RoHS – Restriction of Hazardous Substances
The law affects all companies who:
- Manufacture EEE in the UK (Manufacturer obligations)
- Import EEE into the EU (Importer obligations. Note: May have manufacturer obligations in some situations)
- Export EEE from the UK to other EU Member States (Must comply with requirements in the other Member State(s))
- Rebrand other manufacturers EEE as their own (Manufacturer obligations)
- Sell EEE in the UK (Distributor obligations)
*Medical devices (excluding in vitro) from 22 July 2014; In vitro devices from 22 July 2016.
**Domestic monitoring and control instruments from 22 July 2014; Industrial monitoring and control instruments from 22 July 2017.
Manufacturers must:
- Ensure that EEE they produce meets the substance thresholds;
- Comply with the internal production control requirements of the ‘common framework for the marketing of products’ (Decision 768/2008/EC);
- Draw up technical documentation to support self-declaration;
- Draw up an EU declaration of conformity for each compliant product, translating it into the language of each Member State in which the product is available;
- Keep the technical documentation and declaration of conformity for at least ten years from the date the product was first placed on the market;
- Affix CE markings to each compliant product;
- Ensure that conformity is maintained throughout ‘series’ production;
- Ensure that the compliant products have information on them (or if size/nature prevent this, the packaging of the products) to identity the type, batch/serial number and manufacturer (including contact address);
- Keep a register of any non-compliant EEE produced and of any EEE recalled for non-compliance;
- Cooperate with the UK authorities (or other Member State authorities if appropriate) to demonstrate compliance;
- Advise authorities of their EEE suppliers (if appropriate) and customers if requested to do so.
Importers must:
- Ensure that EEE they import meets the substance thresholds;
Ensure the manufacturer complies with requirements 2-9 above; - Ensure that if they become aware of non-compliant EEE they inform the manufacturer and the UK authorities;
- Keep a register of any non-compliant EEE they place on the market and any non-compliant EEE they recall;
- Provide details of non-compliant EEE to relevant distributors;
- Take appropriate remedial action regarding the non-compliant EEE, recording the action and advising the UK authorities of the non-compliance and the corrective action taken;
- Cooperate with the UK authorities (or other Member State authorities if appropriate) to demonstrate compliance;
- Advise authorities of their EEE suppliers and customers if requested to do so.
NOTE: Where an importer places ‘own brand’ imported product on the market, they assume manufacturer, not importer, obligations.
Distributors must:
- Not make obligated EEE available if they believe it is non-compliant, informing the importer or manufacturer (as appropriate) and the UK authorities;
- Take appropriate remedial action regarding the non-compliant EEE, recording the action and advising the UK authorities of the non-compliance and the corrective action taken;
- Cooperate with the UK authorities (or other Member State authorities if appropriate) to demonstrate compliance;
Advise authorities of their EEE suppliers and customers if requested to do so.
A number of criminal offences are possible, including:
- Placing non-compliant EEE on the market;
- Failing to take appropriate corrective action where necessary;
- Failing to advise others (including the authorities) of non-compliant EEE;
- Failing to keep technical documentation and declarations of conformity;
- Failing to keep a register of non-compliant and recalled products;
- Failing to cooperate with authorities; and
- Falsely using a CE mark.
Penalties are currently up to £5,000 per offence with the possibility of unlimited fines and imprisonment for directors/statutory officers in some cases. RoHS offences are subject to criminal prosecution as they do not currently fall under the Civil Sanctions regime.
A defence of ‘due diligence’ is possible if you can show that you have taken all reasonable steps to be compliant.
Let us help you find the most cost effective way of complying with these Regulations.
Contact J Williams & Associates’ RoHS expert on 01488 649685 or email Jeff Williams for advice.
Manufacturer:
Importer:
Distributor:
CE Marking:
Place on the Market:
Homogeneous materials:
Restricted substances:
0.1% by weight in homogeneous materials for Lead, Mercury, Hexavalent Chromium, Polybrominated Biphenyls (PBB) and Polybrominated Diphenyl Ethers(PBDE);
0.01% by weight in homogeneous materials for Cadmium.
Exclusions by use:
Equipment designed to be sent into space;
Equipment specifically designed to be part of equipment to which RoHS does not apply, which can only fulfil its function as part of that equipment and can only be replaced by the same specifically designed equipment;
Exclusions by type:
Large scale fixed installations;
Transport (persons or goods), other than electric two-wheeled vehicles which are not type-approved;
Non-road mobile machinery made available exclusively for professional use;
Active implantable medical devices;
Photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications;
Equipment designed solely for the purposes of research and development only made available on a business-to-business basis.
Exemptions
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