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Updates to REACH and RoHS come into force

Friday 12th July 2019

REACH and RoHS regulations updated 

REACH and ROHS legislation and requirements have been updated and can prove a confusing and complicated area for many organisations. RoHS puts an absolute restriction on specific substances, whereas REACH is a process of registration, evaluation, authorisation and restriction of certain substances. In this article, we summarise the two, and list the areas of change. Subscribers to the Spedan iSHEQ tool can access further information and guidance by logging in and searching either 'REACH' or 'RoHS' on the iSHEQ dashboard. 

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

REACH is a European Union regulation and stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It is important legislation for the control of chemicals in Europe and aims to protect human health and the environment from the risks that can be posed by them, whilst enhancing the competitiveness of the EU chemicals industry. In short, REACH aims to control the use of such substances by authorisation, whilst encouraging industry to substitute these for safer ones. 
To meet the overall aim, REACH has several key objectives: 

  • To make those who place chemicals on the market, i.e. manufacturers and importers, responsible for understanding and managing the risks associated with their use
  • To allow the free movement of substances on the EU market
  • To enhance innovation in the EU chemicals industry and its competitiveness
  • To promote the use of alternative methods for assessing the hazardous properties of substances 

REACH impacts almost all UK business sectors as most businesses use some form of chemicals in their day to-day operations. Even businesses that don’t consider themselves to be involved with chemicals can be affected by REACH and others may rely on chemicals in some way without realising it, for example, in their manufacturing processes or for keeping premises clean. Examples of chemicals include paints, metals, glues, solvents, or cleaning materials. 

If you are a Chemicals manufacturer or importer, then you will have to collect information about the properties and uses of these chemical substances if they amount to more than one tonne a year. This information is passed to the European Chemicals Agency (ECHA) to assess the hazards and risks that a substance may pose and how those risks can be controlled. ECHA will check the quality of the information submitted and work with local National Competent Authorities to evaluate substances with hazardous properties for potential regulatory action. 

Some substances have hazards that have serious consequences (e.g. they cause cancer or cause long term environmental pollution) are referred to as ‘Substances of Very High Concern’ (SVHC) and are listed on the ECHA ‘Candidate List’. Companies making or supplying these will have to work within clear legal parameters, which will include the requirement to communicate the information to their supply chain. 

Downstream users, those people or organisations that use chemical substances in preparations or in manufactured goods (articles) do not need to register any substances or chemicals they use with ECHA, as this will already have been done by the manufacturers of the original chemical substances. To protect themselves, a company may choose to declare this in a ‘REACH position statement’, which they will need to periodically review, as new articles or substances are added to the candidate list by ECHA.

Coming into force on 2nd July this year, the regulation restricts the sale of certain spray products to the general public. These mixtures are currently used in proofing or impregnating aerosol sprays, exposure to which can result in serious acute lung injury. 

Restriction of Hazardous Substance (ROHS 3) 

The Restriction of Hazardous Substances (RoHS) particularly impacts the electronics and electrical products industries, although certain chemicals and other compounds may be affected as well. The original RoHS directive was made law in the European Union in 2002 and restricted six hazardous materials found in electrical and electronic products. 

In 2011, the Directive was updated (known as RoHS 2) and required CE marking of products, and added further requirements for additional compliance records to be kept. In 2015, a further update was made and the Directive (Directive 2015/863) is known as RoHS 3. RoHS 3 adds four additional restricted substances (phthalates) to the original list of six substances. The full list of substances is now: 

  • Cadmium (Cd): < 100 ppm
  • Lead (Pb): < 1000 ppm
  • Mercury (Hg): < 1000 ppm
  • Hexavalent Chromium: (Cr VI) < 1000 ppm
  • Polybrominated Biphenyls (PBB): < 1000 ppm
  • Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm
  • Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
  • Benzyl butyl phthalate (BBP): < 1000 ppm
  • Dibutyl phthalate (DBP): < 1000 ppm
  • Diisobutyl phthalate (DIBP): < 1000 ppm

The additional items are phthalates, which are often used as plasticisers. The deadline for implementing RoHS 3 is 22 July 2019. There are some exemptions for Medical Device manufactures, which are in place until 2021. 

RoHS is very closely associated to the Waste Electrical and Electronic equipment directive, so any applicable products for the EU market must pass WEEE compliance and carry the "Wheelie Bin" mark. 

Will Brexit have an impact? 

The impact on the management of REACH depends if the withdrawal is supported with a deal or no deal. What we do know is the regulatory requirements will not disappear and responsibilities for registration formally submitted to ECHA will be transferred to ‘UK REACH’. 

It is likely that if you are importing or exporting articles or substances over one ton from the UK there will be major changes to the way to manage REACH.

The Department for the Environment and Rural Affairs have prepared comprehensive guidance on each scenario

What should you be doing to meet RoHS 3 or REACH? 

If you are a manufacturer or importer
If you fit into these categories for REACH, you should have submitted your application, which contains product information and is referred to as a dossier, to ECHA and had it approved so the products can be placed on the market from the 2nd July 2019.  

If you are a downstream user
If you are a downstream user of chemicals or products, it is a good idea to get assurance from your supply chain that the products you use are within the appropriate limits for either REACH or RoHS. You can then use this information with confidence in your Certificates of Conformity.  

Subscribers to the iSHEQ online tool can access the full text and guidance by searching 'REACH' on the iSHEQ dashboard

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Adam Faiers - Director

Adam has been working on Quality and Environmental management systems for most of his career in small, medium and corporate organisations. A keen advocate of the ISO approach as a platform for improvement, Adam ensures that systems are practical and useful for Managers and Staff to use.

Following a number of years working on software development projects, Adam has diversified into Information Security and Business Continuity management. Keen to formalise his industry experience, he is currently undertaking a Diploma in Business Continuity Management at Buckingham University.

Adam has a PhD from Cranfield University and now supports the MSc Environmental Management programmes through the advisory panel and visiting lectures.

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