FAQs

REACH

REACH Regulation (EU Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals)

To help electronics and information industry manufacturers and professionals concerned with pollution control issues better understand the EU REACH chemical policy, SGS headquarters and ENVIRON jointly held an online seminar on January 26, 2010. The following summarizes key questions raised by participants and the corresponding responses for reference only.

Frequently Asked Questions

A.

The REACH regulation is an EU regulation and has direct legal effect in all EU member states. It is also valid within the EEA (European Economic Area), as it has been incorporated into the EEA Agreement. This means REACH is in force in Iceland, Liechtenstein, and Norway. However, imports from Switzerland (which is not part of the EU or EEA, but belongs to EFTA – the European Free Trade Association) into the EEA are treated as imports from non-EU countries.

Member states are best positioned to interpret how REACH is implemented within their own markets (including autonomous or overseas territories). Therefore, it is recommended that registrants contact the relevant regulatory helpdesks in their target markets to clarify detailed requirements.

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Substances, mixtures, and articles.

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Complete exemptions under REACH
  • Substances stored in EU customs or bonded areas without any processing
  • Transport of dangerous substances by land, sea, or air
  • Radioactive substances (covered by other regulations)
  • Substances exempted for national defense purposes
  • Non-isolated intermediates
  • Waste
Registration-only exemptions
  • Substances used for research and development (typically exempt for up to 5 years, extendable by another 5 years if necessary, limited to R&D quantities and listed customers)
  • Re-imported registered substances or substances contained in articles
  • Low-risk substances listed in REACH Annex IV
  • Substances listed in REACH Annex V
  • Active substances in biocides
  • Medicinal and veterinary products
  • Polymers
A.
Export of substances/preparations to EEA Conditions Required Actions Competent Authority Applicable Regulation
Various individual substances or individual substances in preparations > 1 ton / Year Pre-registration / Registration ECHA Article 6
Authorized substances under Annex XIV Should not be used Authorization application European Commission Article 56
Hazardous substances According to Annex XVII Cannot be sold if exceeding restriction limits Manufacturer Article 67 and Annex XVII
C & LP Almost all substances Notification ECHA Regulation 1272/2008
01
Export of substances/preparations to EEA Various individual substances or individual substances in preparations
Conditions > 1 ton / Year
Required Actions Pre-registration / Registration
Competent Authority ECHA
Applicable Regulation Article 6
02
Export of substances/preparations to EEA Authorized substances under Annex XIV
Conditions Should not be used
Required Actions Authorization application
Competent Authority European Commission
Applicable Regulation Article 56
03
Export of substances/preparations to EEA Hazardous substances
Conditions According to Annex XVII
Required Actions Cannot be sold if exceeding restriction limits
Competent Authority Manufacturer
Applicable Regulation Article 67 and Annex XVII
04
Export of substances/preparations to EEA C & LP
Conditions Almost all substances
Required Actions Notification
Competent Authority ECHA
Applicable Regulation Regulation 1272/2008
A.
Normal Use Concentration (SVHC) Tonnage/year Required Action Authority Regulation
Article releases chemical substances - > 1 t Registration / Pre-registration European Chemicals Agency (ECHA) Article 7 (1)
Article contains SVHC on the Candidate List >0.1% (w/w) 1000 ppm > 1 t Notification European Chemicals Agency (ECHA) Article 7 (2) (both concentration and tonnage must be met)
< 1 t Provide information and relevant safety information Immediately provide to recipient Article 33
< 1 t Provide information and relevant safety information Provide to consumers within 45 days Article 33
< 0.1% (w/w) 1000 ppm < 1 t
< 1 t
No action required No notification or communication required Depends on concentration
Article contains hazardous substances - - Production and sale prohibited if exceeding limits - Article 67 and Annex XVII
01
Normal Use Article releases chemical substances
Concentration (SVHC) -
Tonnage/year > 1 t
Required Action Registration / Pre-registration
Authority European Chemicals Agency (ECHA)
Regulation Article 7 (1)
02-1
Normal Use Article contains SVHC on the Candidate List
Concentration (SVHC) > 0.1% (w/w) 1000 ppm
Tonnage/year > 1 t
Required Action Notification
Authority European Chemicals Agency (ECHA)
Regulation Article 7 (2) (both concentration and tonnage must be met)
Tonnage/year < 1 t
Required Action Provide information and relevant safety information
Authority Immediately provide to recipient
Regulation Article 33
Tonnage/year < 1 t
Required Action Provide information and relevant safety information
Authority Provide to consumers within 45 days
Regulation Article 33
02-2
Normal Use Article contains SVHC on the Candidate List
Concentration (SVHC) < 0.1% (w/w) 1000 ppm
Tonnage/year < 1 t
> 1 t
Required Action No action required
Authority No notification or communication required
Regulation Depends on concentration
03
Normal Use Article contains hazardous substances
Concentration (SVHC) -
Tonnage/year -
Required Action Production and sale prohibited if exceeding limits
Authority -
Regulation Article 67 and Annex XVII
A.

As an article manufacturer outside the EEA, the Candidate List should be followed. This is because the recommendation list is not an official list, and imported articles from outside the EEA do not require authorization. "Authorization" applies to all substances of very high concern listed in Annex XIV, whether they are manufactured or imported as substances or mixtures. Imported articles are not subject to authorization. However, if these articles are manufactured within the EU, the manufacturer must obtain authorization for mixtures containing these substances.

A.
  Substances of Very High Concern (SVHC) Dangerous Substances
Product scope All products Defined according to restriction requirements
Threshold calculation unit Evaluated at the "article" level Mostly evaluated at the "homogeneous material" level
Threshold SVHC content in each article must not exceed
0.1% (w/w) = 1000 ppm = 1000 mg/kg
Different substances have specific limits under specific conditions
(according to restriction list requirements)
Substance type Monitored substances Restricted substances
Concentration Calculation
Substances of Very High Concern (SVHC) Threshold
Dangerous Substances Follow-up actions
Concentration calculation based on REACH-ECHA article definition
Substances of Very High Concern (SVHC) Fixed at 0.1% (w/w) = 1000 ppm = 1000 mg/kg for each item
Dangerous Substances If exceeding limits, safety use information must be provided according to Article 33
Mostly calculated based on "homogeneous material", with a few based on articles
Substances of Very High Concern (SVHC) Each substance has its own threshold
Dangerous Substances Exceeding limits leads to prohibition of sale and manufacture
Substance Type
Substances of Very High Concern (SVHC) Monitored substances
Dangerous Substances Restricted substances
A.
A.
A.

An article is an object which, during production, is given a specific shape, surface, or design that determines its function to a greater degree than its chemical composition. Therefore, an article is not necessarily a finished product. In other words, simple items such as electronic components and screws can also be considered articles.

A.

No. Although the components are assembled during use and shipped disassembled in one box, according to the Guidance on Requirements for Articles (version 2.0), each individual component is considered a separate article. For example: DIY furniture.

A.

The proposal has been rejected. Therefore, the concentration threshold is still calculated at the article level.

A.

"Restriction" refers to the limitations or prohibitions on specific uses of substances listed in Annex XVII. "Authorization" refers to a process by which ECHA grants permission for a company to use substances of very high concern for specific purposes. The Authorization List is selected from the SVHC Candidate List, and priority substances subject to authorization can be found in Annex XIV of the REACH Regulation.

A.

REACH does not provide a standard declaration or certificate format. Therefore, companies must determine their roles under REACH and comply with the relevant legal requirements accordingly. The European Chemicals Agency and international helpdesks can assist in answering questions. Third-party certification bodies may also help in understanding the regulatory framework and associated obligations.

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Restricted substances in Annex XVII should be assessed based on homogeneous materials.

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XRF is mainly used to detect elements with an atomic number greater than or equal to 17. It detects elements but cannot directly identify compounds. Since SVHCs are present in compound form, XRF is not suitable for SVHC detection.

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To our understanding, under Article 33 of REACH, there is no grace period for newly added SVHC substances. Information communication throughout the supply chain must be updated immediately.

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Printed materials and packaging are considered articles and are subject to the same requirements as other articles, with no differences.

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The CLP Regulation refers to the Classification, Labelling and Packaging of substances and mixtures (EC Regulation No. 1272/2008). It adopts the United Nations' Globally Harmonized System (GHS) within the EU to establish a unified system for chemical classification and labeling.

A.

Generally, no. However, manufacturers and importers of certain explosive articles are required to classify them. These must meet the definitions in Part 2.1 of Annex I of CLP before being placed on the market. Other articles are not subject to CLP classification, labeling, and packaging requirements. Nevertheless, article manufacturers or importers must still classify substances contained within articles under REACH Articles 7 and 9 if registration or notification obligations apply, including substances used for product and process oriented research and development (PPORD).

A.

Registration obligations apply only when the total quantity manufactured or imported by a registrant exceeds 1 tonne per year (see Article 6 of REACH for details).

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Yes. REACH requires assessment of their impact on human health and the environment. Potential registrants must first determine whether registration or exemption obligations apply, regardless of particle size. Once within the scope of REACH, different requirements may apply depending on size and hazard properties. As nanotechnology continues to evolve, additional requirements may be introduced to address specific characteristics of nanomaterials.

A.

In principle, SGS follows ECHA’s Guidance on Requirements for Articles and applies the threshold at the article level for testing. However, some countries—France, Austria, Belgium, Norway, Denmark, Germany, and Sweden—argue that this approach may cause a dilution effect. They therefore advocate applying the 0.1% (w/w) threshold at the component level rather than the entire article.

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