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What Are the 4 New Substances in RoHS 2 (2015/863) [RoHS vs Reach Compliance]

When importing goods into the EU, it is important to consider both REACH and RoHS. But often that is easier said than done.

The specific requirements of these regulations can be difficult to understand as the regulations do change regularly. Besides that, RoHS and REACH can easily be mistaken for each other. In this article, you´ll learn about the REACH and RoHS compliance and the key difference between RoHS and REACH.

What Is the RoHS Directive?

RoHS stands for the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (EEE). It is a product-level compliance based on the European Union’s Directive 2002/95/EC.

Products that are compliant with RoHS  directive do not exceed the allowable amounts of: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls and polybrominated diphenyl ethers. Learn more about the RoHS in greater detail from our RoHS webinar below!

Who Needs to Comply with RoHS?

The RoHS directive applies to manufacturers, authorised representatives, importers and distributors of EEE products, such as large and small household appliances, computing and communications equipment, consumer electronics and more.

Key Compliance Changes in the RoHS 2 (Directive 2011/65/EU)

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.

Key Compliance Changes in the RoHS 3  (Directive 2015/863/EU)

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.

Companies are often required to prove their RoHS compliance in Europe. In order to do so, they can provide a  letter issued by an employee of the company. But many companies also rely on third-party organisations, like us at HQTS, to help with the RoHS regulatory testing. You can download a sample RoHS test report to see how we document the process.

RoHS Restricted Substances

The RoHS regulation specifies maximum levels by weight for 10 restricted materials, 6 which were applied under the first RoHS and 4 of which were added under the 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) – uUsed 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 monitors 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.

What Product Categories Fall Under the EU RoHS Directive?

The RoHS directive applies to products in categories 1 to 11 and RoHS. It also applies to all wires, cables and associated connectors both internal and external. We´ve listed the 11 product types below.

  • 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 one of the most important directives in the global electronics industry, as it protects the health and safety of consumers, clients and companies as well as the environment. 

The RoHS directive is a result of the EU’s commitment to reducing environmental pollution from electronic waste (e-waste) generation and its negative impact on human health.

Restricted materials provide occupational danger during manufacturing, as well as pollute the environment and landfills when they are disposed of.

The RoHS Directive 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 affect a person’s health and well-being.

How to Become RoHS Compliant?

RoHS compliance can be achieved by reducing the amount of hazardous substances used in your EEE products. But in general, you want to get a RoHS certification that can confirm that the proportion of hazardous substances in your products is within the maximum – and to do so, you´ll need to go through a RoHS certification process.

4 Steps to Become RoHS Compliant

Follow these steps to get a RoHS certification.

  1. Test your products  – Extraction testing is carried out either on site or at a laboratory to determine the values of the restricted RoHS substances.
  2. Process Audit – Inspect all applicable manufacturing processes used towards RoHS compliance on-site.
  3. Review your Documents– 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.
  4. Certification Statement – A RoHS Certificate of Compliance (also known as a Certificate of Conformity or Declaration of Conformity)will be issued after a successful audit.

What Is the REACH Regulation?

The EU brought REACH regulation 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 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 their users.

REACH Restricted Substances and Regulations

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

List of REACH Restricted Substances:

  • 1-methyl-2-pyrrolidone (NMP)
  • 1,1-Dichloroethene
  • 1,1,1,2-Tetrachloroethane
  • 1,1,2-Trichloroethane
  • 1,1,2,2-Tetrachloroethane
  • 1,4-Dichlorobenzene
  • 2-(2-butoxyethoxy) ethanol (DEGBE)
  • 2-(2-methoxyethoxy) ethanol (DEGME)
  • 2-naphthylamine and salts
  • 4-Aminobiphenyl xenylamine and salts
  • 4-Nitrobiphenyl
  • Acrylamide
  • Ammonium and compounds: nitrates, polysulphides, sulphide, hydrogen sulphides, inorganic salts
  • Arsenic and compounds
  • Asbestos fibers
  • Azocolourants and Azodyes
  • Benzene
  • 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)
  • Chloroform
  • Chromium VI and compounds
  • CMR substances in textiles
  • Coal tars: low-temp oils, alkalines, acids, extracts, phenols, distillates; anthracene, creosote, naphthalene oils
  • Cyclohexane
  • Di-µ-oxo-di-n-butylstanniohydroxyborane / Dibutyltin hydrogen borate C8H19BO3Sn (DBB)
  • Dichloromethane
  • 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)
  • Hexachloroethane
  • Lead and compounds
  • Mercury and compounds
  • Methanol
  • 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
  • Pentachloroethane
  • 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
  • Toluene
  • Trichlorobenzene
  • 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.

Requirements to Become REACH Compliant

REACH regulations state 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 major element of the REACH regulation is the requirement to communicate information on chemicals up and down the supply chain and the obligations for REACH compliance are dependent upon the composition and the number of chemicals concerned.

The REACH compliance 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 Is the Difference?

REACH vs RoHS compliance cover many different areas.But both are equally important; the difference between RoHS and REACH is the following. 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).

A major difference between RoHS and REACH is that REACH is much broader than RoHS. While RoHS covers only six hazardous materials and focuses on those used in the manufacturing of electronics, 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 and REACH Compliance Comparison Table

This comparison table shows some differences between REACH and RoHS compliance:

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

What Are the Testing Requirements for REACH and RoHS?

The testing requirements are different for REACH and RoHS compliance. REACH includes SVHC screening and testing according to Annex XV11 Restricted list and RoHS testing includes X-Ray fluorescence screening and chemical analysis. If you want to learn more about the testing, we´ve written dedicated articles earlier about the most common question of RoHS testing and REACH testing. You can also download our free REACH and RoHS testing reports.

Conclusion: RoHS vs REACH Compliance: All Things You Need To Know

RoHS and REACH cover many areas – and they are equally important. RoHS is a product-specific vertical legislation that focuses on restricting hazardous substances in electrical and electronic equipment (EEE). While REACH is broader and targets and controls the use of thousands of substances and is not limited to the electronics industry.

As such, becoming RoHS or REACH compliant can be challenging. Particularly because the testing requirements and overall compliance procedure differs.

HQTS can carry out an in-house third-party RoHS and REACH compliance product and material testing service. We have world-class testing facilities that will ensure your products are within the acceptable range of compliance before they are sent to the European Union.  Send an inquiry for our RoHS or REACH compliance testing today!

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