Chemical legislation in cosmetics

• CLP


  classification, labelling and packaging of chemicals
• CLP:

  • hazard focus
  • horizontal legislation
  • health and safety executive
• REACH


  Registration, evaluation and authorisation of chemicals
• cosmetics regulation


  cosmetic ingredients and finished cosmetic products
• cosmetic regulation:

  • risk focused, human health (consumers of cosmetics)
  • vertical legislation
  • policy - office for product safety standards
  • enforcement - trading standards
• REACH:

  • risk focus, environment and occupational health
  • horizontal legislation
  • policy - department for environment, food and rural affairs
  • implementation - health and safety executive
• Risk = hazard/exposure
• classification


  assigning certain hazard class and category when toxicological data meets the classification criteria
• labelling


  communicating hazards throughout the supply chain, including to consumers, through labelling and safety data sheets (SDS)
• packaging

  general packaging standards to ensure the safe supply of hazardous substances and mixtures e.g- child resistant closures
• CLP regulation

  • hazard labelling rules for substances and mixtures
  • companies must determine the hazards of their substances or mixture
  • Aim is protection of health and environment
• when is CLP necessary?

  for cosmetic ingredients and bulk
• when is CLP not necessary?


  on finished cosmetic products
• self-classification


  • classification determined by manufacturers and importers of hazardous substances
  • mixtures must always be self-classified before being placed on the market - not subject to harmonised classification and labelling
• Mandatory classification


  • legally binding, minimum classification
  • mandatory classifications for GB CLP are found in the GB Mandatory classification and labelling list
• what does CMR stand for?

  carcinogenic, mutagenic, toxic to reproduction
• carcinogenic


  substance causing or being suspected to cause cancer or increase its incidence
• mutagenic


  substances causing heritable mutations or being suspected of causing heritable mutations
• toxic to reproduction


  substances causing or being suspected to causing adverse effects on sexual function and fertility in adults, as well as developmental toxicity in the offspring
• CMR hazard categories:

  • known to be CMR based on studies on humans
  • presumed to be CMR based on animal studies
  • suspected to be CMR based on limited evidence from animal/human studies
• CMR harmonised classification

  • HSE goes through process to evaluate chemical
  • HSE publishes mandatory classification of chemical to update annex of GB CLP
  • Is chemical used as a cosmetic ingredient?
  • is chemical classified as a CMR?
  • if yes to both, Article 15 of UK cosmetic regulation is triggered
• REACH is used for:

  • protection of human health and environment
  • chemical manufacturers submit registration dossiers to HSE - chemical data
  • communication through the supply chain on safe use of chemicals
  • management of chemical risks through evaluations, authorisation and restriction processes
• why is REACH important for cosmetic ingredients?


  • require REACH is they meet the scope of REACH - import/manufacturing tonnage, substances on their own or within mixtures
  • can be subject to REACH restrictions, authorisations or be listed on the candidates list as SVHCs
  • especially relevant in environmental concerns
• what does SVHC stand for?

  susbtances of very high concern
• what is cosmetic ingredient safety regulated by?


  • UK CR
  • UK REACH
• UK CR:

  • consumer health
  • professional user health
  • animal testing ban
• UK REACH:

  • worker (occupational) health
  • environmental safety
  • animal testing as a last resort
• REACH key principles:

  • no data, no market
  • identify and manage the risks linked to substances they manufacture and market
  • demonstrate to the authority how substances can be used safely
  • communicate the risk management measures to the users
• what substances does REACH cover?

  substances manufactured/imported > 1 tonne/year per legal entity
• Substances REACH covers:

  • substances on their own
  • substances in mixtures
  • substances that make up an article
• substances on their own


  cosmetic ingredients manufactured/imported as raw materials
• substances in mixtures


  cosmetic ingredients that make up a finished cosmetic product
• what are REACH’s obligations?


  • registration
  • authorisation
  • communication
  • chemical inventory
  • restriction
• who are REACH’s obligations?


  • manufacturers
  • importers
  • downstream users
  • distributors
• manufacturers 


  if you make chemicals yourself or to supply to other people
• importers


  if you buy chemicals from outside the market applicability
• downstream users


  companies using a substance on its own or in a preparation, in the course of their industrial/professional activities
• distributors


  stores and places on the market that sell a substance on its own or in a preparation, for third parties - includes retailers
• REACH registration process

  • companies must register substances in collaboration with companies registering the same substance
  • expert scientific committees asses manageability of substances risks
  • in long rub hazardous substances are substituted with less dangerous ones
• possible results of REACH registration:

  • Ban hazardous substances if the risk is too unmanageable
  • restrict use/make it subject to a prior authorisation
  • allowed use of chemical