Health and Safety Executive ( HSE)  
1  REGULATION No 1107/2009  
DECISION TO WITHDRAW  APPROVAL OF THE ACTIVE SUBSTANCE  
MANCOZEB  IN GB  
DRAFT  
 
Issue  
 
This report sets out the decision to withdraw approval of the active substance 
mancozeb in Great Britain (GB).  It explains the process for reviewing the approval 
and the reasons for the decision.  It summarises the information relevant to the 
decision and  the grace periods that apply.  
 
 
Background  
 
Mancozeb  is a fungicidal  active substance used in plant protection products, which 
are regulated under retained Regulation (EC) No 1107/2009  (“the Regulation”) .  The 
Regulation requires that active substances must  be approved for such use .  
Approval is given if, in the light of current scientific and technical knowledge, 
authorisation of a plant protection product is expected to be possible for at least one 
representa tive us e. 
 
 
Regulatory process  
 
On 14 December 2020 the E uropean  Commission decided not to renew the approval 
of mancozeb in the European Union ( EU) and Northern Ireland.  Although t his 
decision had no legal effect in GB , the approval criteria in GB are the same as in the 
EU.  In the light of new scientific and technical knowledge, HSE considered that this 
decision indicated that mancozeb may no longer satisfy the criteria for approval in 
the Regulation.   Therefore,  on 23 July 2021 HSE proposed a review o f the GB 
approval of mancozeb under Article 21(1) of the Regulation .  The proposed review 
would examine the endocrine disrupting potential of mancozeb and the non -dietary 
risks to human health (ie Annex II, paragraph 3.6.5 and Art. 4(3)(b) of the 
Regulatio n).  In accordance with the agency agreements which delegate work under 
the Regulation to HSE, t he GB competent authorities gave their consent to this 
review in July 2021 .  
 
At the time of the initiation of the review , four companies held authorisations for 
mancozeb -containing products in the UK  and were considered producers .  These 
were  UPL Europe Ltd, Indofil Industries (Netherlands) BV ( together, UPL and Indofil 
form the EU Mancozeb Task Force (EU MTF )), Agria  SA, and Corteva Agriscience 
UK Limited.  On 2 September 2021 , HSE informed these  producers  of the initiation 
of the  review  and the reasons for it.  They  were  given one month t o submit 
comment s for consideration as part of the review.   A summary of t he 
comments /responses  received are included in Annex I  of this document .  Note that Health and Safety Executive ( HSE)  
2  BASF w as a major producer, but chose to withdraw production, and consequently  
the GB products, shortly after the EU non -renewal decision . 
 
Following the submission of comments,  HSE undertook  an independent, objective, 
assessment of mancozeb in light of current scientific and technical knowledge .  This 
included a review of  the scientific evidence that supported the EU non -renewal  
decision  and the comments received from the producers .  HSE concluded that 
mancozeb failed to meet the approval criteria and so  approval  should be withdrawn 
in GB .  A summary of HSE’s scientific review is at Annex II. 
 
HSE concluded that the failure to meet approv al criteria as regards endocrine 
disrupting potential and non -dietary risks to human health was s ufficiently  clear cut 
that it was unnecessary to obtain independent scientific advice.  Moreover, a detailed 
assessment of any further  criteria was unnecessary  given the concerns identified .   
 
In accordance with the agency agreements, HSE notified the GB competent 
authorities of its decision that approval of mancozeb should be withdrawn, the 
reasons for that decision , and the details of the grace period it prop osed to set.   GB 
Administration s gave their consent to HSE carrying out the decision -making function 
in this case  and HSE notified the producers of the decision, the reasons for it and the 
grace period set on [ dd mm yyyy ]. 
 
 
Decision  
 
HSE has decided that approval of mancozeb  for use in plant protection products  
should be withdrawn  in GB.    
 
The decision reflects the overall conclusion from the assessment and consideration 
of the scope to manage the risks arising from use of plant protection p roducts 
containing this active substance.  
 
Consequently, p lant protection products containing mancozeb can  no longer  be 
authorised in in GB and existing authorisations must be withdrawn in accordance 
with the requirements of the Regulation.  
 
 
Statement of reasons  
 
The reasons for the decision to withdraw mancozeb in GB are that : 
 
- it meets the criteria to be classified as having endocrine disrupting properties 
for humans and non -target organisms according to the T (thyroid) modality;  
- non-dietary exposure exceeds the reference  Acceptable Operator Exposure 
Level / Acute Acceptable Operator Exposure Level (AOEL/AAOEL) . 
 
 
Grace period  
 Health and Safety Executive ( HSE)  
3  In accordance with Art. 21(7)  of the Regulation, authorisations  of existing products 
should be phased out so that:  
 
- advertisement, sale and supply of each product are allowed until dd mm yyyy ;  
- storage, disposal and use are allowed until dd mm yyyy . 
 
 
 
Further  information  
 
The GB Approvals register will be updated to reflect this decision.   
 
 
 
 
 
 
 
[date]  
 
  Health and Safety Executive ( HSE)  
4  Annex I –  List of information submitted in response to GB Article 21 review,  
with brief HSE action  
 
Commenting company  Date  Comments received  
EU Mancozeb Task Force 
(UPL Europe Ltd and 
Indofil Industries 
(Netherlands)  BV): 29 September 2021  Reference made to the 
supplementary dossier 
submitted to GB in support 
of the renewal of mancozeb 
with particular attention 
drawn to the sections on ED 
and non -dietary human 
health. This information has 
been taken into account in 
the GB assessment.  
Fieldfisher on behalf of 
Agria SA  30 September 2021  Reference made to the 
additional information 
provided by Agria in their 
submission that was 
considered by Greece as 
part of a consideration for 
an updated  Renewal 
Assessment Report  (RAR ). 
Particular atten tion was 
drawn to the ED aspects, 
Toxicological Reference 
Values and non -dietary 
exposure, the risk to birds 
and mammals, and the risk 
to non -target arthropods and 
soil macro -organisms.  
 
As detailed in Annex II, 
Greece would not share this 
assessment with  GB and 
neither Fieldfisher or Agria 
responded to requests for 
further detail relating to this 
information.  
 
Where possible the detail 
provided by Fieldfisher in 
their original comment was 
taken into account as part of 
the GB assessment.  
Corteva Agriscience UK 
Limited  20 September 2021  Review was acknowledged 
but no technical comments 
supplied  
 
 
  Health and Safety Executive ( HSE)  
5  Annex I I – Summary Assessment by HSE Supporting the Recommendation  
 
The HSE  review took account of the information that supported the EU decision to 
non-renew approval of m ancozeb.  As requested in the comments from the EU MTF , 
HSE also considered the information that was provided in support of the application 
for the renewal in GB of mancozeb under Article 14 of the Regulation.  As requested 
in the comments from FieldFisher on behalf of Agria SA , HSE contacted the Greek 
authority to request a copy of their assessment.  After consulting with the EU 
Commission, the Greek authority advised that they would not provide HSE with the 
document.  In response , HSE sent a number of requests to FieldFisher and Agria SA 
asking  that they provide the assessment direct  to HSE , otherwise it would not be 
considered  in the review.  HSE did not recei ve a response .  The further comments 
from FieldFisher on behalf of Agria SA were taken into account . 
 
Toxicology  (Human Health)  
 
Two critical areas of concern were identified in the EFSA Conclusion for mancozeb:  
 
- Classification as toxic for reproduction category 1B ( Repr.1B ) under 
Regulation  1272/2008 (RAC Opinion, 2019);  
- Meeting the criteria to be classified as having endocrine disrupting properties 
for humans according to the T (thyroid) modality . 
These are two hazard -based cut -off criteria for approval.  Negligible exposure could 
not be demonstrated as the non -dietary exposure exceeded the reference values.  In 
addition, due to the other safety concerns identified, a derogation under Art 4(7) of 
1107/2009 was not applicable.  
 
With regard to classification as Repr 1B, HSE Toxicology has considered the RAC 
Opinion and developed its own GB -specific position which is documented in a 
Technical Report published on HSE website .  In this report, HSE disagrees with RAC 
and concludes that Repr.2 is the most appropriate classification for mancozeb based 
on the available evidence.  Classification as Repr.2 is not an exclusion criterion for 
approval/renewal.  
 
With regard to mancozeb meeting the criteria for being a thyroid endocrine disruptor 
(ED) for humans, HSE ’s toxicology  assessment reach es the same conclusion as in  
the EU  assessment  (whose own conclusion  was originally proposed by the UK when 
acting as rapporteur Member State for the renewal of mancozeb in the EU ). 
Mancozeb is a potent ED, with effects occurring in experimental animals fr om 
approx. 6 mg/kg bw/d.  
 
Overall, having carefully considered the  information that was considered as part of 
the EU evaluation of  the toxicology of mancozeb  and taking account of the 
comments received  under this review , HSE has concluded  that the ED exclu sion 
criterion of the Regulation  has been met  and that regulatory action  is warranted . 
 
 
 
 Health and Safety Executive ( HSE)  
6  Non-dietary Exposure  
 
The EU Renewal was supported by three  representative products:  
 
• Penncozeb 80 WP  (also supported in the application submitted for GB 
renewal of approval)  
• Dithane M -45 (also supported in the application submitted for GB renewal of 
approval)  
• Mancozeb 800 WP  
All three  products are wettable powders (WP) containing 805 g/kg, 800 g/kg and 8 05 
g/kg mancozeb , respectively.  The representative uses evaluated for Penncozeb 80 
WP and Dithane M -45 were as a fungicide applied as a foliar spray on wheat, potato 
and grapes, with the same application rates and timings for both products.  The 
represent ative uses for ‘Mancozeb 800 WP’ was as a fungicide applied to protected 
tomatoes grown in greenhouses.   HSE has  considered the information supporting 
the EU decision as well as looking at the information provided in support of the GB 
renewal application a s part of this review.  
 
The HSE  assessment reaches the same conclusion as the EU evaluation in which 
the acceptable operator exposure level (AOEL) for mancozeb was as set at 0.011 
mg/kg bw/day, with an acute acceptable operator exposure level (AAOEL) of 0. 075 
mg/kg bw/day.  Exposure was also assessed for  ethylene thiourea  (ETU), a major 
metabolite of mancozeb which is formed when a formulation of mancozeb is 
dissolved in solution (i.e. ETU is present in the in -use concentration of the spray 
solution).  The AOEL of ETU was set at 0.002 mg/kg b w/day and the AAOEL at 0.01 
mg/kg bw/day.  Dermal absorption values for the 3 representative formulations were 
0.7% for the concentrate products and 1% for the spray dilutions.  
 
For application of Penncozeb 80 WP/ Dithane M -45 to wheat , unacceptable exposure 
above the AOEL/AAOEL for mancozeb was estimated for operators with the use of 
PPE, and also for residents.  Combined exposure for mancozeb and ETU was 
estimated to be above acceptable levels for operators and re sidents.  
 
For application of Penncozeb 80 WP/Dithane M -45 to potatoes , unacceptable 
exposure above the AOEL/AAOEL for mancozeb was estimated for operators with 
the use of PPE, and also for residents.  Combined exposure for mancozeb and ETU 
was estimated to  be above acceptable levels for operators, residents and workers.  
 
For application of Penncozeb 80 WP/Dithane M -45 to grapes , unacceptable 
exposure above the AOEL/AAOEL for mancozeb was estimated for operators with 
the use of PPE and a closed cabin tractor , and also for residents.  Combined 
exposure for mancozeb and ETU was estimated to be above acceptable levels for 
operators and residents.  
 
For application of Mancozeb 800 WP to protected tomatoes , unacceptable exposure 
above the AOEL for mancozeb was estimated for workers with the use of gloves.  No 
data were provided to determine the level of ETU in the spray solution for Mancozeb 
800 WP ; therefore,  it was not possible to conduct a non -dietary exp osure Health and Safety Executive ( HSE)  
7  assessment for ETU or a combined exposure assessment of mancozeb and ETU for 
the proposed use of Mancozeb 800 WP on protected tomatoes.  This was reported 
as a data gap in the EFSA Conclusion and the issue not finalised.  
 
HSE’s assessment reaches the  same conclusion as the EU exposure assessment 
conducted for the three  representative products.  Exposure estimates for mancozeb 
and combined exposure for mancozeb and ETU have not been demonstrated at 
acceptable levels below the reference values for all e xposed groups (operators, 
residents, bystanders and workers).  
 
In addition, two hazard -based cut -off criteria for approval were identified as critical 
areas of concern.  Negligible exposure could not be demonstrated as non -dietary 
exposure exceeds the refe rence values for the representative uses.   Therefore , 
based on the representative products and uses , HSE concludes that the 
requirements for this area of the risk assessment are not met and regulatory action is 
warranted .