Lactic Acid Classification

Frequently Asked Questions

• Introduction

  As your ingredient partner, Corbion is committed to ensuring you are kept informed at all times about changes to any aspect of the products we supply to you. This includes, of course, changes in the regulatory status of products we provide, as we know such changes may affect the way products and materials are labelled, packed, handled and transported.

  • The Classification of L(+) - Lactic acid (CAS Number 79-33-4) will change. It will be classified as a substance corrosive for the skin, based on a new recommendation from the European Chemicals Agency (ECHA).
  • A new Annex VI of the CLP (Classification, Labelling and Packaging) Regulation (EC) 1272/2008 was published on August 11, 2020. This Annex includes L(+) - Lactic acid with a classification containing new hazard phrases for product labels: H314 ‘Causes severe skin burns and eye damage’ and EUH 071 ’corrosive to the respiratory tract‘ (only valid in the EU) instead of the current H315 ‘Causes skin irritation’ and H318 ‘Causes serious eye damage.’
  • The hazard pictogram on the labels stays the same (Corrosive). Therefore, product handling should adhere to the local regulation for corrosive products.
  • The industry is allowed a period of 18 months from publication of the new regulation to implement this change. This means the change must go into effect by March 1, 2022.
  • The new classification implies that lactic acid will fall under the ADR regulation where applicable. Lactic acid will be included in the generic UN number “UN 3265 for class 8 - Corrosive liquid, acidic, organic, n.o.s.” This will be implemented no later than  March 1, 2022.
  • Please note that this classification does not apply to lactic acid salts (lactates). 

• What does this change in classification mean for products and formulations (mixtures) that contain L-Lactic acid?

  All products containing >5% L-Lactic acid must be classified as Skin Corrosive Cat 1C, according to GHS calculation rules, unless testing results on your product prove otherwise; test results always take precedence over calculation rules. Be sure to take into consideration any other skin corrosive ingredients that may be present in your product. This >5% limit also applies to buffered lactic acid mixtures where lactates are added.

• What does this change in classification mean for lactic acid powder?

  The classification change applies to the chemical L-Lactic acid (CAS 79-33-4), i.e. no matter in which physical form it is available.

• Does this change affect the classification of lactic acid with the general CAS# 50-21-5 and the optical isomer D-Lactic acid (CAS# 10326-41-7)?

  Although, strictly speaking, these substances are not included in the classification, labelling and packaging (CLP) regulation Annex VI (translation of the GHS for EU), Corbion as the global market leader chooses to harmonize the classification and labelling of all lactic acid CAS#. The reason is simple: D-Lactic acid does not behave differently on skin than the L-isomer.

• What does this change in classification mean for lactic acid derivatives like lactates, esters, lactylates, PLA, etc.?

  This change has no impact on lactic acid derivatives; under GHS, they will retain their current classifications.

• What happens if I store lactic acid in bulk at my site?

  The new classification requires that lactic acid be stored as a corrosive material. Storage regulations are defined at the national level (for example, MIE-APQ in Spain, PGS15 in the Netherlands, GefstoffVO/TRGS 510 in Germany). For detailed guidelines, please refer to your country-specific
  legislation.
  

• What happens if I store packed goods in my warehouse?

  The new classification requires that lactic acid be stored as a corrosive material. Storage regulations are defined at the national level (for example MIE-APQ in Spain, PGS15 in the Netherlands, GefstoffVO/TRGS 510 in Germany). For detailed guidelines, please refer to your country-specific legislation.

• What is the impact of this change on transport classification?

  The new classification as skin corrosive implies that lactic acid will fall under the ADR regulation where applicable. Lactic acid will be included in the generic UN number “UN 3265 for class 8 - Corrosive liquid, acidic, organic, n.o.s.” Corbion will apply the ADR requirements by 1 March 2022 at the latest, the date by which the new GHS classification (Annex VI) must be applied.

• Will Corbion update their REACH dossier?

  As the new classification of L-Lactic acid will apply beginning 1 March 2022, Corbion will update the REACH dossier accordingly.

• What does this mean for non-European countries?

  All GHS countries apply the same calculation rules for skin irritation/corrosion. Corbion will apply the EU change from Skin Irritant Cat 2 into Skin Corrosive Cat 1C also in all other countries.

• What does the change in classification of L-Lactic acid mean for companies that import lactic acid (as a stand-alone material or in formulations) into Europe?

  Companies importing lactic acid must apply the EU-GHS (CLP) rules, i.e., use the new classification of L-Lactic acid.

• What does this mean for non-European producers of lactic acid selling outside of Europe?

  Producers outside Europe must apply the GHS rules of the country where they put the lactic acid on the market.

• What does that mean for packaging of lactic acid?

  Packaging for lactic acid must be UN compliant, Class 8 - PGIII.

• What is EUH071?

  This hazard phrase is a EU only requirement and does not fall under the GHS. This statement is: “corrosive to the respiratory tract.”

• Link to the draft regulation amending Annex VI to CLP, ATP15

  https://ec.europa.eu/transparency/regdoc/rep/3/2020/EN/C-2020-3151-F1-EN-MAIN-PART-1.PDF