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Table 2 Criteria to identify candidates for substitution

From: The implementation of the substitution principle in European chemical legislation: a comparative analysis

Criteria

PPPR (Art 24, Annex II)

BPR (Art 10)

REACH (Art 57)

Mutagen Class 1A or 1Ba

Cannot be authorised

b

Carcinogen Class 1A or 1Ba

c

Toxic for reproduction Class 1A or 1Ba

c

b

Endocrine disrupting propertiesd

c

b

Lower ADI, ARfD or AOEL than the majority of approved substancese

In the same group of substance/use category

In the same product-type and use scenario

Not applied

Persistent, Bioaccumulative and Toxic (PBT)f

2 of 3 criteria

2 of 3 criteria

3 of 3 criteria

Very Persistent, very Bioaccumulative (vPvB)f

Not applied

b

Respiratory sensitiser propertiesg

Not applied

Significant proportion of non-active isomers or impurities

h

Not applied

Other concerns associated with critical effects in combination with use/exposure patterns, in particular risks to groundwater

Not applied

Equivalent level of concern linked to probable serious effects to human health or the environmentd

Not applied

Not applied

  1. aAccording to Regulation (EC) No. 1272/2008
  2. bSubstances with those properties can only be authorised as a biocide if risk is negligible, the substance is essential to prevent or control a serious danger or if not approving the substance would have a disproportionate negative impact on society (Art 10 and 5(2) of Regulation 528/2012)
  3. cSubstances with those properties can only be authorised as a pesticide if exposure is negligible and residue levels do not exceed the default according to Regulation 396/2005, Art 18(1b) (Annex II Point 4 of Regulation 1107/2009)
  4. dPesticides: according to Regulation 2018/605; biocides: according to Regulation 2017/2100; industrial chemicals: according to Art 57(f) and Art 59 of Regulation 1907/2006
  5. eADI—Acceptable Daily Intake, ARfD—Acute Reference Dose, AOEL—Acceptable Operator Exposure Level
  6. fPesticides: according to Regulation 1107/2009, Annex II, Point 3.7.2., Biocides: according to Regulation (EC) 253/2011, Industrial chemicals: according to Regulation (EC) 253/2011
  7. gAccording to Regulation (EC) No. 1272/2008
  8. hRegulation 1107/2009 (PPPR) only considers the proportion of non-active isomers