COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009
Date: 2016-03-17
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, EU environmental policy, fertiliser, fertiliser industry, harmonisation of standards, labelling, market approval, single market

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   EUROPEAN COMMISSION  Brussels, 17.3.2016  SWD(2016) 65 final   COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT  Accompanying the document Proposal for a Regulation of the European Parliament and of the Council laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 {COM(2016) 157 final} {SWD(2016) 64 final}  
 
 
Executive Summary Sheet 

Impact assessment on a proposal for a Regulation of the European Parliament and of the Council  

on the making available on the market of fertilising products 

A. Need for action 

Why? What is the problem being addressed?  
The  conditions  for  access  to  the  market  of  fertilising  products  are  only  partially  harmonised  at  EU  level.  The 
fragmentation of the non-harmonised part of the market is seriously hindering trade opportunities. Moreover, the 
harmonised legislation does not sufficiently address environmental and human health issues. More specifically, 
the following operational problems could be identified: 
1)  Companies  operating  in  several  Member  States  on  the  non-harmonised  market  are  facing  the  costs  of 
diverging national rules, which often include prior authorisation which is difficult to obtain. 
2)  Serious  concerns  have  been  identified  relating  to  health  and  the  environment,  in  particular  the  presence  of 
toxic  contaminants  in  certain  widely  used  fertilisers.  The  current  harmonisation  legislation  provides  insufficient 
protection of health and the environment.  
3) The current harmonised legislation grants market access through a procedure which has been proven to be 
too slow in relation to the innovation cycle of industry. 

What is this initiative expected to achieve?  

The initiative is expected to: 

1.  Create  a  level  playing  field  for  all  fertilising  products  at  EU  level,  thereby  increasing  the  industry's 
opportunities to have access to the Internal Market while maintaining the national regulations in place for 
products limited to national markets, hence avoiding any market disruption. 
Increase  the  level  of  protection  of  health  and  environmental  protection  by  limiting  the  presence  of 
contaminants in fertilising materials and additives throughout the EU.  

2. 

Facilitate access to the harmonised market by introducing a proportionate, cost effective, transparent and flexible 
regulatory framework, thereby responding to the needs of EU farmers for innovative products. 

What is the value added of action at the EU level?  

The problems identified in the harmonised market (i.e., insufficient protection of human health and of the 
environment, and inflexible requirements providing too slow market access), are inherent to the current EU level 
and can therefore only be corrected by EU level action. An effective EU-wide market for all fertilising products 
will open up new market opportunities and reduce administrative burdens. 
However, in view of the very local nature of the market of certain fertilising products, this EU- harmonised action 
will  be  optional  and  co-exist  with  national  legislations  maintained  or  introduced  by  Member  States  and  mutual 
recognition.  

B. Solutions 

What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a  preferred 
choice or not? Why?  
Option 1: Baseline scenario – The current EU legislation remains unchanged.  
Option 2: The regulatory technique of the Fertilisers Regulation, i.e. type-approval, remains un-changed, and is 
extended  to  the  harmonisation  of  fertilisers  from  organic  raw  materials  and  of  other  fertiliser-related  products, 
such as 'plant biostimulants'.  
Option  3:  Harmonisation  through  approval  of  ingredients,  leading  to  a  positive,  exhaustive  list  of  materials 
eligible for intentional incorporation into a fertilising product.  
Option 4: Harmonisation through the New Legislative Framework (NLF), which builds on mandatory, quality and 
safety requirements and voluntary, harmonised technical standards.  
Option  5:  As  under  option  4,  harmonisation  is  achieved  through  the  'New  Legislative  Framework'  with 
requirements  and  standards.  However,  third  party  involvement  in  the  assessment  of  conformity  with  the 
requirements  varies  between  material  categories,  and  is  highest  for waste and  other  secondary  materials  with 
potentially variable composition. Option 5 emerges as the preferred option from the analysis. 
For  options  2  to  5,  limit  values  are  introduced  for  contaminants  (including  heavy  metals)  for  all  fertilising 

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products. Two variants were assessed: full and optional harmonisation as described above. 

Who supports which option?  
Option 1 is not supported by any Member States, industry or NGOs. 
Options 2 and 3 are each supported by some Member States and some national industry federations, who are 
used to regulating the fertiliser market by maintaining lists of authorised types or ingredients. 
Option  4  is  not  supported  by  all  Member  States,  as  the  NLF  is  considered  a  radical  change  compared  to  the 
well-known Option 2 and 3 approaches.  
Option 5, especially with the optional harmonisation variant, is generally well accepted by industry (in particular 
SMEs) and a large number of Member States (including some of the largest) as the best option. 

C. Impacts of the preferred option 

What are the benefits of the preferred option (if any, otherwise main ones)?  
Access to the market for fertilising products regulated under the NLF would be eased, and compliance of such 
products with safety and quality requirements would ensure an increased level of safety in the food chain.  The 
benefits in terms of internal market access and market flexibility of the preferred option (option 5) are very similar 
to those of option 4. The Impact Assessment estimates that this option will provide lower administrative costs for 
both public authorities and economic operators than status quo, and significantly lower administrative costs for 
public  authorities  than  the  type-approval  option  which  would  significantly  increase  market  flexibility  and  hence 
stimulate innovation. 
The variant of optional harmonisation would have the additional advantage of affecting only economic operators 
with a genuine interest in getting access to the market in several Member  States, in line with the principles of 
subsidiarity and better regulation. 

What are the costs of the preferred option (if any, otherwise main ones)?  
The costs of the preferred option are proportionate to the expected benefits for businesses and the society. The 
costs  for  public  authorities  are  rather  neutral.  Some  additional  standardisation  work  regarding  test  methods 
would be required for products subject to the NLF.  
Option  5  would  imply  lower  administrative  costs  than  the  type-approval  option  for  economic  operators.  It  can, 
however, be expected that administrative costs will in certain cases be higher than under status quo at the level 
of individual companies. This would be true in particular for producers of relatively variable materials requiring a 
high level of third-party involvement in the conformity assessment. SMEs involved in the production of fertilising 
products subject to third party certification would have to pay fees to a notified body to verify the compliance of 
their products with the requirements. The variant of optional harmonisation could imply higher costs for national 
administrations than full harmonisation, since they could be expected to maintain  national procedures to some 
extent. Transition costs would be minimal for fertilising products yet covered by the current Regulation as self-
certification of products will be allowed. Member States would also need to ensure the quality of notified bodies.  

How will businesses, SMEs and micro-enterprises be affected?  

Companies opting for the harmonised route would benefit from facilitated access to the entire EU market. The 
administrative costs would also decrease, as there would be less need to register individual products according 
to  diverging  national  rules.  Producers  not  subject  to  third  party  certification  procedures  would  be  less affected 
compared to those supporting the costs of third party certification (e.g. SMEs). Those costs would be mitigated 
by  the  reduction  of  the  frequency  of  controls  according  to  the  volume  of  production  and  the  reduction  of  the 
number of external samplings after the recognition year. In this sense optional harmonisation would facilitate the 
smooth transition to the new regulatory framework leaving producers the choice to market product either for the 
local or for the EU markets.   

Will there be significant impacts on national budgets and administrations?  
Costs would be rather neutral for national budgets. The costs  of  governance of national legislation will remain 
the same but will be reducing over time if more and more companies opt for the harmonised route offered by the 
Fertilisers Regulation, while the market surveillance costs will remain the same or may slightly increase. 

Will there be other significant impacts?  
The proposal is expected to reduce the dependency of non-domestic raw materials, by offering an opportunity 
for  an  easier  access  to  the  entire  EU  market  for  innovative  products  made,  e.g.,  from  organic  or  recycled 
materials. EU import flows could be affected, as analysed in detail in a separate impact assessment of 2011 on 
possible maximum limits for cadmium.  

When will the policy be reviewed?  

D. Follow up 

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An ex-post evaluation of the Regulation is foreseen 5 years after its implementation and will be based on the 
feedback received through various cooperation mechanisms already established under the current Fertilisers 
Regulation (expert groups).The list of contaminants and their respective limit values could be reviewed at any 
time, if new scientific evidence would show that soil contaminant inputs from fertilisers have to be reduced. 

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