Regulatory Insights – ECHA Provides Clarification on PNEC/ DNEL Derivation and Risk Assessments

Regulatory guidance

Chemicals

ECHA Provides Clarification on PNEC/ DNEL Derivation and Risk Assessments

Date: 23 March 2022

On behalf of our clients, we asked ECHA to comment on the necessity of PNEC/ DNEL derivation and risk assessments in four specific cases. We have summarised the cases and answers from ECHA for you in the table attached. If you have any queries, please do not hesitate to contact us.

1	2	3	4	5	6	7	8	9

Ziram 91/414 list 1 FU,RE Other	Approved	2022-04-30		AIR 3 G2 B4	Yes - two PBT criteria	Not assessed	2:2003/81 3:2021/566 3:2020/421 3:2019/168 3:2016/2016 3:2012/1197
Zoxamide 91/414 New FU Other	Approved	2033-06-30		AIR 3 G1 B3	No	No	2:2003/119 3:2018/692 3:2018/84 3:2016/2016 3:2012/823
Zucchini yellow mosaic virus (ZYMV mild strain) 1107/2009 New FU Other	Not approved				No	Not assessed		Application withdrawn.
Zucchini Yellow Mosaik Virus, weak strain 1107/2009 New EL Other	Approved	2023-05-31			No	No	2:2012/1237
Substance name Existing / New a.s. Category (fungicide, herbicide etc.) Type (basic / low risk / other)	Approval status	Expiry of inclusion	Withdrawal date (non inclusion)	1107/2009 (AIR)	CfS	Cut off	Legislation (by column number)	Specific remarks

Substance name

Category (fungicide, herbicide etc.)

Type (basic / low risk / other)

Approval status

Expiry of
inclusion

Withdrawal date
(non inclusion)

1107/2009
(AIR)

CfS

Cut off

Legislation
(by column number)

Specific remarks

Ziram

91/414 list 1

FU,RE

Other

Approved

2022-04-30

AIR 3 G2 B4

Yes - two PBT criteria

Not assessed

Zoxamide

91/414 New

Other

Approved

2033-06-30

AIR 3 G1 B3

Zucchini yellow mosaic virus (ZYMV mild strain)

1107/2009 New

Other

Not approved

Not assessed

Application withdrawn.

Zucchini Yellow Mosaik Virus, weak strain

1107/2009 New

Other

Approved

2023-05-31

2:2012/1237

Substance name

Existing / New a.s.

Category (fungicide, herbicide etc.)

Type (basic / low risk / other)

Approval status

Expiry of
inclusion

Withdrawal date
(non inclusion)

1107/2009
(AIR)

CfS

Cut off

Legislation
(by column number)

Specific remarks

1	2	3	4	5	6	7	8	9
Substance name Category (fungicide, herbicide etc.) Type (basic / low risk / other)	Approval status	Expiry of inclusion	Withdrawal date (non inclusion)	1107/2009 (AIR)	CfS	Cut off	Legislation (by column number)	Specific remarks

Ziram 91/414 list 1 FU,RE Other	Approved	2022-04-30		AIR 3 G2 B4	Yes - two PBT criteria	Not assessed	2:2003/81 3:2021/566 3:2020/421 3:2019/168 3:2016/2016 3:2012/1197
Zoxamide 91/414 New FU Other	Approved	2033-06-30		AIR 3 G1 B3	No	No	2:2003/119 3:2018/692 3:2018/84 3:2016/2016 3:2012/823
Zucchini yellow mosaic virus (ZYMV mild strain) 1107/2009 New FU Other	Not approved				No	Not assessed		Application withdrawn.
Zucchini Yellow Mosaik Virus, weak strain 1107/2009 New EL Other	Approved	2023-05-31			No	No	2:2012/1237
Substance name Existing / New a.s. Category (fungicide, herbicide etc.) Type (basic / low risk / other)	Approval status	Expiry of inclusion	Withdrawal date (non inclusion)	1107/2009 (AIR)	CfS	Cut off	Legislation (by column number)	Specific remarks

Regulatory Guidance

Chemicals

ECHA Provides Clarification on PNEC/ DNEL Derivation and Risk Assessments

Date: 23 March 2022

Ramboll Deutschland GmbH

Office Bad Kreuznach

Ramboll Japan

Office Berlin