Classification, Labelling and Packaging (CLP) Regulation: An Overview

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CLP Regulation
The Classification, Labelling and Packaging (CLP) Regulation classifies and regulates substances, mixtures and some articles in order to protect people and the environment.

The scope of the regulation also includes consumer products mainly composed of substances, such as candles, or finger paints.

In this guide, we explain how the CLP Regulation applies to those substances and products, including requirements regarding labelling, packaging, and lab testing.


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What is the CLP regulation?

The CLP Regulation, which is administered by the European Chemicals Agency (ECHA), aims to ensure that human health and the environment receive a “high level of protection”, and it is based on the United Nations’ Globally Harmonised System (GHS).

It covers hazard classification, labelling, packaging, and documentation requirements regarding substances listed in the Classification and Labelling (C&L) Inventory, such as:

  • Benzyl pivalate
  • Triparanol
  • Phthalimidoacetic acid
  • Cyclobutanemethanol

What is the difference between the CLP Regulation and REACH?

Both the CLP and REACH regulations are administered by the ECHA. The CLP Regulation mandates companies to correctly classify, label, document and package their chemicals and products before putting them on the market.

On the other hand, the REACH Regulation mainly sets substance restrictions and registration requirements.

Below, we list some of the manufacturers’ responsibilities under the CLP and REACH regulations.

CLP Regulation REACH Regulation
a. Classification requirements

b. Labelling requirements (e.g. hazard pictograms)

c. Documentation requirements (e.g. safety data sheet (SDS))

d. Packaging requirements (e.g. child-resistant fastenings)

a. Registration requirements

b. Provide customers with Substance of Very High Concern (SVHC) information (if needed)

c. Substance restrictions (e.g. Annex XVII)

d. Documentation requirements (e.g. safety data sheet (SDS))

Note that, while some of these requirements only apply to substances, there might be requirements that also apply to articles.

Examples

In the table below we provide the specific requirements for two substances. Note that the general CLP and REACH requirements (e.g. documentation) still apply.

Substance CLP REACH
Bis (2-ethylhexyl)phthalate (DEHP) Pictogram “Serious health hazard” required in the packaging of substances and mixtures containing DEHP a. SVHC: Notification to ECHA required if DEHP amount in articles is > 0.1% by weight

b. Annex XVII: DEHP amount must be < 0.1% in articles (alone or in combination with DBP, DBP, BBP, DIBP)

Lead a. Pictogram “Serious health hazard” and “Hazardous to the environment” required in the packaging of substances and mixtures containing DEHP

b. If the lead content exceeds 0.15% of the total weight of paints and varnishes, the packaging should include the statement provided in Part 2.1. of Annex II

a. SVHC: Notification to ECHA required if lead amount in articles is > 0.1% by weight

b. Annex XVII: Lead amount must be < 0.05% in jewelry or articles that children might place in the mouth

Product scope

The CLP Regulation covers substances and mixtures that have either undergone harmonised classification (listed in Annex VI) or are covered by the CLP requirement for self-classification. The regulation also covers some types of articles, such as explosives.

Product examples

Below are a few examples of consumer products that might be covered by the regulation. We also briefly provide information on what substances they might contain, as well as the labelling requirements according to the GHS hazard classification symbols.

Scented candles

Scented candles might contain essential oils that are regulated by the CLP Regulation.

One example of a regulated essential oil is “Citrus sinensis (Rutaceae) peel, terpene-free”, which is deemed to be toxic, and might result in long-term harm to aquatic life. It might also have negative effects on human health, such as:

  • Death, if swallowed and entered airways
  • Serious eye irritation
  • Allergic skin reaction

As such, packaging for scented candles might require a label that includes the signal word “Danger!” as well as the pictograms for:

  • “Serious health hazard”
  • “Health hazard/Hazardous to the ozone layer”
  • “Hazardous to the environment”

You can find more information about the CLP pictograms in this page.

Finger paints

Finger paints might contain fatty acids that are regulated by the CLP Regulation, such as “Fatty acids, C8-18”.

These substances might cause the following negative human health effects:

  • Severe skin burns
  • Severe eye damage

As such, packaging for finger paints might need to carry the signal word “Danger!” as well as the pictogram for “Corrosive”.

Detergents

Detergents might contain substances that are regulated by the CLP Regulation.

One example of such a substance is “Sulfuric acid, mono-C9-11-alkyl esters, sodium salts”. This substance is a flammable solid that harms aquatic life, and might cause the following negative human health effects:

  • Serious eye damage
  • Skin irritation
  • Respiratory irritation

As such, packaging for detergents should bear the signal word “Danger!” as well as the pictograms for:

  • “Corrosive”
  • “Health hazard/Hazardous to the ozone layer”

Exemptions

The CLP Regulation does not cover substances and mixtures in certain forms that, when in their finished states, are meant for the end consumer. This includes:

  • Cosmetic products
  • Invasive medical devices
  • Medicinal products
  • Veterinary medicinal products
  • Food additives and flavourings in foodstuffs
  • Additives in feeding products
  • Food or feeding products in animal nutrition

You can find more details in Article 1(5) of the CLP Regulation.

Substance classification

The C&L Inventory contains information regarding the classification and labelling of notified and registered substances.

As the C&L Inventory is updated regularly, manufacturers should check their substance classifications in a regular way and update their documentation, if necessary.

C&L Inventory

The C&L Inventory contains the following two main types of substances:

a. A list of classifications, as well as the names of substances, both of which are harmonised under the GHS.

b. Substances that importers or manufacturers have registered with ECHA.

In the table below, we list three examples of substances listed in the C&L Inventory.

Substance name Hazard classification and labelling information
Methyldioctylamine Must bear the signal word “Warning!” and the pictograms for the following two hazard classifications:

a. “Hazardous to the environment”

b. “Health hazard”

Exo-2-bornanamine Must bear the signal word “Warning!” and the pictograms for the following two hazard classifications:

a. “Flammable”

b. “Health hazard”

(Z,Z)-cycloocta-1,5-diene Must bear the signal word “Danger!” and the pictograms for the following four hazard classifications:

a. “Flammable”

b. “Serious Health Hazard”

c. “Health hazard”

d. “Hazardous to the Environment”

Substance restrictions

The C&L Inventory does not provide restrictions for listed substances. However, it might be used as a basis for restricting substances under other regulations and directives. We provide examples of these regulations in the subsections below.

Further, there are requirements (e.g. danger pictograms) for specific substances (or mixtures containing specific substances).

In some cases, “special rules” (e.g. labelling statements) apply to mixtures that contain specific substances above a certain limit. For example, the packaging of paints and varnishes that contain an amount of lead higher than 0.15% of the total weight of the mixture, should bear the statement provided in Part 2.1 of Annex II.

Toy Safety Directive

Importers and manufacturers should ensure that the design and manufacture of toys are such that the chemical mixtures or substances within do not pose adverse health risks to human health.

Toys, or their components or parts, must not contain substances that the CLP Regulation has classified as carcinogenic, mutagenic, or reprotoxic (CMR) of categories 1A, 1B, or 2, except when said substances:

  • Do not exceed established concentrations
  • Remain inaccessible to children
  • Are determined to be safe
  • Cannot be replaced by an alternative substance

You can find more details under Annex II of the Toy Safety Directive.

Cosmetics Regulation

According to Article 15 of the regulation, the use of the following substances in cosmetics is prohibited:

a. Substances classified as CMR substances, of category 2, under Part 3 of Annex VI of the CLP Regulation.

b. Substances classified as CMR substances, of category 1A or 1B under Part 3 of Annex VI of the CLP Regulation.

However, exceptions might apply. You can refer to the Cosmetics Regulation for additional information.

REACH Regulation

Substance classification under the CLP Regulation might trigger importer or manufacturer obligations under REACH.

For instance, if you use a substance that was classified in the C&L Inventory as CMR category 1A or 1B, or even persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), you should check if the substance was:

  • Identified as a SVHC and included in the Candidate List
  • Included in REACH Annex XIV as subject to authorisation

Notification requirements

Importers and manufacturers must notify the ECHA when they place substances on the market that are:

a. Classified as hazardous under the CLP Regulation; or

b. Classified as hazardous under the CLP Regulation, and existent in a mixture exceeding the concentration limits stipulated in Annex I to CLP.

Note that if you have already notified the ECHA because your substances needed to be registered according to the REACH requirements, you do not need to submit an additional notification under the CLP Regulation.

Documentation requirements

Importers and manufacturers might need to provide documentation such as the following:

a. Safety data sheets (SDS), which should be drafted in according to the requirements of Article 31 of REACH, and include information such as:

  • Identification of the substance and company
  • Hazards identification
  • Composition
  • Measures (e.g. first-aid, fire-fighting)
  • Handling and storage information
  • Physical and chemical properties
  • Other relevant information (e.g. toxicological, disposal, regulatory, transportation)

b. Other classification documentation (e.g. information gathered for compliance with REACH)

c. Lab test reports (if applicable). You can find more information about lab testing on this page.

Labelling requirements

Importers and manufacturers must label the packaging of substances and mixtures (including consumer products such as finger paints) when those substances and mixtures are classified as hazardous.

Label content

Article 17 of the CLP sets the following labelling requirements for the packaging of substances and mixtures that are classified as hazardous:

a. The supplier’s name, address, and phone number.

b. The nominal quantity of the packaged substance or mixture, unless this number appears elsewhere on the package.

c. Product identifiers (name and identification number).

d. Hazard pictograms.

e. Signal words.

f. Hazard statements.

g. Appropriate precautionary statements.

h. A section for supplemental information.

Special rules

Part 2 of Annex II sets special labelling rules for certain mixtures. Here we list two examples:

a. The label on the packaging of adhesives based on cyanoacrylate should include the statement:

“Cyanoacrylate. Danger. Bonds skin and eyes in seconds. Keep out of the reach of children”

b. The label on the packaging of mixtures intended for brazing or soldering containing cadmium (alloys) should include the statement:

“Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by the manufacturer. Comply with the safety instructions”

Exemptions

Part 1.5.2 of Annex I sets exemptions for certain labelling requirements. As an example, the hazard and precautionary statements might be omitted if the content of the package does not exceed 125 ml and the substance or mixture is classified as oxidising gases of category 1.

Packaging requirements

Article 35 of the regulation specifies safety requirements for packaging that contains hazardous substances or mixtures. For instance, you should ensure that:

a. The package’s design and construction prevent the contents from leaking (except where more specific safety devices are required).

b. The packaging and fastening materials must not be easily damaged by the contents, or potentially form dangerous compounds with the substances within.

c. The packaging and fastenings must be durable and sturdy enough to not come loose, and that they can withstand foreseeable handling circumstances.

d. Packaging that is fitted with interchangeable fastenings must be designed in such as way that the package can handle repeated refastening without content leakage.

Such packaging of hazardous substances or mixtures meant for the general public should not have a design or shape that might entice interest in children or look similar to a foodstuff or medical container.

Annex II

Annex II of the regulation specifies additional packaging requirements:

a. Packaging of hazardous substances must be fitted with child-resistant fastenings.

b. Child-resistant fastenings on reclosable packages must comply with the EN ISO 8317 standard.

c. Child-resistant fastenings on packages that are non-reclosable, must comply with the EN 862 standard.

d. Packages must carry a tactile danger warning, the technical specifications of which must conform to the EN ISO 11683 standard.

Lab testing requirements

Per the CLP Regulation, importers and manufacturers must collect applicable and available information regarding a substance or mixture’s hazardous properties.

In practice, this means that you might need to have your substances and mixtures tested to prove compliance with the requirements of the CLP Regulation (e.g. correctly classify a mixture, or create a SDS that is factually correct).

Test methods

Test methods concerning physical hazards can be found in Part 2 of Annex I to CLP. Here we list some examples:

a. ISO 6503 – Paints and varnishes – Determination of total lead – Flame atomic absorption spectrometric method

b. ISO 817 – Refrigerants – Designation and safety classification, Annex C: – Method of test for burning velocity measurement of flammable gases

Additionally, Article 13(3) of REACH sets the requirements for test methods that should be used to evaluate human health and environmental hazards. This includes:

a. Test methods laid down in specific Commission Regulations

b. International test methods recognised by the European Commission or the ECHA

c. Other test methods that meet the conditions set out in Annex XI to REACH

Test labs

Below, we list companies that offer services related to the CLP Regulation, such as testing, SDS creation and review, or gap analysis:

  • (USA & EU)

    FREE CONSULTATION CALL (US, EU & UK)

    • Request a free 30-minute call with Ivan Malloci to learn how we can help you with:
    • Find product requirements
    • Certification and labeling
    • Lab testing

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    Disclaimer: The Site cannot and does not contain legal advice. The legal information is provided for general informational and educational purposes only and is not a substitute for professional advice. Accordingly, before taking any actions based upon such information, we encourage you to consult with the appropriate professionals. We do not provide any kind of legal advice. THE USE OR RELIANCE OF ANY INFORMATION CONTAINED ON THE SITE IS SOLELY AT YOUR OWN RISK.

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    Sources: Our articles are written in part based on publicly available information, and our own practical experience relating to product compliance. These are some of the primary sources we use:

    • ec.europa.eu
    • echa.europa.eu
    • ecfr.gov
    • cpsc.gov
    • ftc.gov
    • fcc.gov
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