Moving towards safer alternatives

Compilation of criteria

You can use the list of organisations defining substances of concern to navigate to the desciription of used criteria.

1. Screening criteria for substances of very high concern (SVHC)

1.1 REACH Regulation Article 57

2. Criteria for screening substances of concern used by different organisations

Alternative assessment tools that include criteria for screening substances of concern:

2.1 Column Model, IFA (Germany)
2.2 Quick Scan, VROM (Netherlands)
2.3 PRIO, KEMI (Sweden)
2.4 Green Screen for Safer Chemicals version, Clean Production Action (Canada, US)
2.5 Design for the Environment Formulator Program – DfE, EPA (USA)
2.6 Five Chemicals alternatives assessment study, TURI (USA)
2.7 NTP 712 INSHT-National Institute for health and safety at work, (Spain)
2.8 Cradle to Cradle Design Protocol, MBDC (USA-Germany)

Other tools and lists that include criteria for screening substances of concern:

2.9 COSHH Essentials, Health and Safety Executive (UK)
2.10 MAL code system
2.11 National Plan to implement Stockholm Convention and Regulation 850/2004, on Persistent Organic Pollutants, Ministry of Environment (Spain)
2.12 SIN LIST, ChemSec (Sweden)
2.13 Trade Union List, European Trade Union Confederation (ETUC)
2.14 ISTAS Black list ISTAS (Spain)
2.15 SC Johnson Greenlist

1. Screening criteria for substances of very high concern (SVHC)

1.1 SOURCE: REACH Regulation Article 57

  1. Carcinogenic category 1 or 2 in accordance with Directive 67/548/EEC;
  2. Mutagenic category 1 or 2 in accordance with Directive 67/548/EEC;
  3. Toxic for reproduction category 1 or 2 in accordance with Directive 67/548/EEC;
  4. Substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation;
  5. Substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;
  6. Substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfill the criteria of points (d) or (e) – for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.

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2. Criteria for screening substances of concern used by different organizations

2.1 SOURCE: Column Model (CM), IFA Germany

Substances/preparations of very high risk:

-Acute health hazards:

  • Very toxic by inhalation R26/H330
  • Very toxic by skin contact R27/H310
  • Very toxic by swallowing R28/H300
  • Contact with acids liberates very toxic gas R32/EUH032

-Chronic health hazards:

  • Carcinogenic Category 1, K1(Germany), Category 2, K2(Germany), R45/H530, R49/H530i
  • Mutagenic Category 1 and 2 ,R46/H340
  • Combinations of R48 with risk phrases R23-25/H372

-Environmental hazards:

  • Warning symbol N and hazards indications R50 -59/H400, H410, H411, EUH059;
  • Water pollution classification WGK3 (Germany)

-Fire and explosion hazards:

  • Explosive R2,R3 / H200/ H201/H202/ H203/H204/H205
  • Extremely flammable gases and liquids R12/H220, H221, H224, H242
  • Spontaneously flammable R17/H250.

Substances/preparations of high risk:

-Acute health hazards:

  • Toxic substances/preparations R23 / H 330( vapours) or H331(gas, dust, mist) , R24/H311, R25/H301
  • Substances/preparations causing severe burns (highly corrosive) R35/H314
  • Substances/preparations which may liberate toxic gases when in contact with water or acids R29/EUH029, R31/EUH031
  • Skin sensitizing substances R43/H317
  • Substances sensitizing the respiratory tract R42/H334
  • Preparations containing skin or respiratory tract sensitizing substances in a concentra- tion ≥ 1% (in case of gases ≥ 0.2%)

-Chronic health hazards:

  • Substances toxic to reproduction of categories 1 or 2 R60/H360F, R61/H360D
  • Preparations containing substances toxic to reproduction of categories 1 or 2 in concen- trations ≥ 0.5% (in case of gases ≥ 0.2%)
  • Carcinogenic substances of category 3 R40/351, K3 (Germany)
  • Mutagenic substances of category 3 R68/H341, M3 ( Germany)
  • Preparations containing carcinogenic or mutagenic substances of category 3 in concentrations ≥ 1%
  • Substances which can accumulate in the human body R33/H373

-Fire and explosion hazards:

  • Highly flammable substances/preparations R11/H225 ( liquids and vapours)
  • Substances/preparations, liberating extremely flammable gases when in contact with water (R15)
  • Oxidizing substances/preparations R7/H242, R8/H270, R9/H271
  • Substances/preparations with specific properties R1, R4, R5, R6, R7, R14, R16, R18, R19, R30, R44/EUH001, EUH240, EUH006, EUH271, EUH014, EUH018, EUH019, EUH 209(A), EUH044

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2.2 SOURCE: Quick Scan (QS), VROM, Netherlands

Substances of very high concern (avoid):

  • PBT and vPvB
  • No data for p, B or T
  • Toxicity for humans:
    • Toxic: Danger of severe damage to health by prolonged exposure: R48/23, R48/24, R48/25 /H372.
    • Very toxic: danger of very serious irreversible effects through inhalation R26/H330, R39/26, /H370, in contact with skin R27/H310, R39/27 ,/ H370 or if swallowed R28/H300, R39/28, / H370
  • Carcinogenicity: May cause cancer R45/H350, R49/H350i, cat 1&2
  • Mutagenicity: May cause heritable genetic damage R46/H340
  • Limited evidence of carcinogenic effect R40/H351
  • Reprotoxicity: May impair fertility R60/H360F, may cause harm to the unborn child R61/H360D

Substances of high concern (not permitted in consumer applications and open professional use unless certain preconditions are satisfied):

  • PBT and vPvB
  • Toxicity for humans G2:
    • Toxic, or danger of very serious irreversible effects through inhalation R23/F330 -vapours or H331- gas, mist, dust, R39/23, /H370, in contact with skin R24/H311, R39/24,/H370 or if swallowed R25/H301, R39/25, /H370
    • May cause sensitization by skin contact R43/H317
    • May cause sensitization by inhalation R42/H334
    • Causes severe burns R34, R35/ H314
    • Contact with water or acids liberates very toxic gas R29/EUH029, R31EUH031, R32EUH032
    • Vapours may cause drowiness or dizziness R67/H336
  • Carcinogenicity: Limited evidence of carcinogenic effect R40/H351
  • Mutagenicity: May cause heritable genetic damage R46/H340
  • Reprotoxicity: Possible risk of impaired fertility R62/H361f, Possible risk of harm to the unborn child R63/H361d, may cause harm to breastfed babies R64/H362
  • Hormone disruption

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2.3 SOURCE: PRIO KEMI (PRI), Sweden

PHASE-OUT SUBSTANCES

  • Carcinogenic Category 1 and 2, R45/H350, R49/H350i
  • Mutagenic Category 1 and 2, R46/H340
  • Toxic to reproduction Category 1 and 2 : May impair fertility R60/H360F, May cause harm to the unborn child R61/H360D
  • Endocrine disrupter
  • Particularly hazardous metals (Cd, Hg, Pb)
  • PBT /vPvB – Persistent, Bioaccumulating, Toxic / very Persistent, very Bioaccumulating
  • Ozone-depleting substances R59/EUH059

PRIORITY RISK-REDUCTION SUBSTANCES

– Very high acute toxicity:

  • Very toxic by inhalation R26/H330
  • Very toxic by skin contact R27/H331
  • Very toxic by swallowing R28/H300
  • Very toxic: danger of very serious irreversible effects through inhalation R39/26, /H370
  • Very toxic: danger of very serious irreversible effects in contact with skin R39/27, /H370
  • Very toxic: danger of very serious irreversible effects if swallowed R39/28, H370

– High chronic toxicity:

  • Toxic: danger of serious damage to health by prolonged exposure through inhalation R48/23, /H327
  • Toxic: danger of serious damage to health by prolonged exposure in contact with skin R48/24 , /H327
  • Toxic: danger of serious damage to health by prolonged exposure if swallowed R48/25, /H327

-Allergenic:

  • May cause sensitisation by inhalation R42/H334, May cause sensitisation by skin contact High chronic toxicity R43/H317

-Mutagenic (Category 3):

  • Possible risk of irreversible effects R68 /H341

-Environmentally hazardous, long-term effects:

  • Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment R 50/53, / H400, H410
  • May cause long-term effects in the aquatic environment R53/H413
  • Potential PBT / vPvB

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2.4 SOURCE: Green Screen for Safer Chemicals (GS) vs 1: Evaluating Flame Retardants for TV Enclosures, Clean Production Action (CPA)

Substances to avoid —high concern:

  • PBT—high P + high B + high T (high human toxicity or high ecotoxicity); or
  • vPvB—very high P + very high B; or
  • vPT (vP + high T) or vBT
  • (vB + high T); or

High human toxicity for any priority effect:

  • Carcinogenicity
    • Evidence of adverse effects in humans;
    • Weight of evidence demonstrates potential for adverse effects in humans;
    • N TP known or reasonably anticipated to be human carcinogen;
    • OSHA carcinogen;
    • US EPA known/likely (probable);
    • California Prop 65;
    • IARC Group 1 or 2A;
    • EU Category 1 or 2; or
    • GHS Category 1A or 1B
  • Mutagenicity/ Genotoxicity
    • Evidence of adverse effects in humans;
    • Weight of evidence demonstrates potential for adverse effects in humans;
    • EU Category 1 or 2; or
    • GHS Category 1A or 1B
  • Reproductive toxicity
    • Evidence of adverse effects in humans;
    • Weight of evidence demonstrates potential for adverse effects in humans;
    • NTP Center for the Evaluation of Risks to Human Reproduction;
    • California Prop 65;
    • EU Category 1 or 2; or
    • GHS Category 1A or 1B
  • Developmental toxicity
    • Evidence of adverse effects in humans;
    • Weight of evidence demonstrates potential for adverse effects in humans;
    • NTP Center for the Evaluation of Risks to Human Reproduction; or
    • California Prop 65
  • Endocrine Disruption
    • Evidence of adverse effects in humans; or
    • Weight of evidence demonstrates potential for adverse effects in humans
  • Acute Toxicity (oral, dermal, or inhalation)
    • LD50
    • LD50
    • LC50
    • LC50
    • LC50
    • US EPA Extremely Hazardous Substance List; or
    • GHS Category 1 or 2
  • Corrosion/Irritation of the Skin or Eye
    • Evidence of irreversible effects in studies of human populations;
    • Weight of evidence of irreversible effects in animal studies; or
    • GHS Category 1 (skin or eye)
  • Sensitization of the Skin or Respiratory System
    • Evidence of adverse effects in humans;
    • Weight of evidence demonstrates potential for adverse effects in humans;
    • GHS Category 1—(skin or respiratory);or
    • Positive responses in predictive Human Repeat Insult Patch Tests (HRIPT) (skin)
  • Immune System Effects
    • Evidence of adverse effects in humans; or
    • Weight of evidence demonstrates potential for adverse effects in humans
  • Systemic Toxicity/Organ Effects (via single or repeated exposure)
    • Evidence of adverse effects in humans;
    • Weight of evidence demonstrates potential for adverse effects in humans;
    • GHS Category 1—organ/systemic toxicity following single or repeated exposure

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2.5 SOURCE: Design for the Environment Formulator (DfE) Program EPA, USA

DfE-recognized products do not contain components:

  • Classified under “Danger” following GHS
  • Pose a potential acute dermal toxicity hazard.
  • Known, probable or possible human carcinogens( IARC, NTP, USEPA, OSHA, scientific literature)
  • Ozone depleting compounds
  • Alkylphenoletoxilates (APEs)
  • Heavy metals
  • Phtalates
  • Inorganic phosphates
  • Fluorosurfactants

DfE-recognized products limit components:

  • Aquatic toxicity increases through long-term (chronic) exposure.
  • Potential to bioacumulate
  • Potential mutagens
  • Potential chronic health effects
  • VOCs, Hazardous Air Polutants, on EPA TRI
  • Reproductive toxicity
  • Respiratory and skin sensitizers
  • Severe skin and eye irritants

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2.6 SOURCE: Five Chemicals alternatives assessment study, Toxic Use Reduction Institute – TURI, USA

Alternatives screening criteria:

  • PBT: any two (P,B and/or T) estimated as high by PBT Profiler.
  • Known of probable human carcinogens: EPA group A or B, IARC 1 or 2A
  • TUR Science Advisory Board More Hazardous chemical list (38 substances)

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2.7 SOURCE: NTP712 (NT), National Institute for health and safety at work – INSHT, Spain

Priority chemicals to substitute:

  • carcinogens, mutagens, reprotoxicants-CMR: R40/H351; R45/H350; R49/H350i; R68/H341; R46/H340, R60/H360F, R61/H360D, R62/HH361f, R63/H361d, R64/H362
  • Sensitizers: R42/H334, R43/H317
  • Toxic and very toxic, persistent and bioacumulative: R23 -29; R31-33; R50 -59; R66-68 No specific R phrases for all substances
  • Endocrine disrupters: COM (1999)706. COM (2001)262 final.

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2.8 SOURCE: Cradle to Cradle (Cc) Design Protocol, MBDC, USA-Germany

Human Health Criteria

  • Carcinogenicity
  • Teratogenicity
  • Reproductive Toxicity
  • Mutagenicity
  • Endocrine Disruption 0
  • Acute Toxicity
  • Chronic Toxicity
  • Irritation of Skin/Mucous Membranes
  • Sensitization
  • Carrier Function or Other Relevant Data

Environmental Relevance Criteria

  • Algae Toxicity
  • Bioaccumulation (log Kow)
  • Climatic Relevance/Ozone Depletion Potential
  • Content of Halogenated Organic Compounds (AOX)
  • Daphnia Toxicity
  • Fish Toxicity
  • Heavy Metal Content
  • Persistence/Biodegradation
  • Toxicity to Soil Organisms (Bacteria and Worms)

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2.9 SOURCE: COSHH Essentials (CS), Health and Safety Executive, UK

Substances to avoid:

Extremely toxic substances: R45/ H350, R46/H340, R49/H350i, R42/H334, R42/43/H317, R68/H341

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2.10 SOURCE: Danish MAL code system

Can be used to prioritize substances and products according to risk.

  • Risk due to inhalation

Is reflected by the number before the hyphen that divides substances and products in seven groups (from 00 to 5) according to the risk due to inhalation.

  • Risk due to exposure : inhalation of drops/dust, contact with skin and/or eyes, ingestion

Is reflected by the number after the hyphen and defines seven groups ( from 0 to 6)

0. No harmful effect

1. Inhalation of spray clouds

2. Ingestion or inhalation of spray clouds

3. Skin or eye contact Allergy

4. Caustic burns

5. Allergy on skin contact. Particular risk to health on skin and eye contact

6. Toxic on skin and eye contact. Long-term effects, e.g. cancer

Go to: source (Executive Order 301/1993, Executive order 302/1993) or archived document (301/1993, 302/1993)

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2.11 SOURCE: National Plan to implement Stockholm Convention and Regulation 850/2004, on Persistent Organic Pollutants, Ministry of Environment, Spain

Criteria for POP substitution:

  • Avoiding POP forerunners.
  • Avoiding substances and products with similar characteristics to those of POP’s according to selection criteria of Annex D of the Stockholm Convention: Persistence, Bioaccumulation, capability of long distance release into the environment and adverse effects.
  • Avoiding substances and compounds with carcinogen, mutagenic, disrupting, toxic, neurotoxic and sensitizing effects, or any other substances with similar levels of concern

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2.12 SOURCE: SIN LIST, ChemSec, Sweden

  • Substances that are Carcinogenic, Mutagenic, and toxic to Reproduction (CMR) 1A and 1B following Regulation 1272/2008 on Classification, Labelling and Packaging (CLP)
  • Substances that are Persistent, Bioaccumulative and Toxic or very Persistent and very Bioaccumulative (PBTs and vPvBs) following European Union PBT Working Group list.
  • Substances of Equivalent level of Concern:
    • Endocrine disrupting chemicals (EDCs) assessed to be of high or medium concern (58 substances) from a European Commission report on EDCs (COM (2001/262).
    • Chemicals that are persistent or bioaccumulate, but do not indicate high levels of toxicity (P and B, but not T).

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2.13 SOURCE: Trade Union List, European Trade Union Confederation – ETUC

Carcinogenic substances:

  • Substances classified as category 1A, 1B and 2 in accordance with EU Regulation 1272/2008.
  • Substances classified by the International Agency for Research on Cancer (IARC) as human carcinogens (IARC 1), that are probable human carcinogens (IARC 2A) and that are possible human carcinogens (IARC 2B).

Mutagenic substances:

  • Substances classified as mutagenic category 1A, 1B and 2 in accordance with CLP Regulation (categories 1, 2 and 3 in accordance with Directive 67/548/EEC).

Toxic for reproduction:

  • Substances classified as toxic for reproduction category 1A, 1B or 2 in accordance with CLP Regulation (categories 1, 2 and 3 in accordance with Directive 67/548/EEC).

PBT/vPvB:

  • PBT list of the OSPAR Convention for the Protection of the Marine Environment of the North-East Atlantic.
  • PBT/vPvB list of the Technical Committee on New and Existing Substances (TCNES).

EDC:

  • Substances included in the priority list developed within the EU-Strategy for Endocrine Disrupters classified as category 1 and category 2.

Neurotoxicants:

  • Provisional list for occupational neuro – toxicants included in the review published by Vela et al.

Sensitizers:

  • Substances classified as skin or respiratory sensitizers by CLP Regulation, (H334 and H317).
  • Substances included in the “List of REACH Allergens”

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2.14 SOURCE: ISTAS Black list – Instituto Sindical de Trabajo Ambiente y Salud – ISTAS, Spain

Substances to avoid:

  • Acute toxicity:
    • Very toxic R26/H330, R27/H310, R28/H300 and combinations: R26/27, R26/28, R26/27/28, R27/28
    • Contact with acids liberates very toxic gas R32/EUH032
  • Chronic toxicity:
    • Carcinogens: Category 1,2&3 UE (R40/H351, R45/H350, R49/H350i), and IARC groups 1, 2A and 2B
    • Mutagens: Category 1,2 & 3,R46/H350i, R68/H341
    • Toxic for reproduction: Category 1,2 & 3 -R60/H360F, R61/H360D, R62H361f, R63/H361d
  • High chronic toxicity: R48/23, R48/24 , R48/25, R48/23/24, R48/23/25, R48/24/25, R48/23/24/25, / H372
  • Severe irreversible effects: T+ R39/26,T+ R39/27, T+ R39/28, T+ R39/26/27, T+ R39/26/28, T+ R39/27/28, T+ R39/26/27/28, / H370
  • Endocrine disrupters: EU lists of known endocrine disrupters COM (1999)706, COM (2001)262, SEC (2004)1372 and SEC (2007)1635.
  • Permanent neurotoxic effects
  • Sensitizers
  • Environmental hazards:
    • Symbol N and some phrase between R50, R51, R53, R54, R55, R56, R57, R58 o R59
    • WGK3
    • PBT
  • Fire and explosion hazards:
    • Explosive R2,R3/ H200/ H201/H202/ H203/H204/H205
    • Extremely flammable gases and liquids R12/H220, H221, H224, H242
    • Spontaneously flammable R17/H250

Go to: source (Spanish)

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2.15 SOURCE: SC Johnson Greenlist

Restricted Use Material (RUM) considers.

  • Aquatic toxicity
  • Ultimate biodegradability
  • EU Environmental classification
  • Acute human toxicity
  • Source/supplier
  • “Other significant concerns”:
    • Future EPA* Classifications
    • Other chemicals concern lists
    • Banned in 1+ countries (Top 22)
    • Unofficial ban (trade/associations)
    • Endocrine Disruptor
    • Reproductive Toxicity (Proposal 65)
    • Carcinogenicity (Proposal 65 IARC)

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