. This applies to manufacturers, producers of articles and importers (Article 4(2)) [2].

When you may rely on someone else's classification

  • Distributors established in GB may use a Title II classification made by another actor in the supply chain (Article 4(5)) [2].
  • Downstream users established in GB may do the same, "provided that they do not change the composition" of the substance or mixture (Article 4(6)). If you reformulate, you have to classify the new mixture yourself [2].
  • Everyone in the supply chain "shall cooperate" to meet the classification requirements (Article 4(9)) [2].

What self-classification involves

  1. Gather the available information:

    • test data
    • human and epidemiological data
    • other REACH Annex XI information
    • new scientific information
    • results from internationally recognised programmes

    The information must relate to the forms and physical states the substance is placed on the market in and can reasonably be expected to be used in (Articles 5 and 6) [27][26].

  2. Check that it is adequate, reliable and scientifically valid (Article 5(2)) [27].

  3. Evaluate it against the Annex I Parts 2-5 criteria (Article 9) [28]:

    • If the criteria can't be applied directly, use weight of evidence and expert judgement.
    • For mixtures with only substance or similar-mixture data, apply the bridging principles, or failing that the other Annex I methods.

  4. For mixtures, CMR and biodegradation/bioaccumulation use only the data on the substances in the mixture (Article 6(3)-(4)) [26]:

    • This applies to germ cell mutagenicity, carcinogenicity and reproductive toxicity, and to biodegradation and bioaccumulation within the aquatic hazard class.
    • If test data on the mixture itself show CMR effects that the substance data did not identify, you must also take those into account.

  5. Classify wherever the criteria are met: assign the hazard categories and the matching hazard statements (Article 13) [29].

Which substances normally end up on the GB MCL list

These are the substances most likely to have an entry you must follow rather than self-classify:

  • substances meeting the criteria for respiratory sensitisation Cat. 1, or germ cell mutagenicity, carcinogenicity or reproductive toxicity Cat. 1A, 1B or 2;
  • active substances under the plant protection or biocides regulations;
  • other hazard classes added case by case, with justification (Article 36) [30].

Two rules link self-classification to the list (Article 37(6)(b)-(c)) [31]:

  • If there is no entry for a hazard class, a manufacturer, importer or downstream user "may" propose one to the Agency.
  • If you hold new information that may change an existing entry, you "must" submit a proposal for a revised classification.

Neither rule applies to Northern Ireland suppliers sending qualifying Northern Ireland goods directly to GB (Article 37(7)) [32].

If you tell me the substance, I can check whether it has a GB MCL entry and which hazard classes you would still need to classify yourself.

Q.03