Reach and RoHS need to both be considered when importing goods into the EU but, the specific requirements of these regulations can be difficult to understand as the regulations do change regularly. For example, since 2019, new restricted substances, marking requirements and regulated product types have been added to the directive.
What is the RoHS Directive?
RoHS stands for the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment. It is a product-level compliance based on the European Union’s Directive 2002/95/EC. Products that are compliant with this directive do not exceed the allowable amounts of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyl’s and polybrominated diphenyl ethers.
The RoHS directive applies to manufacturers, authorised representatives, importers and distributors of products including large household appliances, small household appliances, computing and communications equipment, consumer electronics, lighting, power tools, toys and sports equipment and automatic dispensers such as ATM machines.
RoHS 2 came into effect in 2013 with expanded directives to include more products such as electric cables and spare parts. It also stepped up documentation requirements as RoHS 2 requires compliant recordkeeping from everyone in the supply chain, not just from the company selling the product.
RoHS 3 was then added in July 2019 which includes 11 new category products and four new restricted substances which have now been added to the directive. The four substances are mainly used for insulation and the category 11 products include all other electronic and electrical equipment not covered by other categories.
Often, companies prove RoHS compliance with a letter issued by an employee of the company. Also there are third-party testing services available that will test the products to ensure the levels of the restricted materials are compliant.
What it Covers
RoHS specifies maximum levels by weight for 10 restricted materials, 6 of which were applied under the original RoHS and 4 are added under RoHS 3.
- Cadmium (Cd) – used in electronic equipment, car batteries, metal coatings, and pigments. Known human carcinogen that affects multiple organ systems
- Lead (Pb) – used in solder, lead-acid batteries, electronic components, cable sheathing, x-ray shielding and in the glass of cathode-ray tubes
- Mercury (Hg) – used in batteries, switches, and thermostats and fluorescent lamps
- Hexavalent Chromium (Cr VI) – used in chrome plating, dyes and pigments
- Polybrominated Biphenyls (PBB) – BBs are flame retardants found in computer monitor and TV plastic enclosures. They have been found in indoor dust and air through evaporation
- Polybrominated Diphenyl Ethers (PBDE) – added to plastic enclosures to make them difficult to burn
- Bis(2-Ethylhexyl) phthalate (DEHP) – DEHPs are used to soften PVC and vinyl insulation on electrical wires and in medical tubing
- Benzyl butyl phthalate (BBP) – These are used to soften PVC and vinyl insulation on electrical wires
- Dibutyl phthalate (DBP) – DBPs are part of the dinaphthalene family used to soften PVC and vinyl insulation on electrical wires
- Diisobutyl phthalate (DIBP) – These are also used to soften PVC and vinyl insulation on electrical wires.
The RoHS directive applies to products in categories 1 to 11 and RoHS also applies to all wires, cables and associated connectors both internal and external.
- Category 1: large household appliances – refrigerators, washers, stoves and air conditioners
- Category 2: small household appliances – vacuum cleaners, hair dryers, coffee makers and irons
- Category 3: computing and communications equipment – computers, printers, copiers, phones, satellite TV, phone tower equipment and antennas
- Category 4: consumer electronics – TVs, DVD players, stereos and video cameras
- Category 5: lighting – lamps, lighting fixtures, light bulbs (some fluorescents are exempt)
- Category 6: power tools – drills, saws, nail guns, sprayers, lathes, trimmers and blowers
- Category 7: toys, leisure and sports equipment – videogames, treadmills, talking dolls and Fitbits
- Category 8: medical devices and equipment – including in-vitro-diagnostic medical devices
- Category 9: monitoring and control equipment – thermostats, smoke detectors and fire alarms including industrial applications
- Category 10: automatic dispensers – vending machines and ATM machines
- Category 11: catch all – all other electronic and electrical equipment not covered under the other categories. Included are; 2-wheeled electric vehicles, electronic nicotine delivery systems (ENDS) such as e-cigarettes and vape pens; electrical cables that are less than 250V working voltage.
Why is RoHS Important?
RoHS is extremely necessary and vitaly important for the health and safety of consumers, clients and companies as well as to protect the environment. Restricted materials provide occupational danger during manufacturing, as well as pollute the environment and landfills when they are disposed of. RoHS is also linked with the Waste Electrical and Electronic Equipment Directive (WEEE), which encourages the design of electrical products to be environmentally safe with regard to both recycling and recovery. The 6 banned materials are extremely hazardous to the environment and landfills and exposure to these substances can affects a person’s health and well-being.
How Do You Become RoHS Compliant?
To become RoHS compliant, the following steps are needed to take place for RoHS certification:
- Testing – extraction testing is carried out either on site or at a laboratory to determine the values of the restricted RoHS substances
- Process Audit – inspect all applicable manufacturing processes used towards RoHS compliance on-site
- Documentation Review – review the Bill of Materials, technical file, assembly drawings, materials declarations, test reports, and conformance/compliance certificates from all supplierThe technical file must contain general product descriptions and design structure information, risk assessment of materials, parts and subassemblies, conformity information on materials, parts and subassemblies, manufacturing documentation and records and harmonised standards, specifications and conformity procedures.
- Certification Statement – after a successful audit, a RoHS Certificate of Compliance (also known as a Certificate of Conformity or Declaration of Conformity) is issued.
What is the REACH Regulation?
The EU brought REACH into force in June 2007 (EC 1907/2006) and it aims to protect human health and the environment through better and earlier identification of the properties of chemical substances. This is achieved in four processes – registration, evaluation, authorisation, and restriction of chemicals. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.
REACH ensures companies comply with the regulation and they must identify and manage the risks linked to the substances they manufacture and market in the EU. They must demonstrate how the substance can be used safely and they must communicate the risk management measures to the users.
What it Covers
Registration: chemical producers are required to register safety data for all chemicals produced
Evaluation: experts from member states and the European Agency evaluate safety data for higher volume chemicals and other chemicals of concern
Authorization: chemicals that are “substances of very high concern” (SVHC) are to be phased out and replaced with safer alternative chemicals
Restriction: chemicals may be completely banned or some uses of the chemicals can be restricted.
The following is the list of REACH restricted substances:
- 1-methyl-2-pyrrolidone (NMP)
- 2-(2-butoxyethoxy) ethanol (DEGBE)
- 2-(2-methoxyethoxy) ethanol (DEGME)
- 2-naphthylamine and salts
- 4-Aminobiphenyl xenylamine and salts
- Ammonium and compounds: nitrates, polysulphides, sulphide, hydrogen sulphides, inorganic salts
- Arsenic and compounds
- Asbestos fibers
- Azocolourants and Azodyes
- Benzidine and salts
- Bis (pentabromophenyl) ether (decaBDE)
- Bisphenol A
- Bromoacetic acid esters: Butyl bromoacetate, Propyl bromoacetate, Ethyl bromoacetate, Methyl bromoacetate
- Cadmium and compounds
- Chloroethene and Chloroethylene (Vinyl chloride)
- Chromium VI and compounds
- CMR substances in textiles
- Coal tars: low-temp oils, alkalines, acids, extracts, phenols, distillates; anthracene, creosote, naphthalene oils
- Di-µ-oxo-di-n-butylstanniohydroxyborane / Dibutyltin hydrogen borate C8H19BO3Sn (DBB)
- Dimethylfumarate (DMF)
- Diphenylether, octabromo derivative C12H2Br8O
- Directive 1999/45/EC dangerous liquids
- EC 1272/2008 Annex VI Part 3 carcinogens, mutagens, and reprotoxins per category
- 1A, 1B (Table 3.1) or 1, 2 (Table 3.2)
- Flammable gases (Cat 1,2), liquids (Cat 1,2,3), solids (Cat 1,2) that in water emit flamable gases (Cat 1,2,3) of pyrophoric liquids, solids (Cat 1)
- Lead and compounds
- Mercury and compounds
- Methylenediphenyl diisocyanate (MDI)
- Monomethyl -tetrachlorodiphenyl methane (Ugilec 141)
- Monomethyl-dibromo-diphenyl methane bromobenzylbromotoluene, mixture of isomers (DBBT)
- Monomethyl-dichloro-diphenyl methane (Ugilec 121/21)
- Nickel and compounds
- Nonylphenol C6H4(OH)C9H19 and Nonylphenol ethoxylates
- Nonylphenol ethoxylates (NPE) (C2H4O)nC15H24O
- Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5)
- Organostannic compounds
- Pentachlorophenol and salts, esters
- Perfluorooctanoic acid (PFOA) and salts
- Phenylmercury: 2-ethylhexanoate, acetate, neodecanoate, octanoate, propionate
- Phthalates: 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich, 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich, Di-isononyl phthalate (DINP), Di-isodecyl phthalate (DIDP), Di-n-octyl phthalate (DNOP)
- Phthalates: Dibutyl phthalate (DBP), Benzyl butyl phthalate (BBP), Bis (2-ethylhexyl) phthalate (DEHP)
- Polybromobiphenyls, Polybrominatedbiphenyls (PBB)
- Polychlorinated terphenyls (PCTs)
- Polycyclic-aromatic hydrocarbons (PAHs): Benzo[a]pyrene (BaP), Benzo[e]pyrene (BeP), Benzo[a]anthracene (BaA), Chrysen (CHR), Benzo[b]fluoranthene (BbFA), Benzo[j]fluoranthene (BjFA), Benzo[k]fluoranthene (BkFA), Dibenzo[a,h]anthracene (DBAhA)
- Soap bark powder (Quillaja saponaria) and saponine derivatives
- Tris (2,3 dibromopropyl) phosphate
- Tris (aziridinyl) phosphinoxide
Why is REACH Important?
REACH is a regulation which has been adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes hazard assessments of substances in order to reduce the number of tests on animals.
REACH applies to all chemical substances for both industrial processes but also in our day-to-day lives. For example in cleaning products and paints as well as in articles such as clothes, furniture and electrical appliances.
How Do You Become REACH Compliant?
REACH regulations state that it is the responsibility of the manufacturer or importer to know the chemicals in each of their products and to prove the safety of all the substances used. The average manufacturer could be required to register up to 3,000 substances.
One of the major elements of the REACH regulation is the requirement to communicate information on chemicals up and down the supply chain and the obligations for REACH compliance is dependent upon the composition and the amount of chemicals concerned.
The requirement is to collect, collate and submit data to the European Chemicals Agency (ECHA) on the hazardous properties of all substances manufactured or imported into the EU in quantities above 1 tonne per year. Certain substances of high concern, such as carcinogenic, mutagenic and reproductive toxic substances (CMRs) will have to be authorised. Chemicals will be registered in three phases according to the tonnage of the substance evaluation; more than 1000 tonnes a year, or substances of highest concern, must be registered in the first 3 years; 100-1000 tonnes a year must be registered in the first 6 years and 1-100 tonnes a year must be registered in the first 11 years.
RoHS vs REACH; What’s the Difference in 2021?
Both REACH and RoHS cover many different areas, but both are equally important; the REACH legislation controls the risks associated with chemical substances throughout their whole life cycle and applies to all substances, while RoHS is a product-specific vertical legislation which focuses on hazardous substances in electrical and electronic equipment (EEE).
REACH is much broader than RoHS. While RoHS covers only six hazardous materials and focuses on those used in the manufacturing of electronics and REACH will target and control the use of thousands of substances and is not limited to the electronics industry.
However, as public pressure mounts to add more substances under REACH, companies will be pressured to stay up to date with new registration rules and deadlines and to help ensure compliance with RoHS and REACH, many companies will take advantage of electronic component databases.
RoHS vs REACH Comparative Table
This table shows some differences between RoHS and REACH:
|RoHS is evaluated at the homogenous material level||REACH is evaluated at the article level|
|RoHS bans substances that are present in electrical equipment that is within the directive||REACH applies to all chemicals used to make a product|
|Instructions but no enforcement on how to comply||Has a defined process that must be followed for risk and chemical management|
|RoHS is an EU Directive 2002/95/EC. RoHS is directive 2011/65/EU||REACH is a regulation|
RoHS and REACH Testing Requirements
The testing requirements are different for RoHS and REACH. REACH includes SVHC screening and testing according to Annex XV11 Restricted list and RoHS testing includes X-Ray fluorescence screening and chemical analysis.
HQTS can carry out an in-house third-party RoHS and REACH compliance product and material testing service. HQTS offer a world-class testing facility ensuring that your products are always within the acceptable range of compliance before they are sent to the European Union. This comprehensive package ensures our extensive industry experience and know-how are applied to every step of your export process to ensure total compliance upon delivery. The ability to trust your supplier is the key to sourcing successfully. Let HQTS be your eyes on the ground with our factory audit, which keeps you updated in real time and allows you to see exactly who is on the other end of your deals. Click here to see more details and to contact HQTS.