What laws are in place?
Hazardous chemicals in products or processes under health and safety legislation must by law be reviewed, replaced and substituted with safer alternatives. Under the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulations, the onus of safe chemical management is the responsibility of companies. The legislation is in place to protect people and the environment from the harmful consequences and effects of dangerous chemicals. In accordance with the REACH Regulation (Regulation (EC) No. 1907/2006), a safety data sheet (SDS) should be provided with any hazardous chemical. All hazardous chemicals (substances and mixtures) placed on the market must be classified, labelled and packaged according to the CLP Regulation (EC) No. 1272/2008 since 1st June 2015. CLP requires manufacturers, importers or users of substances or mixtures to classify, label and package their hazardous chemicals appropriately before placing them on the market. Following the CLP regulation best practices allows for chemical safety information to be clearly communicated to all stakeholders so they can take the appropriate steps to mitigate against any potential chemical risks.
What are REACH regulations?
REACH was introduced in 2007, since its inception it has established guidelines for the collection of information on the properties and hazards of substances. Companies must register detailed dossiers on substances to the scientific committee at ECHA. Each substance is reviewed on a case by case basis and evaluated to ascertain the likelihood of harmful effects of the substance and whether the degree of risks can be managed safely. Authorities have the power to ban substances, restrict their use or make them subject to prior authorisation.
Manufactures and importers are required to register all chemicals manufactured or imported over 1 tonne per annum. All registrations go through an evaluation process which consists of three phases:
- Dossier evaluation
- Compliance check
- Examination of testing proposals
- Substance evaluation
- Drafting a decision
- Member states involvement
- ECHA’s decision
Follow up to ECHA’s decision
- Dossier evaluation
- Substance evaluation
Substances of Very High Concern
All submissions are available transparently on the ECHA website in a database of substances registered of SVHC (substances of very high concern).
The criteria in REACH, Article 57 outlines what constitutes SVHC:
- Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with Regulation (EC) No 1272/2008 (the CLP regulation);
- Substances which are persistent, bio-accumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII of the REACH Regulation;
- Substances which are very persistent and very bio-accumulative (vPvB) in accordance with the criteria set out in Annex XIII of the REACH Regulation;
- Substances giving rise to an equivalent level of concern to substances meeting the above criteria. Such substances may have endocrine disrupting properties or have properties, that although not meeting the criteria for being a CMR, PBT or vPvB, there is scientific evidence of probable serious effects to human health or the environment. Such substances will be identified on a case-by-case basis.
The authorisation process is significant to ensure that all risks posed by SVHC are thoroughly considered and enough safety measures put in place. In addition, it often means replacing substances with safer alternatives. Substances meeting the above criteria are placed on one and often the following two lists:
- The Candidate List
This list is updated twice a year by ECHA. It contains substances of very high concern and as a result necessitate legal obligations for companies using these substances. Once a substance is on the Candidate List suppliers must declare this information to consumers. The emphasis is for manufacturers to remove substances and replace with safer alternatives. Here is the most up to date Candidate List
- The Authorisation List
Substances from the Candidate List are added to the Authorisation List according to how ECHA prioritises them. The prioritisation by ECHA considers the hazardous properties of the substance, use pattern and volume on the EU market. Once on the Authorisation List a “Sunset Period” is placed on each substance, this is basically a period of time that the substance is prohibited until authorisation is granted for the user.
The Authorisation List is currently updated once a year and available on the ECHA website.
Certain substances that are deemed by ECHA as being too risky and unacceptable to the environment and human health may be limited or banned. If this happened the manufacture, sale or use of that substance may be ceased. Final decisions on restrictions are made by the ECHA, Member States and relevant experts. Once a final restriction has been decided, all manufacturers, importers, distributors and downstream users including retailers must comply. It is up to the authorities in each member state to govern enforcement. Substances restricted under REACH can be found here.
New way of managing chemical substitution
The introduction of tighter legislation from REACH and increases in fines from health and safety governing bodies has resulted in the need for sophisticated chemical management. Data management is key and technological advancements have facilitated improvements. Historically manual processes to try gather chemical data resulted in reactive processes that often were too slow to keep up with dynamic supply chain needs. The slow and logistically unsound distribution of chemical information to end user’s in a timely fashion to facilitate safe work practices was also a huge issue. Gathering safety sheets containing hazard information and extracting GHS classification information on chemicals instantly is now best practice. Data on hazard types being compared in real time with SVHC, authorisation lists, Candidate Lists and Restricted Lists is now a necessity.
Companies and end users need to be instantly able to run reports to identify chemical performance to REACH demands. Also, they must review inventory data to make smarter decisions early in the procurement stage on substituting harmful substances to protect workers and the environment.