EU Permits and Licenses

SDS + Label

Classification

Regulation (EC) No 1272/2008 on the Classification, Labelling and Packaging of substances and mixtures (CLP) establishes a classification and labelling system in the EU in line with the Globally Harmonised System (GHS). As an EU Regulation it directly applies in all EU Member States. Due to subsequent Adaptations to Technical Progress (ATPs) the CLP is in line with Revision 5 of the GHS.

SDS

Label

The result of a GHS classification is harmonized label elements including pictograms, signal words, hazard statements and precautionary statements. The content of the label is set out in Article 17 of the CLP. Due to the very specific and complex nature of potential requirements related to labels and packaging, please also refer to Titles III and IV and Annexes I and II of the CLP and the various guidance documents.

Trade Secrets

To avoid disclosing the full composition of a mixture in a safety data sheet, a supplier may request the use of an alternative chemical name for a substance in accordance with CLP Article 45. 

Occupational Exposure Limits

The EU Directive 98/24/EC establishes the workplace Occupational Exposure Limits (OELs) that are required to be disclosed in Section 8 of the EU SDS. The OELs for the EU Member State where the substance or mixture is placed on the market must also be included in the SDS.

As an implementation of Directive 98/24/EC, three lists of indicative occupational exposure limit values have been published.

Classification

Regulation (EC) No 1272/2008 (CLP)

Regulation (EC) No 1272/2008 on the Classification, Labelling and Packaging of substances and mixtures (CLP) establishes a classification and labelling system in the EU in line with the Globally Harmonised System (GHS). As an EU Regulation it directly applies in all EU Member States. Due to subsequent Adaptations to Technical Progress (ATPs) the CLP is in line with Revision 5 of the GHS. 

The CLP replaced the Dangerous Substances Directive (DSD, 67/548/EEC) and Dangerous Preparations Directive (DPD, 1999/45/EC) and republished (in CLP Annex VI Table 3.2) all of the DSD harmonised classifications. Under the CLP, there continue to be harmonised classification and labelling elements which are mandatory to use. These are published in Table 3.1 of Annex VI to the CLP and contain the DSD list, translated into GHS, and subsequently determined harmonized classifications. 

Transitional Period

The transitional period between the DSD classification system and the GHS-based CLP classification ended on June 1, 2015. From June 1, 2015 substances and mixtures must have classification and labelling in accordance with the CLP. For mixtures placed on the market before the June 1, 2015 deadline, the deadline for relabelling and repackaging is extended to June 1, 2017. Direct conversions of the classification and labelling In accordance with the DSD and DPD into the GHS-style classifications using the conversion table in Annex VII of the CLP is permitted.

The following types of substance are exempt from the CLP:

  • Radioactive substances regulated under Council Directive 96/29/Euratom;
  • Substances and mixtures which are subject to customs supervision as long as they do not undergo any treatment or processing if they remain in temporary storage or in a free zone or free warehouse under the intent of re-exportation;
  • Non-isolated intermediates;
  • Substances and mixtures for scientific research and development as long as they are not placed on the market and if they are used under strictly controlled conditions in accordance with EC workplace and environmental legislation;
  • Waste;
  • Substances and mixtures identified by Member States as national defence exemptions;
  • Substances and mixtures in the finished state intended for the final user for the following products:
    • Medicinal products as defined by EU Directive 2001/83/EC;
    • Veterinary products as defined by EU Directive 2001/82/EC;
    • Cosmetic products as defined by EU Directive 76/768/EEC;
    • Medical devices as defined by EU Directives 90/385/EEC and 93/42/EEC which are invasive or used in direct physical contact with the human body, and by EU Directive 98/79/EC;
    • Food or feedstuff as defined by EU Regulation (EC) No 178/2002.
  • Transport of dangerous goods by air, sea, road, rail or inland waterways

Classification

The CLP requires the classification and labelling of substances and mixtures before placing them on the market in the EU. The import of a substance or mixture automatically constitutes “placing on the market.” Substances not placed on the market or subject to Regulation 1907/2006 (REACH) should be classified by manufacturer/producer.

The CLP requires the use of the harmonised classifications for substances listed in Part 3 of Annex VI. Substances are listed under their EC, CAS and Index number. The regulation cites several notes for substances in Annex VI that may have a significant impact on classification and labelling. These notes precede Table 3.1 in Annex VI. A harmonised classification can be suggested by Member states or Industry by submitting a Dossier.

Substances with a harmonised classification still require a self classification for the hazard classes that are not covered by the entry in Annex VI. Substances that do not have a harmonised classification require self-classification by the manufacturer, importer or downstream user for all hazard classes. Mixtures must always be self classified by the downstream user.

The CLP is in line with Revision 5 of the GHS but it did not adopt all of the hazard classes suggested by the GHS. A full listing of hazard classes and categories is given in Table 1.1 in Part 1 of Annex VI to the regulation. The hazard classes and categories suggested by the GHS that the CLP does not cover are:

  • Flammable Liquids Category 4,
  • Acute Toxicity Category 5,
  • Skin Corrosion/Irritation Category 3,
  • Aspiration Hazard Category 2,
  • Acute Aquatic Category 2 and 3.

Certain other hazards are captured by additional hazard statements mandated by the EU.

Notification of Classification

Article 40 of the CLP requires notification of the Classification and Labelling information to the European Chemicals Agency (ECHA) for substances placed on the market in the EU.

Summary of ATPs

An Adaptation to the Technical Progress (ATP) is a major revision of the Annexes and certain Articles of the CLP regulation.

 PublicationRelevant DatesNew requirements/Updates
1st ATPCommission Regulation (EU) No 790/2009Issued: August 10, 2009 
Entered into force: September 25 2009
The regulation brings the entries from the 30th ATP & 31st ATP of Directive 67/548/EEC into Annex VI of CLP, resulting in the update of harmonized classifications in annex VI of CLP.
2nd ATPCommission Regulation (EU) No 286/2011Issued: March 10, 2011 
Entered into force: April 19, 2011
Includes various scientific-technical changes to the Annexes to the CLP Regulation. Changes regarding labelling provisions, inclusion of new sub-categories, the revision of classification criteria.
3rd ATPCommission Regulation (EU) No 618/2012Issued: July 10, 2012 
Entered into force: July 31, 2012 
Applied on December 1, 2013
Classification update for 16 substances.
4thATPCommission Regulation (EU) No 487/2013Issued: May 8, 2013 
Entered into force: June 21, 2013 
Applied to:

  • substances from December 1, 2014
  • mixtures from June 1, 2015.
New classification and labelling criteria for chemically unstable gases and non-flammable aerosols. New rules on the labelling of products that are corrosive to metals.
5thATPCommission Regulation (EU) No 944/2013Issued: October 2, 2015 
Entered into force: October 23, 2013 
Applied to:

  • substances from December 1, 2014
  • mixtures from June 1, 2015
Classifications of over 40 substances in Tables 3.1 and 3.2 of Annex VI of CLP regulation.
6thATPCommission Regulation (EU) No 605/2014Issued: June 5, 2014 
Entered into force: June 26, 2014 
Applied to:

  • substances from December 1, 2014
  • mixtures from June 1, 2015
New statements in Croatian language since the Accession of the Republic of Croatia.

Addition of substances to Annex VI list of harmonized classifications

7thATPCommission regulation (EU) No 2015/1221Issued: July 24, 2015 
Enters into force: August 13, 2015 
The amended harmonised classifications apply from January 1, 2017.
Updates the list of substances with harmonised classification and labelling in Part 3 of Annex VI to CLP Regulation.
8thATPCommission Regulation (EU) No 2016/918Issued: May 19, 2016
Changes apply from February 1, 2018
Changes in classification rules, test methods and labelling provisions
9th ATPCommission Regulation (EU) No 2016/1179Issued: July 19, 2016
The amended harmonised classifications apply from March 1, 2018. Table 3.2 shall be removed as of June 1, 2017.
Changes to the list of harmonised classifications in Annex VI: deletions of two substances and their classifications and amendments to existing classifications.

Deletion of Table 3.2 from Annex VI

draftDraft Commission Regulation of February 11, 2016Draft published: February 11, 2016 
Final date for comments: April 11, 2016
The EC proposes to add Annex VIII on harmonised information to be provided to national appointed bodies relating to emergency health response (Art. 45 CLP Regulation).

Cut-off Values/Concentration Limits

Where test data is not available for a mixture, for health and environmental endpoints, the GHS allows for classification based on the hazards of the substances in the mixture. The GHS usually defines the concentration at which a hazardous  substance causes a mixture containing that substance to be classified, for most hazards. These are known as Concentration limits / Cut-off values. Countries must additionally set the thresholds for mixture classification for certain hazards:

The European Union implements specific classification cut-off values and concentration limits for mixtures for certain hazard classes, prescribed in the CLP Regulation.

 

SDS

The requirements for SDSs in the European Union result from a combination of the responsibilities under the REACH and CLP regulations.

When is an SDS required?

Article 31 of the REACH Regulation states that a Safety Data Sheet (SDS) must be provided for a substance or mixture if any of the following three reasons apply:

  • The substance or mixture meets the criteria for classification as hazardous according to the CLP;
  • A substance is considered Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) in accordance with REACH Annex XIII of the REACH Regulation; or
  • If a substance is included on the Candidate list of substances (this list precedes being added to REACH Annex XIV which is subject to Authorisation).

An SDS must be supplied if requested by the recipient of the substance or mixture if it contains:

  • Greater than or equal to 1% by weight for non-gaseous mixtures and greater than or equal to 0.2% by volume for gaseous mixtures at least one of the substances posing a human health or environmental hazard;
  • Substances in an individual concentration of ≥ 0.1% by weight for non-gaseous mixtures with at least one substance that is
    • Carcinogenic Cat 2
    • Toxic to Reproduction Cat 1A, 1B and 2
    • Causes effects on or via lactation, or
    • Skin or Respiratory Sensitiser Cat 1, or
    • PBT, vPvB or an SVHC on the Candidate List
  • Substances in an individual concentration of ≥ 0.01% by weight for non-gaseous mixtures with at least one substance that is
    • Skin Sensitiser Cat 1A, 1B
    • Respiratory Sensitiser Cat 1A, 1B
  • Any substance for which a Community workplace exposure limit exists.

SDS must be updated and re-issued without delay as stated in Article 31(9) of REACH on the following occasions:

  • As soon as new information that may affect the risk management measures, or new information on hazards becomes available;
  • Once an authorisation has been granted or refused;
  • Once a restriction has been imposed.

An updated SDS must:

  • Be identified as: “Revision: (date)”
  • Be provided free of charge electronically or in paper form no later than the date on which the substance or mixture is first supplied
  • Be provided to former recipients over the previous 12 months
  • Include the registration number if the update is following the REACH registration

What must the SDS include?

REACH Annex II prescribes information contained in and the format of the SDS in the EU. The headings, subheadings as specified are required. Further subdivisions are acceptable but not required.

The SDS must be provided in the official language(s) of the Member State where the substance or mixture is being placed on the market.

With regard to the language requirement, ECHA has published a summary of the required languages for Safety Data Sheets in EU Member States. 

Extended Safety Data sheet (sSDS)

If a Chemical Safety Assessment (CSA) has been carried out as part of the REACH registration, and a Chemical Safety Report (CSR) was generated, then  the relevant Exposure Scenarios (ES) shall be placed in an Annex to the SDS of the pure substance. This is known as the extended Safety Data Sheet (eSDS). Exposure scenarios describe how the exposure to a hazardous substances can be controlled during use.

For mixtures, relevant information contained in incoming Exposure Scenarios of substances must be reflected in the SDSs of mixtures when available. 

Label

Labelling and Packaging

The result of a GHS classification is harmonized label elements including pictograms, signal words, hazard statements and precautionary statements. The content of the label is set out in Article 17 of the CLP. Due to the very specific and complex nature of potential requirements related to labels and packaging, please also refer to Titles III and IV and Annexes I and II of the CLP and the various guidance documents.

Hazard Pictogram

If several hazard statements are required for a hazardous substance or mixture, the precedence rules set out in Article 26 of the CLP should be applied.

Hazard Statements 

A full list of hazard statements (H-phrases) associated with the listed hazard codes is available in Annex III to the CLP.

The CLP adds additional statements that should be applied when appropriate. These EUH phrases are listed in CLP Annex II with the criteria for their application. Some of examples of the hazard-based phrases are as follows:

  • EUH001 – Explosive when dry
  • EUH014 – Reacts violently with water
  • EUH018 – In use, may form flammable/explosive vapour-air mixture
  • EUH019 – May form explosive peroxides
  • EUH044 – Risk of explosion if heated under confinement


In Part 2 of CLP Annex II, there are EUH phrases for mixtures containing certain types of substances, for example, lead, cyanoacrylates and active chlorine. These must also be applied where applicable. EUH phrases are considered part of supplemental label information.

Precautionary Statements 

A full list of precautionary statements (P-phrases) associated with the listed precautionary codes is available in Annex VI of the CLP Regulation. According to Article 28 of the CLP, not more than six precautionary statements shall appear on the label unless necessary to reflect the nature and the severity of the hazards. Instructions on how to reduce the number of precautionary statements on the label in compliance with the CLP regulation can be found in the Guidance on Labelling and Packaging in accordance with Regulation (EC) No 1272/2008.

Language

The label must be provided in the official language(s) of the Member State where the substance or mixture is being placed on the market. Multi-language labels are possible.

Trade Secrets

Alternative Chemical Names

To avoid disclosing the full composition of a mixture in a safety data sheet, a supplier may request the use of an alternative chemical name for a substance in accordance with CLP Article 45. In this case, ‘supplier’ may refer to any manufacturer, importer or downstream user or distributor who placing a substance or mixture on the market.

An alternate chemical name will only be granted where the substance is exclusively classified as the following:

  • any of the physical hazard categories,
  • acute toxicity (category 4),
  • corrosion / skin irritation (category 2),
  • serious eye damage/eye irritation (category 2),
  • specific target organ toxicity – single exposure (category 2 or 3),
  • specific target organ toxicity – repeated exposures (category 2) or
  • hazardous to the aquatic environment – chronic (category 3 or 4)

An alternative chemical name will not be granted if there is a Community workplace exposure limit.

From June 1, 2015, this process is mandatory in order to use an alternative chemical name on an SDS. 

Requests for the use of an alternative chemical name have to be created in IUCLID6 and submitted to ECHA through REACH-IT. 

Alternate chemical name requests are subject to a per substance per product fee, which is dependent on the company size and number of mixtures in the request. This fee range is laid out in EU Regulation No 440/2010.