What is the difference between REACH and California Proposition 65?

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REACH California Proposition 65 comparison

REACH and California Proposition 65 are two regulations restricting dangerous substances in the EU and in the US State of California, respectively. These two regulations overlap to a large extent in terms of the substances that are subject to restrictions.

That being said, the two differ in terms of the specific bans, limitations, test methods, labeling, and registration requirements that apply.

In this guide, we summarize the main differences between the regulations and feature some examples of restricted substances.


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Product scope

Both regulations restrict a wide range of substances and chemicals. REACH covers substances and articles that might contain these substances. Conversely, California Proposition 65 mainly covers substances in products that might be found in the house or the workplace, or that might be released into the environment.

In any case, both are relevant when importing or manufacturing consumer products.

REACH

REACH regulates the usage of hazardous substances, as well as products that might contain them. Under the REACH regulation, importers and manufacturers must ensure that those products are safe for the environment and human health.

In practice, this means that REACH covers all products, even if certain types of products (e.g. cosmetics) are exempted from some of its provisions. Here are some examples of covered product categories:

  • Watches
  • Pet products
  • Toys
  • Food contact materials
  • Electronics
  • Equipment

California Proposition 65

California Proposition 65 requires companies to warn Californians if their products contain chemicals that cause birth defects, cancer, or other reproductive harm.

It mainly covers products that can be found in the house or the workplace, including:

  • Apparel
  • Electronics
  • Jewelry
  • Toys

However, it might also cover chemicals that are released into the environment, such as byproducts of chemical processes (e.g. exhaust from motor vehicles).

REACH and California Proposition 65 comparison

REACH California Proposition 65
Product scope a. Substances

b. Articles

a. Products that may contain those chemicals

b. Chemicals released into the environment

Substances Restricted substances listed in:

a. SVHC Candidate List

b. Annex XVII

c. Annex XIV (Authorization List)

Restricted substances listed in the Proposition 65 List
Limits a. Generally expressed as a weight percentage (e.g. 0.1% w for SVHC)

b. Might be expressed as migration limits (e.g. 0.05 μg/cm² per hour)

Safe harbor levels, expressed in micrograms per day (μg/day):

a. No Significant Risk Levels (NSRLs) – for chemicals that cause cancer

b. Maximum Allowable Dose Levels (MADLs) – for chemicals that are toxic for reproduction, or

c. Both

Documentation A test report is required to prove compliance with relevant restrictions

For substances:

a. Technical dossier

b. Chemical safety report

c. Safety Data Sheet (SDS)

a. A test report is required to prove compliance with relevant restrictions
Labels Substances: Might require compliance with the CLP Regulation labeling requirements Warning (including a symbol, the word “WARNING” and a warning statement)
Registration Substances: registration is mandated when the quantity of manufactured of substances exceed 1 tonne per year

Articles: when the concentration of SVHC exceeds 0.1% by weight, it is mandatory to register this info on the SCIP database

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Substance restrictions

REACH restricts a wide range of substances and lists them in Annex XVII and the SVHC Candidate List. California Proposition 65 restricts substances that might cause cancer, birth defects, or other reproductive issues. These substances can be found in the Proposition 65 List.

REACH

The REACH Regulation provides different lists of restricted substances. The SVHC Candidate List includes substances that might harm the environment and human health. On the other hand, Annex XVII lists substances that are more hazardous, and therefore, are either restricted or prohibited.

SVHC Candidate List

The ECHA, which administers REACH, may propose to have a substance identified as an SVHC if:

a. It is carcinogenic, mutagenic, or toxic for reproduction (CMR) in categories 1A and 1B.

b. According to Annex XIII of REACH, it is persistent, bioaccumulative, and toxic (PBT).

c. It may cause issues to the human endocrine system.

The SVHC Candidate List contains more than 200 substances. Here we provide some examples:

  • Melamine
  • DCHP
  • Cadmium carbonate
  • Dibutyltin dichloride (DBTC)
  • Arsenic acid

Suppliers of articles must submit relevant information to the SCIP database when the concentration of any SVHC in their products exceeds 0.1% by weight.

Annex XVII

Annex XVII to REACH lists more than 70 hazardous substances whose use is either restricted or prohibited.

Some substances are restricted to a specific percentage by weight – for example Chromium IV is restricted to 0.0003% by dry weight of leather articles in contact with the skin..

Other substances have migration limits, or both limits by weight and migration limits. For example, lead is limited to 0,05% in article unless it can be shown that its rate of release is lower than 0.05 μg/cm2/hour.

Here are some examples of substances listed in Annex XVII:

  • Benzene
  • Mercury
  • Chloroform
  • Toluene
  • Methanol

Annex XIV

Annex XIV, that is the “Authorisation list”, includes substances that are already in the SVHC Candidate List. The difference is that, if a chemical is also listed in Annex XIV, it can only be placed in the market if you obtain an authorization, or the use of the substance is exempted.

California Proposition 65

California Proposition 65 mandates that the state maintains a list of substances that cause cancer, reproductive harm, or birth defects. This list currently has around 900 chemicals and includes:

  • Lead
  • Cadmium
  • Chromium VI
  • Arsenic
  • Nickel
  • BBP
  • DEHP

Limits

We list in the table below several examples of substances regulated by both REACH and California Proposition 65. The regulations express restrictions differently; for instance, substances are usually restricted to a percentage by weight under REACH, while chemicals are restricted to micrograms per day under California Proposition 65. Note that some substances might be regulated by only either REACH or California Proposition 65.

Substance REACH California Proposition 65
Lead a. Candidate List: 0.1% by weight

b. Annex XVII: 0.05% by weight (e.g., for bracelets, brooches)

a. NSRL: 15 µg/day

b. MADL: 0.5 µg/day

Cadmium a. Candidate List: 0.1% by weight

b. Annex XVII: 0.01% by weight (e.g., of paints on painted articles and plastic materials on rigid PVC applications)

a. NSRL (inhalation): 0.05 µg/day

b. MADL (oral): 4.1 µg/day

Chromium VI a. Annex XVII: 0.0003% by dry weight of leather articles in contact with the skin a. NSRL: 0.001 µg/day

b. MADL (oral): 8.2 µg/day

Arsenic a. Annex XVII: Prohibited from use (e.g., in boat hulls) a. NSRL: 10 µg/day, or 0.06 µg/day if by inhalation
Nickel a. Annex XVII: Weekly migration limit (e.g., less than 0.2 μg/cm² for ear piercings, 0.5 μg/cm²/week for necklaces) As nickel subsulfide:

a. NSRL: 0.4 µg/day

BBP a. Candidate List: 0.1% by weight

b. Annex XVII: 0.1% by weight of plasticized material (e.g., in childcare articles and toys)

a. MADL (oral): 1200 µg/day
DEHP a. Candidate List: 0.1% by weight

b. Annex XVII: 0.1% by weight of plasticized material (e.g., in childcare articles and toys)

a. NSRL: 310 µg/day (adult)

b. MADL: 4200 µg/day (intravenous; adult), 600 µg/day (intravenous; infant), 210 µg/day (intravenous; neonatal infant)

c. MADL (oral): 410 µg/day (intravenous; adult), 58 µg/day (intravenous; infant), 20 µg/day (intravenous; neonatal infant)

DBP a. Candidate List: 0.1% by weight

b. Annex XVII: 0.1% by weight of plasticized material (e.g., in childcare articles and toys)

a. MADL: 8.7 µg/day

REACH limits

The substance restriction limits under REACH are expressed either as migration limits or as percentages by weight of the article or material containing the substance. Annex XVII might set specific restrictions that only apply to some categories of products.

California Proposition 65 limits

California Proposition 65 lists the restrictions as safe harbor levels, as either a No Significant Risk Level (NSRL) or a Maximum Allowable Dose Level (MADL), both of which are expressed in micrograms per day (μg/day). For instance, ethylene oxide has an NSRL of 2 μg/day and a MADL of 20 μg/day.

Labeling

In this section, we outline REACH and California Proposition 65 labeling requirements.

REACH and CLP

To the best of our knowledge, REACH does not specify labeling requirements for articles. However, Article 10 of REACH mandates an hazard label if your substance requires registration. The requirements for such label can be found in the Classification, Labelling and Packaging (CLP) Regulation.

California Proposition 65

The Office of Environmental Health Hazard Assessment (OEHHA), which administers Proposition 65, requires you to place a warning label on your product if said product can expose users to substances on the Proposition 65 List. The warning label should contain:

a. A triangular warning symbol, comprising an exclamation mark

b. The word “WARNING:” in bold, black, and capital letters

c. The warning statement

d. The name of the listed chemical (or chemicals) that prompted the warning.

e. OEHHA’s Proposition 65 warning internet address – www.P65Warnings.ca.gov.

Here is an example of a warning:

WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause [cancer, birth defects, or other reproductive harm]. For more information, go to www.P65Warnings.ca.gov”

Exemptions

According to the OEHHA, you are exempt from adhering to California Proposition 65’s warning requirements if you are:

  • A business with fewer than 10 employees
  • A government agency
  • (USA & EU)

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    Disclaimer: The Site cannot and does not contain legal advice. The legal information is provided for general informational and educational purposes only and is not a substitute for professional advice. Accordingly, before taking any actions based upon such information, we encourage you to consult with the appropriate professionals. We do not provide any kind of legal advice. THE USE OR RELIANCE OF ANY INFORMATION CONTAINED ON THE SITE IS SOLELY AT YOUR OWN RISK.

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    Sources: Our articles are written in part based on publicly available information, and our own practical experience relating to product compliance. These are some of the primary sources we use:

    • ec.europa.eu
    • echa.europa.eu
    • ecfr.gov
    • cpsc.gov
    • ftc.gov
    • fcc.gov
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