REGISTRATION, EVALUATION, AUTHORISATION AND RESTRICTION OF CHEMICALS (REACH)

REACH has dramatically changed the way chemical substances are regulated in the European Union. P&G has fully supported the broad objectives of REACH and is committed to the protection of human health and the environment through the use of proper safety assessment and risk management. The principles guiding the REACH legislation have historically applied to most products P&G bring to market. This section will provide a brief overview of REACH, P&G’s role in the REACH process and the innovative leadership we have demonstrated.

  • What is REACH?

    Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)
    REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemical Substances. It is an EU regulation which came into force in 2007 to ensure a safe use of chemicals within the European Union.

    The main objectives of REACH are:
    • To improve the protection of human health and the environment from the risks of chemicals (as more information will be known about over 30,000 existing substances);
    • To maintain competitiveness of the EU chemicals industry REACH requires manufacturers and importers of chemical substances to register chemical use in a volume-triggered system. Registration dossiers containing information on the hazards, exposures and risks associated with the uses of the chemical substances, will be reviewed by ECHA. Uses of substances of very high concern must be authorized if used at >0.1%. Importantly, REACH brought to an end the different treatment of new and existing substances.
  • The REACH Process

    The REACH process entails different important stages: Registration, Evaluation and Authorisation and Restriction.
    • Registration

      Registration is the key component of REACH. It is compulsory to register substances manufactured in or imported into the EU according to a volume-triggered system. Failure to register a substance for a specific tonnage band by the deadlines stated in the REACH text means that the substance cannot be manufactured or imported at that tonnage band after the deadline.

      The European Chemicals Agency (ECHA) is responsible for managing the Registration system, receiving and reviewing registration dossiers and developing guidance to assist producers, importers and the competent authorities in implementing these provisions.

      Downstream users of a chemical need to communicate with manufacturers or suppliers to make sure that the use they intend for the chemical has been assessed and concluded to be safe. If not, the downstream user will have to perform its own safety assessment and report to the Agency.

    • Evaluation

      There are two types of evaluation: dossier evaluation and substance evaluation.

      Dossier evaluation is compulsory for any proposals involving experiments on animals. It is essentially designed to minimize use of animals. Dossier evaluation may also be carried out in order to verify compliance of registration dossiers.

      Substance evaluation will take place if a substance is suspected to have an unacceptable risk to human health or the environment by requesting more information from industry.

      The two types of evaluation may result in a request for additional information. Importantly, the burden of proof is reversed under REACH: the safety of chemicals placed on the market must be ensured by industry rather than the authorities.

    • Authorisation

      Substances of very high concern are subject to authorisation by ECHA with regard to particular uses. These are substances considered to be:
      • Category 1A or 1B CMRs (carcinogenic, mutagenic or toxic to reproduction);
      • PBTs (persistent, bio-accumulative and toxic);
      • vPvBs (very persistent, very bio-accumulative); or
      • having serious and irreversible effects to humans and the environment
      If the risks arising from the use of such a substance can be adequately managed, authorisation is to be granted for that specific use and for a specific timing. If they cannot, ECHA is to consider the level of risk and the possible socio-economic benefits of using the substance, and whether alternatives exist. On this basis, ECHA is to decide whether the substance should be authorised.
    • Restriction

      The restriction procedure provides a safety net, making it possible to manage risks which are not adequately covered by other provisions of the REACH system. Proposals for restrictions may consist of conditions for the manufacture or use of a substance and/or for placing it on the market, or possibly for prohibiting such activities, if necessary. Such proposals are to be prepared by Member States or the European Commission in the form of a structured dossier.
  • P&G and REACH

    P&G is a downstream user, an importer and a manufacturer of chemicals so preparing for and complying with REACH at all points of the supply chain has been an important preoccupation over the last decade. Since 2005 there has been a central P&G multifunctional team working on REACH compliance.

    All P&G business units are collaborating with upstream and downstream customers to ensure that all REACH commitments are met. Where P&G acts as an EU manufacturer or importer of a substance, we have fulfilled our pre-registration & registration obligations. Where P&G is a downstream user, we have followed up with our suppliers to ensure they meet their obligations.

    The REACH objective of ensuring a safe use of chemicals has been a long-term fundamental anchor to P&G’s manufacturing philosophy. In any product formulation, P&G’s strategy has always been to rigorously test and evaluate in order to use the substances that are the safest for humans and the environment.

    Regarding Substances of Very High Concern (SVHC), P&G has taken steps to understand the potential presence of any SVHCs and to work with our suppliers to guarantee that P&G products are REACH compliant. Specifically, we are working with our suppliers to ensure that the potential presence of any SVHC in marketed articles is below the threshold of 0.1%.

  • Innovation and chemical safety

    From the early days of the REACH legislation process P&G has been engaged in developing the best means for regulating the safe use of chemicals. More than 15 P&G scientists actively contributed to the preparation of guidelines to support the practical implementation of REACH. Our leadership in scientific research, laboratory depth and long history of safety-oriented testing has made P&G’s science-driven sustainability philosophy a good fit for REACH.
    P&G has led the way in developing techniques that reduce the need for animal testing. These innovations have been vital in avoiding the needless suffering of animals that an increased evaluation burden might have otherwise been imposed under REACH.

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