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Substance group

What counts as Primary aromatic amines (REACH entry…?

Only European Union defines Primary aromatic amines (REACH entry 43) in its law. Read the definition below. You tell us if your product contains it; we never guess from its name.

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Group

Definitions

Market
Definition
Listed members
Source
Primary aromatic amines listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 for which Annex I of Regulation 10/2011 specifies no migration limit
4-Aminobiphenyl (4-aminodiphenyl), Benzidine [and its salts], p-Chloro-o-toluidine, 2-Naphthylamine, o-Aminoazotoluene, 5-Nitro-o-toluidine, p-Chloroaniline, 2,4-Diaminoanisole, 4,4'-Methylenedianiline, 3,3'-Dichlorobenzidine, 3,3'-Dimethoxybenzidine (o-Dianisidine), 3,3'-Dimethylbenzidine (ortho-Tolidine), 4,4'-Methylene bis(2-methylaniline), p-Cresidine, 4,4'-Methylene bis(2-chloroaniline), 4,4'-Diaminodiphenyl ether (4,4'-Oxydianiline), 4,4'-Thiodianiline, o-Toluidine, 2,4-Diaminotoluene, 2,4,5-Trimethylaniline, o-Anisidine, p-Aminoazobenzene
“Primary aromatic amines (‘PAAs’) listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (10) and for which no migration limit is specified in Table 1 of Annex I”
Annex II point 2 (excerpt) · fetched 2026-10-08European Commission / EUR-Lex: Annex II point 2(opens in a new tab)
  • Definition
    Primary aromatic amines listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 for which Annex I of Regulation 10/2011 specifies no migration limit
    Listed members
    4-Aminobiphenyl (4-aminodiphenyl), Benzidine [and its salts], p-Chloro-o-toluidine, 2-Naphthylamine, o-Aminoazotoluene, 5-Nitro-o-toluidine, p-Chloroaniline, 2,4-Diaminoanisole, 4,4'-Methylenedianiline, 3,3'-Dichlorobenzidine, 3,3'-Dimethoxybenzidine (o-Dianisidine), 3,3'-Dimethylbenzidine (ortho-Tolidine), 4,4'-Methylene bis(2-methylaniline), p-Cresidine, 4,4'-Methylene bis(2-chloroaniline), 4,4'-Diaminodiphenyl ether (4,4'-Oxydianiline), 4,4'-Thiodianiline, o-Toluidine, 2,4-Diaminotoluene, 2,4,5-Trimethylaniline, o-Anisidine, p-Aminoazobenzene
    Source
    “Primary aromatic amines (‘PAAs’) listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (10) and for which no migration limit is specified in Table 1 of Annex I”
    Annex II point 2 (excerpt) · fetched 2026-10-08European Commission / EUR-Lex: Annex II point 2(opens in a new tab)

Rules

The rule that uses this definition

1 rule.

Requirement
Applies when
Effective
Source
LimitEU
Primary aromatic amines (REACH entry 43) as defined in European Union

Limit 0 mg/kg (migration basis)

ND (not detectable): limit of detection 0,002 mg/kg food or food simulant for each individual amine, per Art. 11(4) and Annex II point 2: "They shall not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg"

Consolidated text (not the authentic legal edition), current to 14 Jul 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02011R0010-20260714 from the Publications Office, the latest when read.

  • Food-contact product
  • Material: Plastic (type not stated) or Melamine resin

Depends on: whether the product touches food, materials

In force since 3 Sep 2020

Applies to products placed on the market on or after 3 Sep 2020

Annex II is marked M15 (Regulation (EU) 2020/1245, OJ 3.9.2020). The consolidated text states no application date; the OJ date, the earliest possible, is used. The original 2011 Annex II had a single 0,01 mg/kg sum limit for all PAAs outside Table 1; the per-amine 0,002 mg/kg detection limit is new in M15.

“They shall not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg food or food simulant applied to each individual primary aromatic amine”
Annex II point 2 (excerpt) · fetched 2026-10-08European Commission / EUR-Lex: Regulation (EU) No 10/2011(opens in a new tab)
  • LimitEU
    Primary aromatic amines (REACH entry 43) as defined in European Union

    Limit 0 mg/kg (migration basis)

    ND (not detectable): limit of detection 0,002 mg/kg food or food simulant for each individual amine, per Art. 11(4) and Annex II point 2: "They shall not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg"

    Consolidated text (not the authentic legal edition), current to 14 Jul 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02011R0010-20260714 from the Publications Office, the latest when read.

    Applies when
    • Food-contact product
    • Material: Plastic (type not stated) or Melamine resin

    Depends on: whether the product touches food, materials

    Effective

    In force since 3 Sep 2020

    Applies to products placed on the market on or after 3 Sep 2020

    Annex II is marked M15 (Regulation (EU) 2020/1245, OJ 3.9.2020). The consolidated text states no application date; the OJ date, the earliest possible, is used. The original 2011 Annex II had a single 0,01 mg/kg sum limit for all PAAs outside Table 1; the per-amine 0,002 mg/kg detection limit is new in M15.

    Source
    “They shall not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg food or food simulant applied to each individual primary aromatic amine”
    Annex II point 2 (excerpt) · fetched 2026-10-08European Commission / EUR-Lex: Regulation (EU) No 10/2011(opens in a new tab)

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