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EU Candidate for Substitution (CfS) Authoritative Interpretation and Latest List Update
2022/10/20 14:21:32


EU Candidate for Substitution (CfS) Authoritative Interpretation and Latest List Update


EU Candidate for Substitution (CfS) Judgment Standards and Interpretation.

According to the EU pesticide regulations (EC) NO 1107/2009, an active substance shall be approved as a candidate for substitution (CfS) where any of the following conditions are met:

1. Its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances within groups of substances/use categories.

Interpretation: ADI, ARfD and AOEL are the values of the amount of harm of reactive active substances (related to toxicity). The smaller these values indicate that the harm of the corresponding active substance is greater.

Therefore, if there are two active substances, A and B, which can both be used to control a certain crop disease, but the ADI of A is less than that of B, then A is more likely to be judged as CfS in this case.

 

2. It meets two of the criteria to be considered as a PBT substance.

Interpretation: PBT corresponds to persistence, bioaccumulation and toxicity, respectively.

According to the EU pesticide regulation, an active substance is not allowed to be registered if it meets all three criteria of a PBT substance. However, if the active substance meets any two of the three criteria for a PBT substance, then the active substance is allowed to register, but it will be judged as a CfS.

 

3. There are reasons for concern linked to the nature of the critical effects (such as developmental neurotoxic or immunotoxic effects) which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, for example, high potential of risk to groundwater; even with very restrictive risk management measures (such as extensive personal protective equipment or very large buffer zones).

Interpretation: This condition is a supplement to the hazard assessment and exposure assessment of active substances that may be judged to be CfS. 

In addition to the data requirements of conventional toxicity nodes, it is also necessary to focus on the developmental neurotoxicity and immunotoxic effects of active substances in hazard assessment. Currently, the European Union is considering whether to add new hazard classification requirements for these two toxicity nodes. Scenarios that pose potential exposure to humans, such as groundwater contamination by active substances, also require high attention in exposure assessments.

In addition, an active substance may be classified as a CfS if the risk of an active substance is acceptable only after taking risk reduction measures that are difficult to achieve.

 

4. It contains a significant proportion of non-active isomers.

Interpretation: For example, S-metolachlor has removed the low-activity isomer of Metolachlor, so Metolachlor will be judged as a CfS and has even been deregistered by the European Union.


5. Although the applicant can prove that the exposure of this active substance to the human body can be ignored, according to EU regulations (EC) NO 1272/2008, as carcinogen category 1A or 1B.


6. Although the applicant can prove that the exposure of this active substance to the human body can be ignored, according to EU regulations (EC) NO 1272/2008, as toxic for reproduction category 1A or 1B.

Interpretation: If any of the carcinogenic, mutagenic, and toxic to reproduction categories of an active substance are classified as class 1A or 1B, unless the applicant can demonstrate that the exposure to human body is negligible, then the active substance is not allowed to be registered.

However, if the applicant can provide that the active substance has negligible exposure to humans, then the active substance is allowed to register, but it will be judged as a CfS.


7. Although the applicant can prove that the exposure of this active substance to the human body can be ignored, however, the active substance has been identified as an endocrine disruptor based on adequate evaluation.

Interpretation:If an active substance is identified as an endocrine disruptor in accordance with the European Union guidance for the identification of endocrine disruptors published in 2018, it will not be allowed to be registered unless the applicant can demonstrate that the exposure of the active substance to humans is negligible.

However, if the applicant can provide that the active substance has negligible exposure to humans, then the active substance is allowed to register, but it will be judged as a CfS.

At the current stage, the European Union is also considering adding new requirements for the classification of endocrine disruptors (which have effects on both human health and the environment).

 

The List of EU Candidate for Substitution (CfS) Update.

In 2015, substances approved under Regulation 91/414/EEC (full name Council Directive 91/414/EEC, the predecessor of the EU 1107 regulations) and meeting these criteria were included in the list of candidate for substitution (CfS) (full name Commission Implementing Regulation (EU) 2015/408 Annex) based on these criteria. The list was first published in March 2015 and a material amendment was carried out every 1-2 years.

The recent amendment was in August and is now in force in all EU member states. In this amendment, some substances that are no longer in the approved status in the CfS list (Commission Implementing Regulation (EU) 2015/408 Annex) and substances that have been included in the 540 list (COMMISSION IMPLEMENTING REGULATION (EU) No 540/2011 PART E) after re-evaluation are removed from the official list.

 

Included in the 540 list from CfS list can be divided into two cases:

CASE 1

After re-evaluation, substances in the CfS List will be removed from the CfS list if they are included in 540 list as general active substances. For example: Quizalofop-P, etc.

Take Quizalofop-P as an example. Quizalofop-P is an active substance that has been approved in the European Union. The previous European Union was classified as reproductive toxicity category 1B, so it was included in the CfS list.

In 2018, the European Commission classified it into reproductive toxicity category 2. After the classification is updated, the Quizalofop-P no longer meets the selection criteria for candidate for substitution. After the re-evaluation, Quizalofop-P is included in the 540 list as a general active substance. Therefore, the Quizalofop-P is removed from the CfS list in this amendment.

 

CASE 2

After re-evaluation, if the substance in the CfS list is still included in the 540 list as the CfS, it will also be removed from the CfS list. But in this case, the substances are still CfS, just on a different list. For example, Metsulfuron-methyl, Lambda-cyhalothrin, Imazamox, etc.

 

The following substances were removed from the CfS list in this amendment:

Substances

Reason for deletion (material state)

Amitrole, Bifenthrin, Bromadiolone, Carbendazim, Carbetamide, Cyproconazole, Difenacoum, Dimethoate, Diquat, Epoxiconazole, Ethoprophos, Famoxadone, Fenamiphos, Fenbutatin Oxide, Fipronil, Fluquinconazole, Glufosinate, Haloxyfop-P (including Haloxyfop-P-methyl), Imazosulfuron, Isoproturon, Isopyrazam, Linuron, Lufenuron, Mecoprop, Methomyl, Molinate, Myclobutanil, Oxadiargyl, Oxadiazon, Prochloraz, Profoxydim, Propiconazole, Quinoxyfen, Tepraloxydim, Thiacloprid, Triasulfuron, Triazoxide, Warfarin

Banned

Copper compounds, Esfenvalerate, Etoxazole, Imazamox, Lambda-cyhalothrin, Metsulfuron-methyl, Pendimethalin, Prosulfuron

540 list (CfS)

Quizalofop-P (Variant Quizalofop-P-Tefuryl)

540 list (general   active substance)

 

Source from REACH 24H.

 

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