EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 17.3.2016  
COM(2016) 157 final  
2016/0084 (COD)  
  
Circular Economy Package  
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  
(Text with EEA relevance)  
{SWD(2016) 64 final}  
{SWD(2016) 65 final}   EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL  
• Reasons for and objectives of the proposal  
1. The proposal aims at addressing important problems currently present on the market, 
which were first identified in an ex -post evaluation of Regulation  (EC) 
No 2003/2003 ('the existing Fertilisers Regulation') conducted in 2010.1 It has also 
been identified as one of the key legislative proposals under the Circular Economy 
action plan.2 
 The first reason and objective  
2. First, innovative fertilising products, often containing nutrients or organic matter 
recycled from biowaste or other secondary raw materials in  line with the circular 
economy model, have difficulties accessing the internal market due to the existence 
of diverging national rules and standards.  
3. The existing Fertilisers Regulation ensures free movement on the internal market of a 
class of harmoni sed products belonging to one of the product -types included in 
Annex  I to that Regulation. Such products are eligible to be labelled 'EC -fertilisers'. 
Companies wishing to market products of other types as EC -fertilisers must first 
obtain a new type -approv al through a Commission decision amending that Annex. 
Virtually all product -types currently included in the existing Fertilisers Regulation 
are conventional, inorganic fertilisers, typically extracted from mines or chemically 
produced in line with a linear  economy model. Also, the chemical processes for 
producing for example nitrogen -based fertilisers are both energy consuming and 
CO 2-intensive.  
4. Around 50 % of the fertilisers currently on the market, however, are left out of the 
scope of the Regulation. This is true for a few inorganic fertilisers and for virtually 
all fertilisers produced from organic materials, such as animal or other agricultural by 
products, or recycled bio -waste from the food chain. Research, innovation and 
investment are currently d eveloping rapidly, contributing to the circular economy by 
creating local jobs and by generating value from secondary, domestically sourced 
resources which would otherwise have been used directly on land or disposed as 
landfill waste, causing unnecessary e utrophication and greenhouse gas emissions. 
There is also a servitization trend in the business, with increasing product 
customisation based on analysis of the soil where the fertiliser will be used. SMEs 
and other enterprises throughout Europe are increas ingly interested in contributing to 
this development. However, for customised products containing organic fertilisers, 
access to the internal market is currently depending on mutual recognition, and 
therefore often hindered.  
5. The problem for innovative fertilisers with the existing regulatory construction is 
two-fold 
6. The first angle of the problem is that inclusion in the existing Fertilisers Regulation 
of types of products sourced from organic or secondary raw material is challenging. 
Regulators hesi tate because of the relatively variable composition and characteristics 
of such materials. The existing Fertilisers Regulation is clearly tailored for well 
                                                 
1 http://ec.europa.eu/smart -regulation/evaluation/search/download.do?documentId=4416   
2 COM(2015) 614/2  EN 3   EN characterised, inorganic fertilisers from primary raw materials, and lacks the robust 
control mechan isms and safeguards necessary for creating trust in products from 
inherently variable organic or secondary material sources. Furthermore, the links 
with existing legislation on control of animal by -products and waste are not clear.  
7. As a result, fertilisers sourced in line with the circular economy remain non -
harmonised. Many Member States have detailed, national rules and standards in 
place for such non -harmonised fertilisers, with environmental requirements (such as 
heavy metal contaminant limit s) that do not apply to EC -fertilisers. Furthermore, free 
movement between Member States through mutual recognition has proven extremely 
difficult. As a result, a producer of fertilisers sourced from organic or secondary raw 
materials, established in one M ember State and seeking to expand its market to the 
territory of another Member State, is often faced with administrative procedures 
making the market expansion prohibitively expensive. The resulting lack of critical 
mass hampers investment in this importa nt sector of the circular economy. The 
problem is of particular importance for producers established in Member States with 
a small domestic market compared to the surplus of organic, secondary raw materials 
(typically manure) of which they dispose.  
8. In summary, the playing field in the competition between those fertilisers sourced 
from domestic organic or secondary raw material in line with the circular economy 
model and those produced in line with a linear economy model is tilted in favour of 
the latter.  This competition distortion hampers investment in the circular economy.  
9. The problem is aggravated by the fact that one of the main fertiliser constituents is 
phosphate rock, which has been identified by the Commission as a critical raw 
material. For ph osphate fertilisers, the EU is currently highly dependent on import of 
phosphate rock mined outside of the EU (more than 90% of the phosphate fertilisers 
used in the EU are imported, mainly from Morocco, Tunisia and Russia). This while 
domestic waste (in p articular sewage sludge) contains large amounts of phosphorus, 
which – if recycled in line with a circular economy model – could potentially cover 
about 20 -30% of EU's demand of phosphate fertilisers. The related investment 
potential remains, however, curr ently largely unexploited, which is partially due to 
the above -mentioned difficulties to access the internal market.  
10. The second angle of the current Fertilisers Regulation's limitations for innovative 
fertilisers is that, even for new, inorganic fertil isers from primary raw materials, the 
type-approval procedure is lengthy, and cannot keep up with the innovation cycle of 
the fertilisers sector. It has therefore been deemed necessary to fundamentally 
reconsider and modernise the regulatory technique, in order to increase flexibility 
with regard to product requirements, while maintaining a high level of protection of 
human, animal, and plant health, safety and the environment. The considerations 
undertaken in this respect are detailed below in Section  3: Results of ex -post 
evaluations, stakeholder consultations and impact assessment . 
11. The main policy objective of the initiative is therefore to incentivise large scale 
fertiliser production in the EU from domestic organic or secondary raw materials in 
line with the circular economy model, by transforming waste into nutrients for crops. 
The proposal will provide a regulatory framework radically easing access to the 
internal market for such fertilisers, thereby levelling their playing field with that of 
mined  or chemical fertilisers produced in line with a linear economy model. This 
would contribute to the following circular economy objectives:  EN 4   EN  It would allow valorisation of secondary raw materials, hence enabling 
improved use of raw materials and turning eutrophication and waste 
management problems into economic opportunities for public and private 
operators.  
 It would increase resource efficiency and decrease import dependency for raw 
materials essential to European agriculture, in particular phosphorus.  
 It would boost investment and innovation in the circular economy, hence 
creating jobs in the EU.  
 It would contribute to relieving the fertilisers industry from its current pressure 
to reduce CO 2-emissions under ETS, by allowing it to produce fertilisers fr om 
less carbon -intensive feedstock.  
12. Increased production and trade in innovative fertilisers would also diversify the 
fertilisers offered to farmers, potentially contributing to making food production 
more cost - and resource -effective.  
 The second rea son and objective  
13. Second, the existing Fertilisers Regulation fails to address environmental concerns 
arising from contamination by EC -fertilisers of soil, inland waters, sea waters, and 
ultimately food. A well -recognised issue is the presence of cadmi um in inorganic 
phosphate fertilisers. In the absence of EU limit values, some Member States have 
imposed unilateral cadmium limits for EC -fertilisers by virtue of Article 114 TFEU, 
hence creating a certain market fragmentation also in the harmonised field . The 
presence of contaminants in those fertilisers which are currently subject to national 
rules ( e.g. nutrients recycled from sewage sludge) poses similar concerns.  
14. A second policy objective is therefore to address this issue and introduce harmonised  
cadmium limits for phosphate fertilisers. The setting of such limit values, aiming at 
minimising the negative impact of fertiliser use on the environment and on human 
health, will contribute to a reduction of cadmium accumulation in soil and of 
cadmium co ntamination of food and water. It will also remove the market 
fragmentation to which the concern currently gives rise in the form of national 
cadmium limits in some Member States.  
• Consistency with existing policy provisions in the policy area  
15. The pro posal will repeal the existing Fertilisers Regulation, but allow already 
harmonised fertilisers to remain on the market subject to compliance with the new 
safety and quality requirements. It will define the conditions under which fertilisers 
produced from waste and animal by -products can leave the controls provided for by 
Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 
21 October 2009 laying down health rules as regards animal by -products and derived 
products not intended for h uman consumption and repealing Regulation  (EC) 
No 1774/2002 (Animal by -products Regulation)3 and the Directive  2008/98/EC on 
waste and repealing certain Directives4 and circulate freely as CE marked fertilisers. 
It will be complementary to Regulation (EC) No 1907/2006 of the European 
Parliament and of the Council of 18  December 2006 concerning the Registration, 
                                                 
3 OJ L 300, 14.11.2009, p.  1. 
4 OJ L 312, 22.11.2008, p.  3. EN 5   EN Evaluation, Authorisation and Restriction of Chemicals (REACH)5, which will 
continue to apply to chemical substances incorporated into fertilising p roducts.  
• Consistency with other Union policies  
16. The initiative supports the Commission's agenda for jobs, growth and investment,  by 
providing the right regulatory environment for investment in the real economy.  
17. In particular, the initiative will make an important and concrete contribution to the 
Commission's Circular Economy Package. It will create a level playing field for all 
fertilising products and facilitate recourse to domestic, secondary raw materials.  
18. Furthermore, the initiative suppor ts the aim to create a deeper and fairer internal 
market with a strengthened industrial base, by removing existing barriers to free 
movement of certain innovative fertilisers and facilitating the market surveillance by 
Member States.  
19. The initiative is related to the following policy initiatives:  
 The Circular Economy Package: The Fertilisers Regulation revision aims at 
establishing a regulatory framework enabling production of fertilisers from 
recycled bio -wastes and other secondary raw materials, in lin e with the 
Bioeconomy strategy6, which encompasses the production of renewable 
biological resources and the conversion of these resources and waste streams 
into value added products. This would boost domestic sourcing of plant 
nutrients which are essential  for a sustainable European agriculture, including 
the critical raw material phosphorus. It would also contribute to a better 
implementation of the waste hierarchy, by minimising landfilling or energy 
recovery of bio -wastes, and hence to solving related wa ste management 
problems.  
 The Single Market Strategy: As described above, a well -known barrier to free 
movement on the internal market constitutes of heavy and diverging national 
regulatory frameworks for those fertilisers currently not covered by 
harmonisa tion legislation. While economic operators often regard the diverging 
national rules as a prohibitive obstacle to entering new markets, Member States 
regard the rules as essential for protecting the food chain and the environment.  
Because of those concerns  relating to health and the environment, mutual 
recognition has proven exceptionally difficult in the field of non -harmonised 
fertilisers, and economic operators have asked for the possibility to get access 
to the entire internal market by complying with h armonised rules addressing 
those concerns at EU level.  
 Horizon 2020: The proposal will have the potential to stimulate relevant 
research activities launched under Societal Challenges 2 (“Food security, 
sustainable agriculture and forestry, marine and marit ime and inland water 
research, and the Bioeconomy”) and 5 (“Climate action,  environment, resource 
efficiency and raw materials”), which aim, among other objectives, at 
providing innovative solutions for a more efficient and safer recovery of 
resources from  waste, wastewater and bio -wastes, and at encouraging 
researchers to deliver innovative products in compliance with the market 
needs, the societal needs and the environmental protection policies. The Bio 
                                                 
5 OJ L 396, 30.12.2006, p.  1. 
6 http://ec.europa.eu/research/bioeconomy/index.cfm  EN 6   EN Based Industries Joint Undertaking has identified i.a. phosphorus recycling for 
production of fertilisers as an emerging and economically promising new value 
chain from (organic) waste.7 Easy access to the internal market for such 
fertilizers would be a pre -condition for achieving these goals and bringing 
results from research to the market.  
2. LEGAL  BASIS,  SUBSIDIARITY  AND  PROPORTIONALITY  
• Legal  basis  
20. The aim of the proposal is to improve the functioning of the internal market for 
fertilising products, hence addressing the issues first identified in th e ex -post 
evaluation of the existing Fertilisers Regulation conducted in 2010.  The legal basis is 
therefore Article 114 of the Treaty on the Functioning of the European Union, which 
is also the legal basis for the existing Fertilisers Regulation.  
• Subsidi arity  (for non-exclusive  competence)   
21. The first objective of the proposed action is to boost investment in production and 
uptake of effective, safe, innovative fertilisers produced from organic or secondary 
raw materials in line with the circular econo my model and the Bioeconomy strategy, 
by helping those products reach a critical mass through access to the entire internal 
market. More efficient recourse to such fertilisers can offer significant environmental 
benefits, reduced dependency on import of cr itical raw materials from outside of the 
EU, as well as an increased variety of high quality fertilising products to farmers. 
The existing barriers to the free movement of such products, in the form of 
diverging, national regulatory frameworks, cannot be r emoved through Member 
States' unilateral actions. In particular, mutual recognition in this field has proven 
exceptionally difficult, and becomes an increasingly important obstacle as the 
interest in producing and trading high -quality fertilisers from orga nic or secondary 
raw materials tends to increase. EU action, on the other hand, could ensure the free 
movement of such fertilisers by establishing harmonised high quality, safety and 
environmental criteria.  
22. The second objective is to address cadmium c ontamination of soil and food through 
fertiliser use. Since most of the fertilisers from which the concern originates ( i.e., 
inorganic phosphate fertilisers) are already harmonised, Member States cannot 
achieve this objective unilaterally. EU -wide maximum limits, on the other hand, can 
effectively reduce contaminants in harmonised fertilisers to safer levels.  
• Proportionality  
23. The first objective of the initiative is that of boosting investment in production of 
effective, safe, innovative fertilisers p roduced from organic or secondary raw 
materials in line with the circular economy model, with the related benefits for 
environmental impact, reduced import dependency, and increased variability of high -
quality products on offer. The initiative aims at reac hing a critical mass through 
internal market for such products. Mutual recognition of non -harmonised fertilisers 
has proven extremely difficult in the past, whereas product harmonisation legislation 
has been an effective way of securing internal market acc ess for inorganic fertilisers. 
It is therefore concluded that product harmonisation legislation for fertilisers from 
organic or secondary raw materials does not go beyond what is necessary for 
                                                 
7 http://bbi -europe.eu/sites/default/files/documents/BBI_JU_annual_Work_plan_2014.pdf   EN 7   EN providing the regulatory certainty required to incentivise larg e scale investment in 
the circular economy. The regulatory technique chosen in this proposal leaves 
economic operators a maximum of flexibility to put new products on the markets 
without compromising on safety and quality. Furthermore, it leaves Member Sta tes 
free to allow non -harmonised fertilisers to on the market, without depriving those 
economic operators seeking larger markets of the possibility to opt for the benefits of 
the harmonised regulatory framework.  
24. The form of a Regulation is deemed the most appropriate for harmonisation of 
products in a field of such technical complexity and potential impact on the food 
chain and the environment as fertilisers. That conclusion is supported by the fact that 
the exist ing harmonisation legislation for fertilisers also has the form of a Regulation.  
25. Regarding the second objective, i.e., addressing cadmium contamination of soil and 
food through use of fertilisers many of which are already harmonised, maximum 
levels in  the product legislation is seen as an effective means of addressing the 
problem at source. The economic impacts are deemed proportionate to the objective 
of preventing irrevocable soil contamination affecting current and future generations 
of farmers and food consumers.  
26. The proportionality is further developed in section 4.2.2 of the Impact Assessment.  
• Choice  of the instrument  
27. The form of a Regulation is deemed the most appropriate for harmonisation of 
products in a field of such technical complexity and potential impact on the food 
chain and the environment as fertilisers. That conclusion is supported by the fact that 
the existing harmonisation legislation for fertilisers also has the form of a Regulation.  
3. RESULTS  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS  
• Ex-post evaluations/fitness  checks  of existing  legislation  
28. The ex-post evaluation of the existing Fertilisers Regulation conducted in 2010 
concluded8 that the Regulation had been effective in meeting its objective of 
simplifying and harmonising the regulatory framework in relation to an important 
part of the fertiliser market.  
29. However, the evaluation also concluded that the Regulation could be more effective 
in promoting innovative fertilisers, an d that adjustments would also be needed to 
better protect the environment. Furthermore, regarding the organic fertilisers 
currently left out of the scope of the Regulation, the evaluation showed that neither 
economic operators, nor national authorities con sidered that mutual recognition was 
the most appropriate tool for ensuring free movement, since fertilisers are products 
for which legitimate product quality, environmental, and human health concerns can 
warrant stringent rules.  
• Stakeholder  consultations  
30. Consultation of Member States and other stakeholders has been conducted 
extensively throughout the preparatory phase starting in 2011, in particular in the 
                                                 
8 See Section 4, Conclusions and recommendations.  EN 8   EN context of the Fertilisers Working Group.9 The public consultation on Circular 
economy publishe d in May 2015 included questions on this topic.10 Stake holders 
were also invited to give feedback to the Roadmap for the revision of the Fertilisers 
Regulation published on 22  October  2015.11 
• Collection  and use of expertise  
31. The existing draft Impact A ssessment report relies largely on the abovementioned 
ex-post evaluation of the Fertilisers Regulation of 2010 as well as on the study 
carried out in 2011 on options to fully harmonise the EU legislation on fertilising 
materials including technical feasibi lity, environmental, economic and social 
impacts12. 
32. Phosphorus recycling has also been addressed by FP7 research projects, the results of 
which have been analysed during the workshop 'Circular approaches to phosphorus: 
from research to deployment', held  in Berlin on 4 March 201513. One of the 
identified priorities is to revise the EU Fertiliser Regulation to extend its scope to 
nutrients from secondary sources ( e.g. recycled phosphates) and organic sources.  
• Impact  assessment  
33. The proposal is supporte d by an impact assessment, the key documents of which can 
be found [Once the IAR is published, insert link to the summary sheet and to the 
positive opinion of the Regulatory Scrutiny Board]. The opinions of the Impact 
Assessment Board were taken into accou nt by providing better evidence of the 
divergent national standards as a cause for market fragmentation, by clarifying the 
content of the various options assessed, and by better justifying the key impacts of 
the proposal.  
34. The impact assessment compare d status quo  (referred to as option 1) with four other 
policy options (referred to as options 2 -5). Under all of the options 2 -5, the scope of 
harmonisation would be extended to fertilisers from organic raw materials and to 
other fertiliser -related product s, and limit values would be introduced for 
contaminants. The options would build on different control mechanisms: Under 
option 2, the regulatory technique of the Fertilisers Regulation, i.e., type -approval, 
would remain un -changed. Under option 3, the typ e-approval would be replaced by a 
positive, exhaustive list of materials eligible for intentional incorporation into a 
fertiliser. Option 4 would achieve the necessary control through the 'New Legislative 
Framework' ('NLF'), with one conformity assessment procedure applicable across the 
board. Finally, option 5 would also build on the NLF, but the conformity assessment 
procedure would vary between material categories. For all four options 2 -5, it was 
also examined whether the harmonisation should be mandato ry for all products with 
a given function, or whether fertilisers could comply with the harmonised legislation 
                                                 
9 For activity reports of that group's meetings, see 
http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=1320& Ne
wSearch=1&NewSearch=1   
10
 http://ec.europa.eu/environment/consultations/closing_the_loop_en.htm?utm_content=buffer6
8ffa&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer  
11 http://ec.europa.eu/smart -regulation/roadmaps/docs/2012_grow_001_fertilisers_en.pdf   
12 http://bookshop.europa.eu/en/study -on-options -to-fully -harmonise -the-eu-legislation -on-fertilising -
materials -including -technical -feasibility -environmental -economic -and-social -impacts -pbNB0114252/   
13 The report of the workshop can be downloaded at http://bookshop.europa.eu/en/circular -approaches -to-
phosphorus -pbKI0115204/  EN 9   EN on an optional basis, as an alternative to any applicable national legislation and 
mutual recognition, as is the case under status quo  for inorganic fertilisers.  
35. The final proposal corresponds with option  5, coupled with the variant of optional 
harmonisation. It was considered to be the best policy choice because it would lead 
to administrative simplification, in particular for ferti lising products from well 
identified, primary raw materials, and ensure flexibility, while at the same time 
ensuring that the use of harmonised fertilising products does not pose unacceptable 
risks to health or the environment.  
36. The proposal will mainly  affect those producers of innovative fertilisers produced 
from organic or secondary raw materials in line with the circular economy model, 
who will be able to reach a critical mass through radically facilitated access to the 
internal market. Such producer s will benefit from the initiative in particular in those 
Member States which are not providing a sufficiently large home market for new 
types of fertilisers.  
37. It will also affect private and public recovery operators (such as operators of waste 
water t reatment plants, or of waste management plants producing compost or 
digestate) who will be able to valorise their output, and thus facilitate investments in 
such infrastructure.  
38. Many national authorities will see a decreased workload when national reg istration 
or authorisation systems for fertilisers are fully or partially replaced by EU -wide 
control mechanisms.  
39. Finally, farmers and other fertiliser users are likely to see an increase in the product 
variety offered to them, while the general publi c will be better protected from 
contamination of soil, water and food.  
• Regulatory  fitness  and simplification  
40. The proposal will lead to simplification and reduction of the administrative burden 
for producers of fertilising products seeking access to m ore than one national 
territory on the internal market, since such access will no longer depend on mutual 
recognition. At the same time, it will avoid banning or restricting market access for 
producers that do not aim at compliance with EU -level rules, by keeping open the 
possibility to access national markets subject to any national rules and mutual 
recognition.  
4. BUDGETARY  IMPLICATIONS  
41. The proposal will have no implications on the EU budget. Human and administrative 
resources within the European Comm ission will remain unchanged compared with 
the implementation and monitoring of the existing Fertilisers Regulation.  
5. OTHER  ELEMENTS  
• Implementation  plans  and monitoring,  evaluation  and reporting  arrangements  
42. The European Commission will assist and monitor Member States' implementation 
of the Regulation. It will also analyse the need for guidance, standards or schemes 
proving sustainability of fertilising products, thus allowing sustainability -claims on 
the product labels.  EN 10   EN 43. The Commission further more intends to include additional component material 
categories in the Annexes, to keep up with technological progress allowing the 
production of safe and effective fertilisers from recovered, secondary raw materials, 
such as biochar, ashes and struvite. Finally, the Commission will keep the 
requirements in the Annexes under constant review, and revise them wherever 
necessary to provide an adequate protection of human, animal or plant health, safety 
or the environment.  
• Detailed  explanation  of the specifi c provisions  of the proposal  
44. Chapter  1 of the proposed Regulation sets out the subject matter, scope and 
definitions, as well as the fundamental principles of free movement and marketability 
of CE marked fertilising products. The provision on product requirements refers to 
Annexes  I and II, which contain the substantive requirements for the categories of 
end-products in accordance with their intended function (Annex  I), as well as for the 
categories of component materials that can be contained in CE ma rked fertilising 
products (Annex  II). It also refers to Annex  III, which specifies the labelling 
requirements.  
45. Chapter  2 lays down the obligations of economic operators involved in making 
CE marked fertilising products available on the market.  
46. Chapter 3 sets out the general principle for conformity of CE  marked fertilising 
products. It refers to Annex  IV, which describes in detail the conformity assessment 
procedures applicable to CE  marked fertilising products, depending on their 
component materia l categories and their product function categories. It also refers to 
Annex  V, which sets out the model structure for the EU declaration of conformity.  
47. Chapter  4 sets out the provisions on notified bodies, and Chapter  5 sets out the 
provisions on marke t surveillance. Chapter  6 sets out the conditions for the 
Commission's adoption of delegated and implementing acts, and Chapter  7 sets out 
final provisions.  EN 11   EN 2016/0084 (COD)  
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  
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,  
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 114 thereof,  
Having regard to the proposal from the European Commission,  
After transmission of the draft legislative act to the national parliaments,  
Having regard to the opinion of the European Economic and Social Committee14, 
Acting in accordance with the ordinary legislative procedure,  
Whereas:  
(1) The conditions for making fertilisers available on the internal market have been 
partially harmonised through Regulation  (EC) No  2003/2003 of the European 
Parliament and of the Council15, which almost exclusively covers fertilisers from 
mined or chemically produced, inorg anic materials. There is also a need to make use 
of recycled or organic materials for fertilising purposes. Harmonised conditions for 
making fertilisers made from such recycled or organic materials available on the entire 
internal market should be establis hed in order to provide an important incentive for 
their further use. The scope of the harmonisation should therefore be extended in order 
to include recycled and organic materials.  
(2) Certain products are being used in combination with fertilisers for th e purpose of 
improving nutrition efficiency, with the beneficial effect of reducing the amount of 
fertilisers used and hence their environmental impact. In order to facilitate their free 
movement on the internal market, not only fertilisers, i.e. products intended to provide 
plants with nutrient, but also products intended to improve plants' nutrition efficiency, 
should be covered by the harmonisation.  
(3) Regulation (EC) No 765/2008 of the European Parliament and of the Council16 lays 
down rules on the accr editation of conformity assessment bodies, provides a 
framework for the market surveillance of products and for controls on products from 
third countries, and lays down the general principles of the CE marking. That 
                                                 
14 OJ C , , p. .  
15 Regulati on (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 
relating to fertilisers (OJ L 304, 21.11.2003, p. 1).  
16 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the requireme nts for accreditation and market surveillance relating to the marketing of products and 
repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).  EN 12   EN Regulation should be applicable to produ cts covered by the scope of this Regulation in 
order to ensure that products benefiting from the free movement of goods within the 
Union fulfil requirements providing a high level of protection of public interests such 
as health and safety in general, prot ection of consumers and protection of the 
environment.  
(4) Decision No 768/2008/EC of the European Parliament and of the Council17 lays down 
common principles and reference provisions intended to apply across sectoral 
legislation in order to provide a coher ent basis for revision or recasts of that 
legislation. Regulation  (EC) No  2003/2003 should therefore be replaced by a 
Regulation drafted to the extent possible in accordance with that Decision.  
(5) Contrary to most other product harmonisation measures in U nion legislation, 
Regulation  (EC) No  2003/2003 does not prevent non -harmonised fertilisers from 
being made available on the internal market in accordance with national law and the 
general free movement rules of the Treaty. In view of the very local nature of certain 
product markets, this possibility should remain. Compliance with harmonised rules 
should therefore remain optional, and should be required only for products, intended to 
provide plants with nutrient or improve plants' nutrition efficiency, which  are 
CE marked when made available on the market. This Regulation should therefore not 
apply to products which are not CE marked when made available on the market.  
(6) Different product functions warrant different product safety and quality requirements 
adapted to their different intended uses. CE marked fertilising products should 
therefore be divided into different product function categories, which should each be 
subject to specific safety and quality requirements.  
(7) Similarly, different component mate rials warrant different process requirements and 
control mechanisms adapted to their different potential hazardousness and variability. 
Component materials for CE  marked fertilising products should therefore be divided 
into different categories, which shou ld each be subject to specific process 
requirements and control mechanisms. It should be possible to make available on the 
market a CE  marked fertilising product composed of several component materials 
from various component material categories, where each  material complies with the 
requirements of the category to which the material belongs.  
(8) Contaminants in CE  marked fertilising products, such as cadmium, can potentially 
pose a risk to human and animal health and the environment as they accumulate in th e 
environment and enter the food chain. Their content should therefore be limited in 
such products. Furthermore, impurities in CE  marked fertilising products derived from 
bio-waste, in particular polymers but also metal and glass, should be either prevente d 
or limited to the extent technically feasible by detection of such impurities in 
separately collected bio -waste before processing.  
(9) Products complying with all the requirements of this Regulation should be allowed to 
move freely on the internal market. Where one or more of the component materials in 
a CE  marked fertilising product falls within the scope of Regulation (EC) 
No 1069/2009 of the European Parliament and of the Council18, but reaches a point in 
                                                 
17 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common 
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 
13.8.2008, p. 82).  
18 Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 
laying down health rules as regards animal by -products and derived products not intended for human EN 13   EN the manufacturing chain beyond which it no  longer poses any significant risk to public 
or animal health (the 'end point in the manufacturing chain'), it would represent an 
unnecessary administrative burden to continue subjecting the product to the provisions 
of that Regulation. Such fertilising pr oducts should therefore be excluded from the 
requirements of that Regulation. Regulation (EC) No 1069/2009 should therefore be 
amended accordingly.  
(10) The end point in the manufacturing chain should be determined for each relevant 
component material cont aining animal by -products in accordance with the procedures 
laid down in Regulation (EC) No 1069/2009. Where a manufacturing process 
regulated under this Regulation starts already before that end point has been reached, 
the process requirements of both Reg ulation (EC) No  1069/2009 and this Regulation 
should apply cumulatively to CE  marked fertilising products, which means application 
of the stricter requirement in case both Regulations regulate the same parameter.  
(11) In the event of risks to public or an imal health from CE  marked fertilising products 
derived from animal by -products, recourse to safeguard measures in accordance with 
Regulation  (EC) No  178/2002 of the European Parliament and of the Council19 should 
be possible, as is the case for other categ ories of products derived from animal by -
products.  
(12) Where one or more of the component materials for a CE  marked fertilising product fall 
within the scope of Regulation (EC) No 1069/2009 and has not reached the end point 
in the manufacturing chain, it would be misleading to provide for the product's CE 
marking under this Regulation, since the making available on the market of such a 
product is subject to the requirements of Regulation (EC) No 1069/2009. Therefore, 
such products should be excluded from t he scope of this Regulation.  
(13) For certain recovered wastes within the meaning of Directive  2008/98/EC of the 
European Parliament and of the Council20, a market demand for their use as fertilising 
products has been identified. Furthermore, certain requir ements are necessary for the 
waste used as input in the recovery operation and for the treatment processes and 
techniques, as well as for fertilising products resulting from the recovery operation, in 
order to ensure that the use of those products does not  lead to overall adverse 
environmental or human health impacts. For CE  marked fertilising products, those 
requirements should be laid down in this Regulation. Therefore, as of the moment of 
compliance with all the requirements of this Regulation, such prod ucts should cease to 
be regarded as waste within the meaning of Directive  2008/98/EC.  
(14) Certain substances and mixtures, commonly referred to as agronomic additives, 
improve the nutrient release pattern of a nutrient in a fertiliser. Substances and 
mixtures made available on the market with the intention of them being added to 
CE marked fertilising products for that purpose should fulfil certain efficacy criteria at 
the responsibility of the manufacturer of those substances or mixtures, and should 
theref ore as such be considered as CE  marked fertilising products under this 
Regulation. Furthermore, CE  marked fertilising products containing such substances 
or mixtures should be subject to certain efficacy and safety criteria. Such substances 
                                                                                                                                                         
consumption and repealing Regulation (EC) No 1774/2002 (Animal by -products Regulation) 
(OJ L 300, 14.11.2009, p.  1). 
19 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Janua ry 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety (OJ L  31, 1.2.2002, p.  1). 
20 Directive 2008/98/EC of the European Parliament and o f the Council on waste and repealing certain 
Directives (OJ  L 312, 22.11.2008, p.  3). EN 14   EN and mixtures sh ould therefore also be regulated as component materials for 
CE marked fertilising products.  
(15) Certain substances, mixtures and micro -organisms, commonly referred to as plant 
biostimulants, are not as such nutrients, but nevertheless stimulate plants' nu trition 
processes. Where such products aim solely at improving the plants' nutrient use 
efficiency, tolerance to abiotic stress, or crop quality traits, they are by nature more 
similar to fertilising products than to most categories of plant protection pro ducts. 
Such products should therefore be eligible for CE  marking under this Regulation and 
excluded from the scope of Regulation  (EC) No  1107/2009 of the European 
Parliament and of the Council21. Regulation (EC) No 1107/2009 should therefore be 
amended acco rdingly.  
(16) Products with one or more functions, one of which is covered by the scope of 
Regulation  (EC) No  1107/2009, should remain under the control tailored for such 
products and provided for by that Regulation. Where such products also have the 
funct ion of a fertilising product, it would be misleading to provide for their 
CE marking under this Regulation, since the making available on the market of a plant 
protection product is contingent on a product authorisation valid in the Member State 
in questio n. Therefore, such products should be excluded from the scope of this 
Regulation.  
(17) This Regulation should not prevent the application of existing Union legislation 
relating to aspects of protection of health, safety and the environment not covered by 
this Regulation. This Regulation should therefore apply without prejudice to Council 
Directive  86/278/EEC22, Council Directive  89/391/EEC23, Regulation  (EC) 
No 1907/2006 of the European Parliament and of the Council24, Regulation  (EC) 
No 1272/2008 of the Euro pean Parliament and of the Council25, Commission 
Regulation  (EC) No 1881/200626, Council Directive 2000/29/EC27, Regulation  (EU) 
No 98/2013 of the European Parliament and of the Council28, and Regulation  (EU) 
No 1143/2014 of the European Parliament and of the Council29.  
                                                 
21 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repe aling Council Directives 
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p.  1). 
22 Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular 
of the soil, when sewage sludge is used in agriculture (OJ L 181, 4.7.19 86, p. 6).  
23 Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage 
improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).  
24 Regulation (EC) No 1907/2006 of the European Parliament and of th e Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 
(OJ L 396, 30.12.2006, p. 1).  
25 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures (OJ L 353, 31.12.2008, p. 1).  
26 Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain 
contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5).  
27 Council  Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the 
Community of organisms harmful to plants or plant products and against their spread within the 
Community (OJ L 169, 10.7.2000, p. 1).  
28 Regulation (EU) No 98/2013 of the European Parliament and of the Council of 15 January 2013 on the 
marketing and use of explosives precursors (OJ L 39, 9.2.2013, p. 1).  
29 Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on 
the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 
4.11.2014, p.  35). EN 15   EN (18) Where a CE  marked fertilising product contains a substance or mixture within the 
meaning of Regulation (EC) No  1907/2006, the safety of its constituent substances for 
the intended use should be established through registration pursuant to t hat Regulation. 
The information requirements should ensure that the safety of the intended use of the 
CE marked fertilising product is demonstrated in a manner comparable to that 
achieved through other regulatory regimes for products intended for use on ar able soil 
or crops, notably Member States' national fertiliser legislation and Regulation  (EC) 
No 1107/2009. Therefore, where the actual quantities placed on the market are lower 
than 10 tonnes per company per year, the information requirements determined by 
Regulation (EC) No 1907/2006 for the registration of substances in quantities of 10  to 
100 tonnes should exceptionally apply as a condition for making available pursuant to 
this Regulation.  
(19) Where the actual quantities of substances in CE  marked fer tilising products regulated 
by this Regulation are higher than 100  tonnes, the additional information requirements 
laid down in Regulation  (EC) No  1907/2006 should apply directly by virtue of that 
Regulation. The application of the other provisions of Regu lation  (EC) No  1907/2006 
should also remain unaffected by this Regulation.  
(20) A blend of different CE  marked fertilising products, each of which has been subject to 
a successful assessment of conformity with the applicable requirements for that 
material,  can itself be expected to be suitable for use as a CE  marked fertilising 
product, subject only to certain additional requirements warranted by the blending. 
Therefore, in order to avoid an unnecessary administrative burden, such blends should 
belong to a separate category, for which the conformity assessment should be limited 
to the additional requirements warranted by the blending.  
(21) Economic operators should be responsible for the compliance of CE  marked fertilising 
products with this Regulation, in r elation to their respective roles in the supply chain, 
so as to ensure a high level of protection of the aspects of public interest covered by 
this Regulation, and also to guarantee fair competition on the internal market.  
(22) It is necessary to provide f or a clear and proportionate distribution of obligations 
which correspond to the role of each economic operator in the supply and distribution 
chain.  
(23) The manufacturer, having detailed knowledge of the design and production process, is 
best placed to c arry out the conformity assessment procedure. Conformity assessment 
of CE  marked fertilising products should therefore remain solely the obligation of the 
manufacturer.  
(24) It is necessary to ensure that CE  marked fertilising products from third countries  that 
enter the internal market comply with this Regulation, and in particular that the 
appropriate conformity assessment procedures have been carried out by manufacturers 
with regard to those fertilising products. Provision should therefore be made for 
importers to make sure that CE  marked fertilising products which they place on the 
market comply with the requirements of this Regulation and that they do not place on 
the market CE  marked fertilising products which do not comply with such 
requirements or pr esent a risk to human, animal or plant health, safety or the 
environment. Provision should also be made for such importers to make sure that 
conformity assessment procedures have been carried out and that marking of 
CE marked fertilising products and docum entation drawn up by manufacturers are 
available for inspection by the competent national authorities.  EN 16   EN (25) When placing a CE  marked fertilising product on the market, the importer should 
indicate on the packaging of the fertilising product his or her name , registered trade 
name or registered trade mark and the postal address at which he or she can be 
contacted, in order to enable market surveillance.  
(26) Since the distributor makes a CE  marked fertilising product available on the market 
after it has been placed on the market by the manufacturer or the importer, he or she 
should act with due care to ensure that his or her handling of the fertilising product 
does not adversely affect the compliance of that product with this Regulation.  
(27) An economic opera tor who either places a CE  marked fertilising product on the market 
under his or her own name or trade mark or modifies a CE  marked fertilising product 
in such a way that compliance with the provisions of this Regulation may be affected 
should be considere d to be the manufacturer and should assume the obligations of the 
manufacturer.  
(28) Since distributors and importers are close to the market place, they should be involved 
in market surveillance tasks carried out by competent national authorities, and sho uld 
be required to participate actively and provide those authorities with all necessary 
information relating to the CE  marked fertilising product.  
(29) Ensuring traceability of a CE  marked fertilising product throughout the whole supply 
chain helps to mak e market surveillance simpler and more efficient. An efficient 
traceability system facilitates market surveillance authorities’ task of tracing economic 
operators who made non -compliant CE  marked fertilising products available on the 
market. When keeping t he information required for the identification of other 
economic operators, economic operators should not be required to update such 
information in respect of other economic operators who have either supplied them 
with a CE  marked fertilising product or to  whom they have supplied a CE  marked 
fertilising product, since such updated information is normally not available to them.  
(30) In order to facilitate the assessment of conformity with safety and quality requirements 
it is necessary to provide for a presu mption of conformity for CE  marked fertilising 
products which are in conformity with harmonised standards that are adopted in 
accordance with Regulation  (EU) No  1025/2012 of the European Parliament and of 
the Council30. 
(31) Where harmonised standards have not been adopted, or do not with sufficient detail 
cover all elements of the quality and safety requirements laid down in this Regulation, 
uniform conditions for implementing those requirements may be needed. The 
Commission should therefore be empowered to  adopt implementing acts setting out 
those conditions in common specifications. For reasons of legal certainty, it should be 
clarified that CE  marked fertilising products must comply with such specifications 
even if they are considered to be in conformity with harmonised standards.  
(32) In order to enable the economic operators to demonstrate and the competent 
authorities to verify that CE  marked fertilising products made available on the market 
comply with the requirements, it is necessary to provide for c onformity assessment 
                                                 
30 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on 
European standardisation, amending Council Directives 8 9/686/EEC and 93/15/EEC and Directives 
94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 
2009/105/EC of the European Parliament and of the Council and repealing Council Decision 
87/95/EEC and Decision No 1673/2006/EC o f the European Parliament and of the Council (OJ L 316, 
14.11.2012, p. 12).  EN 17   EN procedures. Decision No 768/2008/EC establishes modules for conformity assessment 
procedures, from the least to the most stringent, in proportion to the level of risk 
involved and the level of safety required. In order to ensure inter -sectoral coherence 
and to avoid ad -hoc variants, conformity assessment procedures should be chosen 
from among those modules. However, it is necessary to adapt those modules in order 
to reflect specific aspects of fertilising products. In particular, it is necessary to 
reinforce the quality systems and the involvement of notified bodies for the conformity 
assessment of certain CE  marked fertilising products derived from recovered waste.  
(33) In order to ensure that CE  marked ammonium nitrate fertilisers of h igh nitrogen 
content do not endanger safety, and that such fertilisers are not used for purposes other 
than those for which they are intended, for example as explosives, such fertilisers 
should be subject to specific requirements relating to detonation res istance testing and 
to traceability.  
(34) To ensure effective access to information for market surveillance purposes, 
information regarding conformity with all Union acts applicable to CE marked 
fertilising products should be given in the form of a single EU declaration of 
conformity. In order to reduce the administrative burden on economic operators, that 
single EU declaration of conformity may be a dossier made up of relevant individual 
declarations of conformity.  
(35) The CE marking, indicating the confo rmity of a fertilising product, is the visible 
consequence of a whole process comprising conformity assessment in a broad sense. 
General principles governing the CE marking and its relationship to other markings 
are set out in Regulation (EC) No 765/2008. Specific rules governing the affixing of 
the CE marking in the case of fertilising products should be laid down.  
(36) Certain conformity assessment procedures set out in this Regulation require the 
intervention of conformity assessment bodies, which are n otified by the Member 
States to the Commission.  
(37) It is essential that all notified bodies perform their functions to the same level and 
under conditions of fair competition. That requires the setting of obligatory 
requirements for conformity assessment  bodies wishing to be notified in order to 
provide conformity assessment services.  
(38) If a conformity assessment body demonstrates conformity with the criteria laid down 
in harmonised standards it should be presumed to comply with the corresponding 
requirements set out in this Regulation.  
(39) In order to ensure a consistent level of quality in the performance of conformity 
assessment of CE marked fertilising products, it is also necessary to set requirements 
for notifying authorities and other bodie s involved in the assessment, notification and 
monitoring of notified bodies.  
(40) The system set out in this Regulation should be complemented by the accreditation 
system provided for in Regulation (EC) No 765/2008. Since accreditation is an 
essential means of verifying the competence of conformity assessment bodies, it 
should also be used for the purposes of notification.  
(41) Due to the variable nature of certain fertilising product component materials, and the 
potentially irreversible nature of some of the damages to which soil and crop exposure 
to impurities could lead, transparent accreditation as provided for in Regulation  (EC) 
No 765/2008, ensuring the necessary level of confidence in certificates of conformity EN 18   EN of CE marked fertilising products co ntaining such components, should be the only 
means of demonstrating the technical competence of conformity assessment bodies.  
(42) Conformity assessment bodies frequently subcontract parts of their activities linked to 
the assessment of conformity or have recourse to a subsidiary. In order to safeguard 
the level of protection required for CE marked fertilising products to be placed on the 
market, it is essential that conformity assessment subcontractors and subsidiaries fulfil 
the same requirements as notif ied bodies in relation to the performance of conformity 
assessment tasks. Therefore, it is important that the assessment of the competence and 
the performance of bodies to be notified and the monitoring of bodies already notified 
cover also activities carr ied out by subcontractors and subsidiaries.  
(43) It is necessary to provide for an efficient and transparent notification procedure and, in 
particular, to adapt it to new technologies so as to enable online notification.  
(44) Since the services offered by notified bodies may relate to CE marked fertilising 
products made available on the market throughout the Union, it is appropriate to give 
the other Member States and the Commission the opportunity to raise objections 
concerning a notified body. It is there fore important to provide for a period during 
which any doubts or concerns as to the competence of conformity assessment bodies 
can be clarified before they start operating as notified bodies.  
(45) In the interest of easing market access, it is crucial tha t notified bodies apply the 
conformity assessment procedures without creating unnecessary burdens for economic 
operators. For the same reason, and to ensure equal treatment of economic operators, 
consistency in the technical application of the conformity a ssessment procedures needs 
to be ensured. That can best be achieved through appropriate coordination and 
cooperation between notified bodies.  
(46) In order to ensure legal certainty, it is necessary to clarify that rules on internal market 
surveillance and  control of products entering the internal market provided for in 
Regulation (EC) No 765/2008 apply to CE marked fertilising products covered by this 
Regulation. This Regulation should not prevent Member States from choosing the 
competent authorities to ca rry out those tasks.  
(47) CE-marked fertilising products should be placed on the market only if they are 
sufficiently effective and do not present unacceptable risks to human, animal or plant 
health, to safety or to the environment when properly stored an d used for their 
intended purpose, and under conditions of use which can be reasonably foreseen, that 
is when such use could result from lawful and readily predictable human behaviour. 
Therefore, requirements for safety and quality, as well as appropriate control 
mechanisms, should be established. Furthermore, the intended use of CE  marked 
fertilising products should not lead to food or feed becoming unsafe.  
(48) Regulation  (EC) No  2003/2003 provides for a safeguard procedure allowing the 
Commission to exa mine the justification for a measure taken by a Member State 
against EC fertilisers considered to constitute a risk. In order to increase transparency 
and to reduce processing time, it is necessary to improve the existing safeguard 
procedure, with the view  to making it more efficient and drawing on the expertise 
available in Member States.  
(49) The existing system should be supplemented by a procedure under which interested 
parties are informed of measures intended to be taken with regard to CE  marked 
fertilising products presenting an unacceptable risk to human, animal or plant health, 
to safety or to the environment. It should also allow market surveillance authorities, in EN 19   EN cooperation with the relevant economic operators, to act at an early stage in respec t of 
such fertilising products.  
(50) Where the Member States and the Commission agree as to the justification of a 
measure taken by a Member State, further involvement of the Commission should be 
required only where non -compliance can be attributed to shor tcomings of a 
harmonised standard, in which case the procedure of formal objection to harmonised 
standards laid down in Regulation  (EU) No  1025/2012 should apply.   
(51) In order to ensure uniform conditions for the implementation of this Regulation, 
implem enting powers should be conferred on the Commission. Those powers should 
be exercised in accordance with Regulation (EU) No 182/2011 of the European 
Parliament and of the Council31. 
(52) The advisory procedure should be used for the adoption of implementing  acts 
requiring the notifying Member State to take the necessary corrective measures in 
respect of notified bodies that do not meet or no longer meet the requirements for their 
notification, since such acts do not fall within the ambit of Article  2(2) of 
Regulation  (EU) No 182/2011.  
(53) The examination procedure should be used for the adoption of implementing acts with 
respect to compliant CE  marked fertilising products which present an unacceptable 
risk to human, animal or plant health, to safety or to th e environment, since such acts 
fall within the ambit of Article  2(2) of Regulation  (EU) No 182/2011. For the same 
reason, it should also be used for the adoption, amendment or repeal of common 
specifications.  
(54) The Commission should, by means of impleme nting acts, determine whether measures 
taken by Member States in respect of non -compliant CE  marked fertilising products 
are justified or not. Since those acts will relate to the question whether national 
measures are justified, there is no need for the ac ts to be subject to control by the 
Member States.  
(55) Promising technical progress is being made in the field of recycling of waste, such as 
phosphorus recycling from sewage sludge, and fertilising product production from 
animal by -products, such as bioch ar. It should be possible for products containing or 
consisting of such materials to access the internal market without unnecessary delay 
when the manufacturing processes have been scientifically analysed and process 
requirements have been established at U nion level. For that purpose, the power to 
adopt acts in accordance with Article 290 of the Treaty on the Functioning of the 
European Union should be delegated to the Commission in respect of defining larger 
or additional categories of CE  marked fertilisin g products or component materials 
eligible for use in the production of such products. For animal by -products, component 
material categories should be expanded or added only to the extent an end point in the 
manufacturing chain has been determined in accor dance with the procedures laid down 
in Regulation (EC) No  1069/2009, since animal by -products for which no such end 
point has been determined are in any event excluded from the scope of this 
Regulation.  
(56) Furthermore, it should be possible to react imme diately to new findings regarding the 
conditions for CE  marked fertilising products to be sufficiently effective and to new 
                                                 
31 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 
laying down the rules and general principles concerning mechanisms for control by Me mber States of 
the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p.13).  EN 20   EN risk assessments regarding human, animal or plant health, safety or the environment. 
For that purpose, the power to adopt acts in ac cordance with Article 290 of the Treaty 
should be delegated to the Commission to amend the requirements applicable to 
various categories of CE  marked fertilising products.  
(57) In exercising those powers, it is of particular importance that the Commission carry 
out appropriate consultations during its preparatory work, including at expert level. 
The Commission, when preparing and drawing up delegated acts, should ensure a 
simultaneous, timely and appropriate transmission of relevant documents to the 
Europea n Parliament and to the Council.  
(58) Member States should lay down rules on penalties applicable to infringements of this 
Regulation and ensure that those rules are enforced. The penalties provided for should 
be effective, proportionate and dissuasive.  
(59) It is necessary to provide for transitional arrangements that allow the making available 
on the market of EC fertilisers that have been placed on the market in accordance with 
Regulation  (EC) No  2003/2003 before the date of application of this Regulatio n 
without those products having to comply with further product requirements. 
Distributors should therefore be able to supply EC fertilisers that have been placed on 
the market, namely stock that is already in the distribution chain, before the date of 
application of this Regulation.  
(60) It is necessary to provide for sufficient time for economic operators to comply with 
their obligations under this Regulation, and for Member States to set up the 
administrative infrastructure necessary for its application. The application should 
therefore be deferred to a date where those preparations can reasonably be finalised.  
(61) Since the objective of this Regulation, namely to guarantee the functioning of the 
internal market while ensuring that CE  marked fertilising p roducts on the market fulfil 
the requirements providing for a high level of protection of human, animal, and plant 
health, safety and the environment, cannot be sufficiently achieved by the Member 
States but can rather, by reason of its scale and effects, be better achieved at Union 
level, the Union may adopt measures, in accordance with the principle of subsidiarity 
as set out in Article 5 of the Treaty on European Union. In accordance with the 
principle of proportionality, as set out in that Article, this  Regulation does not go 
beyond what is necessary in order to achieve that objective,  
HAVE ADOPTED THIS REGULATION:  
CHAPTER 1  
GENERAL PROVISIONS  
Article 1  
Scope  
1. This Regulation shall apply to CE  marked fertilising products.  
However, this Regulation shall  not apply to the following products:  
(a) animal by -products which are subject to the requirements of Regulation (EC) 
No 1069/2009,  
(b) plant protection products covered by the scope of Regulation  (EC) 
No 1107/2009.  EN 21   EN 2. This Regulation shall not affect the application of the following acts :  
(a) Directive  86/278/EEC;  
(b) Directive  89/391/EEC;  
(c) Regulation (EC) No 1907/2006;  
(d) Regulation (EC) No 1272/2008;  
(e) Regulation (EC) No 1881/2006;  
(f) Directive 2000/29/EC;  
(g) Regulation (EU) No 98/2013;  
(h) Regulation  (EU) No  1143/2014.  
Artic le 2 
Definitions  
For the purposes of this Regulation, the following definitions shall apply:  
(1) ‘fertilising product’ means a substance, mixture, micro -organism or any other 
material, applied or intended to be applied, either on its own or mixed with 
another material, on plants or their rhizosphere for the purpose of providing 
plants with nutrient or improving their nutrition efficiency;  
(2) ‘CE marked fertilising product’ means a fertilising product which is 
CE marked when made available on the market;  
(3) ‘substance ’ means a substance within the meaning of Article 3(1) of 
Regulation (EC) No 1907/2006;  
(4) ‘mixture’ means a mixture within the meaning of Article 3(2) of 
Regulation  (EC) No  1907/2006;  
(5) 'micro -organism' means a micro -organism within the meaning of Article  3(15) 
of Regulation  (EC) No  1107/2009;  
(6) ‘making available on the market’ means any supply of a CE  marked fertilising 
product for distribution or use on the Union market in the course of a 
commercial activity, whether in return for payment or free of charge;  
(7) ‘placing on the market’ means the first making available of a CE  marked 
fertilising product on the Union market;  
(8) ‘manufacturer’ means a natural or legal person who manufactures a CE  marked 
fertilising product or has a CE  marked fertilising product designed or  
manufactured, and markets that fertilising product under his or her name or 
trademark;  
(9) ‘authorised representative’ means a natural or legal person established within 
the Union who has received a written mandate from a manufacturer to act on 
his or her beh alf in relation to specified tasks;  
(10) ‘importer’ means any natural or legal person established within the Union who 
places a CE  marked fertilising product from a third country on the Union 
market;  EN 22   EN (11) ‘distributor’ means any natural or legal person in the supply  chain, other than 
the manufacturer or the importer, who makes a CE  marked fertilising product 
available on the market;  
(12) ‘economic operators’ means manufacturers, authorised representatives, 
importers and distributors;  
(13) 'technical specification' means a document that prescribes technical 
requirements to be fulfilled by a CE  marked fertilising product;  
(14) ‘harmonised standard’ means harmonised standard as defined in Article 2(1)(c) 
of Regulation (EU) No 1025/2012;  
(15) ‘accreditation’ means accreditation as define d in Article 2(10) of 
Regulation  (EC) No  765/2008;  
(16) ‘national accreditation body’ means national accreditation body as defined in 
Article  2(11) of Regulation (EC) No 765/2008;  
(17) ‘conformity assessment’ means the process demonstrating whether the 
requirements  provided in this Regulation relating to a CE  marked fertilising 
product have been fulfilled;  
(18) ‘conformity assessment body’ means a body that performs conformity 
assessment activities including testing, certification and inspection;  
(19) ‘recall’ means any measu re aimed at achieving the return of a CE  marked 
fertilising product that has already been made available to the end -user;  
(20) ‘withdrawal’ means any measure aimed at preventing a CE  marked fertilising 
product in the supply chain from being made available on th e market;  
(21) ‘CE marking’ means a marking by which the manufacturer indicates that the 
fertilising product is in conformity with the applicable requirements set out in 
Union harmonisation legislation providing for its affixing;  
(22) ‘Union harmonisation legislatio n’ means any Union legislation harmonising 
the conditions for the marketing of products.  
Article 3  
Free movement  
Member States shall not impede the making available on the market of CE marked 
fertilising products which comply with this Regulation.  
Article 4 
Product requirements  
1. A CE  marked fertilising product shall  
(a) meet the requirements set out in Annex  I for the relevant product function 
category;  
(b) meet the requirements set out in Annex  II for the relevant component material 
category or categories;  
(c) be labelled in accordance with the labelling requirements set out in Annex  III. 
2. For any aspects not covered by Annex I or II, CE marked fertilising products shall 
meet the requirement that their use, as specified in the use instructions, does not lead EN 23   EN to food or feed of plant origin becoming unsafe within the meaning of Articles  14 
and 15 of Regulation (EC) No 178/2002, respectively.  
Article 5  
Making available on the market  
CE marked fertilising products may be made available on the market only if they 
satisfy the requirements of the present Regulation.  
CHAPTER 2  
OBLIGATIONS OF ECONO MIC OPERATORS  
Article 6  
Obligations of manufacturers  
1. When placing CE  marked fertilising products on the market, manufacturers shall 
ensure that they have been designed and man ufactured in accordance with the 
requirements set out in Annex I for the relevant product function category and the 
requirements set out in Annex II for the relevant component material category or 
categories.  
2. Before placing CE  marked fertilising product s on the market, manufacturers shall 
draw up the technical documentation and carry out the relevant conformity 
assessment procedure referred to in Article 14, or have it carried out. Where 
compliance of such a fertilising product with the applicable requir ements laid down 
in this Regulation has been demonstrated by that procedure, manufacturers shall affix 
the CE  marking, draw up an EU declaration of conformity and ensure that the 
declaration accompanies the fertilising product when placed on the market.  
3. Manufacturers shall keep the technical documentation and the EU declaration of 
conformity for 10 years after the CE  marked fertilising product covered by those 
documents has been placed on the market.  
4. Manufacturers shall ensure that procedures are in place for CE  marked fertilising 
products that are part of a series production to remain in conformity with this 
Regulation. Changes in production method or characteristics of those fertilising 
products and changes in the harmonised standards, common specif ications referred to 
in Article  13 or other technical specifications by reference to which conformity of a 
CE marked fertilising product is declared shall be adequately taken into account.  
When deemed appropriate with regard to the performance of, or the risks presented 
by, a CE  marked fertilising product, manufacturers shall carry out sample testing of 
such fertilising products made available on the market, investigate, and, if necessary, 
keep a register  of complaints, of non -conforming CE  marked fertilis ing products and 
recalls of such products, and shall keep distributors informed of any such monitoring.  
5. Manufacturers shall ensure that the packaging of the CE  marked fertilising products 
which they have placed on the market bears a type, batch or seri al number or other 
element allowing their identification or, where the fertilising products are supplied 
without packaging, that the required information is provided in a document 
accompanying each fertilising product.  
6. Manufacturers shall indicate their  name, registered trade name or registered trade 
mark and the postal address at which they can be contacted on the packaging of the EN 24   EN CE marked fertilising product or, where the fertilising product is supplied without 
packaging, in a document accompanying th e fertilising product. The postal address 
shall indicate a single point at which the manufacturer can be contacted. The contact 
details shall be in a language easily understood by end -users and market surveillance 
authorities.  
7. Manufacturers shall ensure  that CE  marked fertilising products are labelled in 
accordance with Annex  III, or where the fertilising product is supplied without 
packaging, that the labelling statements are provided in a document accompanying 
the fertilising product and accessible for  inspection purposes when the product is 
placed on the market. The labelling statement shall be in a language which can be 
easily understood by end -users, as determined by the Member State concerned, and 
shall be clear, understandable and intelligible.  
8. Manufacturers who consider or have reason to believe that a CE  marked fertilising 
product which they have placed on the market is not in conformity with this 
Regulation shall immediately take the corrective measures necessary to bring that 
fertilising prod uct into conformity, to withdraw it or to recall it, if appropriate.  
Furthermore, where manufacturers consider or have reason to believe that 
CE marked fertilising products which they have placed on the market present an 
unacceptable risk to human, animal  or plant health, to safety or to the environment, 
they shall immediately inform the competent national authorities of the Member 
States in which they made the fertilising products available on the market to that 
effect, giving details, in particular, of a ny non -compliance and of any corrective 
measures taken.  
9. Manufacturers shall, further to a reasoned request from a competent national 
authority, provide it with all the information and documentation, in paper or 
electronic form, necessary to demonstrate the conformity of the CE  marked 
fertilising product with this Regulation, in a language which can be easily understood 
by that authority. They shall cooperate with that authority, at its request, on any 
action taken to eliminate the risks posed by CE  marke d fertilising products which 
they have placed on the market.  
10. The manufacturer shall submit to the competent authority of the Member State of 
destination a report of the detonation resistance test prescribed in Annex IV for the 
following CE  marked ferti lising products:  
(a) straight or compound solid inorganic macronutrient ammonium nitrate 
fertilisers of high nitrogen content, as specified in product function 
category  1(C)(I)(a)(i -ii)(A) in  Annex  I; 
(b) fertilising product blends, as specified in product functio n category  7 in 
Annex  I, containing a fertiliser referred to in point  (a). 
The report shall be submitted at least five days in advance of placing those products 
on the market.  
Article 7  
Authorised representative  
1. A manufacturer may, by a written mandate,  appoint an authorised representative.  EN 25   EN The obligations laid down in Article 6(1) and the obligation to draw up technical 
documentation referred to in Article 6(2) shall not form part of the authorised 
representative's mandate.  
2. An authorised representat ive shall perform the tasks specified in the mandate 
received from the manufacturer. The mandate shall allow the authorised 
representative to do at least the following:  
(a) keep the EU declaration of conformity and the technical documentation at the 
disposal o f national market surveillance authorities for 10 years after the 
CE marked fertilising product covered by those documents has been placed on 
the market;  
(b) further to a reasoned request from a competent national authority, provide that 
authority with all the  information and documentation necessary to demonstrate 
the conformity of a CE  marked fertilising product;  
(c) cooperate with the competent national authorities, at their request, on any 
action taken to eliminate the risks posed by CE  marked fertilising produc ts 
covered by the authorised representative's mandate.  
Article 8  
Obligations of importers  
1. Importers shall place only compliant CE  marked fertilising products on the market.  
2. Before placing a CE  marked fertilising product on the market importers shall ensure 
that the appropriate conformity assessment procedure referred to in Article 14 has 
been carried out by the manufacturer. They shall ensure that the manufacturer has 
drawn up the technical documentation, that the CE  marked fertilising product is 
accompanied by the EU declaration of conformity and the required documents, and 
that the manufacturer has complied with the requirements set out in Article 6(5) 
and (6). Where an importer considers or has reason to believe that a CE  marked 
fertilising product is not in conformity with the applicable requirements set out in 
Annex I, Annex II or Annex  III, he or she shall not place the fertilising product on 
the market until it has been brought into conformity. Furthermore, where the 
CE marked fertilising product  presents an unacceptable risk to human, animal or 
plant health, to safety or to the environment, the importer shall inform the 
manufacturer and the market surveillance authorities to that effect.  
3. Importers shall indicate their name, registered trade name or registered trade mark 
and the postal address at which they can be contacted on the packaging of the 
CE marked fertilising product or, where the CE  marked fertilising product is supplied 
without packaging, in a document accompanying the fertilising product. The contact 
details shall be in a language easily understood by end -users and market surveillance 
authorities.  
4. Importers shall ensure that the CE  marked fertilising product is labelled in 
accordance with Annex  III in a language which can be eas ily understood by end -
users, as determined by the Member State concerned.  
5. Importers shall ensure that, while a CE  marked fertilising product is under their 
responsibility, its storage or transport conditions do not jeopardise its compliance 
with the saf ety and quality requirements set out in Annex I or with the labelling 
requirements set out in Annex  III. EN 26   EN 6. When deemed appropriate with regard to the performance of or the risks presented 
by a CE  marked fertilising product, importers shall carry out sampl e testing of such 
fertilising products made available on the market, investigate, and, if necessary, keep 
a register of complaints, of non -conforming CE  marked fertilising products and 
recalls of such products, and shall keep distributors informed of any s uch monitoring.  
7. Importers who consider or have reason to believe that a CE  marked fertilising 
product which they have placed on the market is not in conformity with this 
Regulation shall immediately take the corrective measures necessary to bring that 
fertilising product into conformity, to withdraw it or to recall it, if appropriate.  
Furthermore, where importers consider or have reason to believe that CE  marked 
fertilising products which they have placed on the market present an unacceptable 
risk to h uman, animal or plant health, to safety or to the environment, they shall 
immediately inform the competent national authorities of the Member States in 
which they made the fertilising product available on the market to that effect, giving 
details, in parti cular, of any non -compliance and of any corrective measures taken.  
8. Importers shall, for 10 years after the CE  marked fertilising product has been placed 
on the market, keep a copy of the EU declaration of conformity at the disposal of the 
market surveil lance authorities and ensure that the technical documentation can be 
made available to those authorities, upon request.  
9. Importers shall, further to a reasoned request from a competent national authority, 
provide it with all the information and documenta tion, in paper or electronic form, 
necessary to demonstrate the conformity of the CE  marked fertilising product in a 
language which can be easily understood by that authority. They shall cooperate with 
that authority, at its request, on any action taken to  eliminate the risks posed by 
CE marked fertilising products which they have placed on the market.  
10. The importer shall submit to the competent authority of the Member State of 
destination a report of the detonation resistance test prescribed in Annex IV  for the 
following CE  marked fertilising products:  
(a) straight or compound solid inorganic macronutrient ammonium nitrate 
fertilisers of high nitrogen content, as specified in product function 
category  1(C)(I)(a)(i -ii)(A) in  Annex  I; 
(b) fertilising product blend s, as specified in product function category  7 in 
Annex  I, containing a fertiliser referred to in point  (a). 
The report shall be submitted at least five days in advance of placing those products 
on the market.  
Article 9  
Obligations of distributors  
1. When making a CE  marked fertilising product available on the market distributors 
shall act with due care in relation to the requirements of this Regulation.  
2. Before making a CE  marked fertilising product available on the market distributors 
shall verify that it is accompanied by the EU declaration of conformity and by the 
required documents, that it is labelled in accordance with Annex III in a language 
which can be easily understood by end -users in the Member State in which the 
CE marked fertilising product i s to be made available on the market, and that the EN 27   EN manufacturer and the importer have complied with the requirements set out in 
Article  6(5) and (6) and Article  8(3) respectively.  
Where a distributor considers or has reason to believe that a CE  marked fer tilising 
product is not in conformity with the applicable requirements set out in Annex I, 
Annex II or Annex  III, he or she shall not make the fertilising product available on 
the market until it has been brought into conformity. Furthermore, where the 
CE marked fertilising product presents an unacceptable risk to human, animal or 
plant health, to safety or to the environment, the distributor shall inform the 
manufacturer or the importer to that effect as well as the market surveillance 
authorities.  
3. Distributors shall ensure that, while a CE  marked fertilising product is under their 
responsibility, its storage or transport conditions do not jeopardise its compliance 
with the safety and quality requirements set out in Annex I or the labelling 
requirements set out in Annex  III. 
4. Distributors who consider or have reason to believe that a CE  marked fertilising 
product which they have made available on the market is not in conformity with this 
Regulation shall make sure that the corrective measures necessary to bring that 
fertilising product into conformity, to withdraw it or to recall it, if appropriate, are 
taken.  
Furthermore, where distributors consider or have reason to believe that CE  marked 
fertilising products which they have made available on the mark et presents an 
unacceptable risk to human, animal or plant health, to safety or to the environment, 
they shall immediately inform the competent national authorities of the Member 
States in which they made the CE  marked fertilising product available on the market 
to that effect, giving details, in particular, of any non -compliance and of any 
corrective measures taken.  
5. Distributors shall, further to a reasoned request from a competent national authority, 
provide it with all the information and documentatio n, in paper or electronic form, 
necessary to demonstrate the conformity of the CE  marked fertilising product. They 
shall cooperate with that authority, at its request, on any action taken to eliminate the 
risks posed by CE  marked fertilising products which  they have made available on the 
market.  
Article 10  
Cases in which obligations of manufacturers apply to importers and distributors  
An importer or distributor shall be considered a manufacturer for the purposes of this 
Regulation, and shall be subject to t he obligations of the manufacturer under 
Article  6, where he or she places a CE  marked fertilising product on the market 
under his or her name or trademark or modifies a CE  marked fertilising product 
already placed on the market in such a way that complian ce with this Regulation may 
be affected.  
Article 11  
Identification of economic operators  
1. Economic operators shall, on request, identify the following to the market 
surveillance authorities:  EN 28   EN (a) any economic operator who has supplied them with a CE  marked fe rtilising 
product;  
(b) any economic operator to whom they have supplied a CE  marked fertilising 
product.  
2. The economic operators shall be able to present the information referred to in the 
first paragraph for 10 years after they have been supplied with the  CE marked 
fertilising product and for 10 years after they have supplied the CE  marked fertilising 
product.  
CHAPTER 3  
CONFORMITY OF CE  MARKED FERTILISING P RODUCTS  
Article 12  
Presumption of conformity  
Without prejudice to the common specifications referred to in Article 13, CE  marked 
fertilising products which are in conformity with harmonised standards or parts 
thereof the references of which have been published in the Official Journal of the 
European Union  shall be presumed to be in conformity with the req uirements set out 
in Annexes  I, II and III covered by those standards or parts thereof.  
Article 13  
Common specifications  
The Commission may adopt implementing acts laying down common specifications, 
the compliance with which shall ensure conformity with the requirements set out in 
Annexes  I, II and III covered by those specifications or parts thereof. Those 
implementing acts shall be adopted in accordance with the examination procedure 
referred to in Article  41(3).  
Article 14  
Conformity assessment procedu res 
1. Conformity assessment of a CE  marked fertilising product with the requirements in 
this Regulation shall be carried out by applying the conformity assessment procedure 
specified in Annex IV.  
2. Records and correspondence relating to conformity assessment procedures shall be 
drawn up in the official language(s) of the Member State where the notified body 
carrying out the conformity assessment procedures is established, or in a language 
accepted by that body.  
Article 15  
EU declaration of conformit y 
1. The EU declaration of conformity shall state that the fulfilment of the requirements 
set out in Annexes I, II and III has been demonstrated.  
2. The EU declaration of conformity shall have the model structure set out in Annex  V, 
shall contain the eleme nts specified in the relevant modules set out in Annex IV and 
shall be continuously updated. It shall be translated into the language or languages EN 29   EN required by the Member State in which the CE  marked fertilising product is placed or 
made available on the ma rket. 
3. Where a CE  marked fertilising product is subject to more than one Union act 
requiring an EU declaration of conformity, a single EU declaration of conformity 
shall be drawn up in respect of all such Union acts. That declaration shall state the 
Unio n acts concerned and their publication references. It may be a dossier made up 
of relevant individual declarations of conformity.  
4. By drawing up the EU declaration of conformity, the manufacturer shall assume 
responsibility for the compliance of the CE  marked fertilising product with the 
requirements laid down in this Regulation.  
Article 16  
General principles of CE marking  
The CE marking shall be subject to the general principles set out in Article 30 of 
Regulation  (EC) No 765/2008.  
Article 17  
Rules and conditions for affixing the CE marking  
1. The CE marking shall be affixed visibly, legibly and indelibly to the accompanying 
documents and, where the CE  marked fertilising product is supplied in a packaged 
form, to the packaging.  
2. The CE marking shall b e affixed before the CE  marked fertilising product is placed 
on the market.  
3. The CE marking shall be followed by the identification number of the notified body 
involved in the conformity assessment referred to in Annex  IV, Module D1.  
The identification n umber of the notified body shall be affixed by the body itself or, 
under its instructions, by the manufacturer or his or her authorised representative.  
4. Member States shall build upon existing mechanisms to ensure correct application of 
the regime govern ing the CE marking and shall take appropriate action in the event 
of improper use of that marking.  
Article 18  
End-of-waste status  
A CE  marked fertilising product that has undergone a recovery operation and 
complies with the requirements laid down in this R egulation shall be considered to 
comply with the conditions laid down in Article  6(1) of Directive  2008/98/EC and 
shall, therefore, be considered as having ceased to be waste.  EN 30   EN CHAPTER 4  
NOTIFICATION OF CONF ORMITY ASSESSMENT BO DIES  
Article 19  
Notification  
Member States shall notify the Commission and the other Member States of bodies 
authorised to carry out third -party conformity assessment tasks under this 
Regulation.  
Article 20  
Notifying authorities  
1. Member States shall designate a notifying authority t hat shall be responsible for 
setting up and carrying out the necessary procedures for the assessment and 
notification of conformity assessment bodies and the monitoring of notified bodies, 
including compliance with Article 25.  
2. Member States may decide t hat the assessment and monitoring referred to in 
paragraph 1 shall be carried out by a national accreditation body within the meaning 
of and in accordance with Regulation  (EC) No 765/2008.  
3. Where the notifying authority delegates or otherwise entrusts th e assessment, 
notification or monitoring referred to in paragraph 1 to a body which is not a 
governmental entity, that body shall be a legal entity and shall comply mutatis 
mutandis  with the requirements laid down in Article  21. In addition it shall have 
arrangements to cover liabilities arising out of its activities.  
4. The notifying authority shall take full responsibility for the tasks performed by the 
body referred to in paragraph 3.  
Article 21  
Requirements relating to notifying authorities  
1. A notifying authority shall be established in such a way that no conflict of interest 
with conformity assessment bodies occurs.  
2. A notifying authority shall be organised and operated so as to safeguard the 
objectivity and impartiality of its activities.  
3. A notifying authority shall be organised in such a way that each decision relating to 
notification of a conformity assessment body is taken by competent persons different 
from those who carried out the assessment.  
4. A notifying authority shall not offer or provide any activities that conformity 
assessment bodies or consultancy services perform on a commercial or competitive 
basis.  
5. A notifying authority shall safeguard the confidentiality of the information it obtains.  
6. A notifying authority shall hav e a sufficient number of competent personnel at its 
disposal for the proper performance of its tasks.  EN 31   EN Article 22  
Information obligation on notifying authorities  
Member States shall inform the Commission of their procedures for the assessment and 
notificati on of conformity assessment bodies and the monitoring of notified bodies, and of 
any changes thereto.  
The Commission shall make that information publicly available.  
Article 23  
Requirements relating to notified bodies  
1. For the purposes of notification, a conformity assessment body shall meet the 
requirements laid down in paragraphs 2 to 11.  
2. A conformity assessment body shall be established under the national law of a 
Member State and have legal personality.  
3. A conformity assessment body shall be a thi rd-party body independent of the 
organisation or the CE  marked fertilising products it assesses.  
A body belonging to a business association or professional federation representing 
undertakings involved in the design, manufacturing, provision, or use of CE  marked 
fertilising products which it assesses, may, on condition that its independence and the 
absence of any conflict of interest are demonstrated, be considered such a body.  
4. A conformity assessment body, its top level management and the personnel 
responsible for carrying out the conformity assessment tasks shall not be the 
designer, manufacturer, supplier, purchaser, owner, or user of fertilising products nor 
the representative of any of those parties. This shall not preclude the use of fertilising 
products that are necessary for the operations of the conformity assessment body or 
the use of fertilising products for personal purposes.  
A conformity assessment body, its top level management and the personnel 
responsible for carrying out the conformity a ssessment tasks shall not be directly 
involved in the design, manufacture, marketing, or use of fertilising products or 
represent the parties engaged in those activities. They shall not engage in any activity 
that may conflict with their independence of ju dgement or integrity in relation to 
conformity assessment activities for which they are notified. This shall in particular 
apply to consultancy services.  
Conformity assessment bodies shall ensure that the activities of their subsidiaries or 
subcontractors  do not affect the confidentiality, objectivity or impartiality of their 
conformity assessment activities.  
5. Conformity assessment bodies and their personnel shall carry out the conformity 
assessment activities with the highest degree of professional int egrity and the 
requisite technical competence in the specific field and shall be free from all 
pressures and inducements, particularly financial, which might influence their 
judgement or the results of their conformity assessment activities, especially as 
regards persons or groups of persons with an interest in the results of those activities.  
6. A conformity assessment body shall be capable of carrying out all the conformity 
assessment tasks assigned to it by Annex IV and in relation to which it has been 
notified, whether those tasks are carried out by the conformity assessment body itself 
or on its behalf and under its responsibility.  EN 32   EN At all times and for each conformity assessment procedure and each kind or category 
of CE  marked fertilising products in re lation to which it has been notified, a 
conformity assessment body shall have at its disposal the necessary:  
(a) personnel with technical knowledge and sufficient and appropriate experience 
to perform the conformity assessment tasks;  
(b) descriptions of procedures  in accordance with which conformity assessment is 
carried out, ensuring the transparency and the ability of reproduction of those 
procedures. It shall have appropriate policies and procedures in place that 
distinguish between tasks it carries out as a not ified body and other activities;  
(c) procedures for the performance of activities which take due account of the size 
of an undertaking, the sector in which it operates, its structure, the degree of 
complexity of the product technology in question and the mass or serial nature 
of the production process.  
A conformity assessment body shall have the means necessary to perform the 
technical and administrative tasks connected with the conformity assessment 
activities in an appropriate manner and shall have access to all necessary equipment 
or facilities.  
7. The personnel responsible for carrying out the conformity assessment tasks shall 
have the following:  
(a) sound technical and vocational training covering all the conformity assessment 
activities in relation to which th e conformity assessment body has been 
notified;  
(b) satisfactory knowledge of the requirements of the assessments they carry out 
and adequate authority to carry out those assessments;  
(c) appropriate knowledge and understanding of the requirements set out in 
Anne x I, Annex II and Annex  III, of the applicable harmonised standards and 
of the relevant provisions of Union harmonisation legislation and of national 
legislation;  
(d) the ability to draw up certificates, records and reports demonstrating that 
assessments have  been carried out.  
8. The impartiality of the conformity assessment bodies, their top level management 
and of the personnel responsible for carrying out the conformity assessment tasks 
shall be guaranteed.  
The remuneration of the top level management and personnel responsible for 
carrying out the conformity assessment tasks of a conformity assessment body shall 
not depend on the number of assessments carried out or on the results of those 
assessments.  
9. Conformity assessment bodies shall take out liabilit y insurance unless liability is 
assumed by the State in accordance with national law, or the Member State itself is 
directly responsible for the conformity assessment.  
10. The personnel of a conformity assessment body shall observe professional secrecy 
with regard to all information obtained in carrying out their tasks under Annex IV, 
except in relation to the competent authorities of the Member State in which its 
activities are carried out. Proprietary rights shall be protected.  EN 33   EN 11. Conformity assessment b odies shall participate in, or ensure that their personnel 
responsible for carrying out the conformity assessment tasks are informed of, the 
relevant standardisation activities and the activities of the notified body coordination 
group established under Ar ticle 35 and shall apply as general guidance the 
administrative decisions and documents produced as a result of the work of that 
group.  
Article 24  
Presumption of conformity of notified bodies  
Where a conformity assessment body demonstrates its conformity with the criteria laid down 
in the relevant harmonised standards or parts thereof the references of which have been 
published in the Official Journal of the European Union  it shall be presumed to comply with 
the requirements set out in Article 23 in so far as the applicable harmonised standards cover 
those requirements.  
Article 25  
Subsidiaries of and subcontracting by notified bodies  
1. Where a notified body subcontracts specific tasks connected  with conformity 
assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or 
the subsidiary meets the requirements set out in Article 23 and shall inform the 
notifying authority accordingly.  
2. Notified bodies shall take full resp onsibility for the tasks performed by 
subcontractors or subsidiaries wherever these are established.  
3. Activities may be subcontracted or carried out by a subsidiary only with the 
agreement of the client.  
4. Notified bodies shall keep at the disposal of t he notifying authority the relevant 
documents concerning the assessment of the qualifications of the subcontractor or the 
subsidiary and the work carried out by them under Annex IV.  
Article 26  
Application for notification  
1. A conformity assessment body sh all submit an application for notification to the 
notifying authority of the Member State in which it is established.  
2. The application for notification shall be accompanied by a description of the 
conformity assessment activities, the conformity assessme nt module or modules and 
the CE  marked fertilising product or products for which that body claims to be 
competent, as well as by an accreditation certificate issued by a national accreditation 
body attesting that the conformity assessment body fulfils the requirements laid 
down in Article 23.  
Article 27  
Notification procedure  
1. Notifying authorities may notify only conformity assessment bodies which have 
satisfied the requirements laid down in Article 23.  EN 34   EN 2. They shall notify the Commission and the other M ember States using the electronic 
notification tool developed and managed by the Commission.  
3. The notification shall include full details of the conformity assessment activities, the 
conformity assessment module or modules and CE  marked fertilising produ ct or 
products concerned and the accreditation certificate referred to in Article  26(2).  
4. The body concerned may perform the activities of a notified body only where no 
objections are raised by the Commission or the other Member States within two 
weeks o f a notification.  
Only such a body shall be considered a notified body for the purposes of this 
Regulation.  
5. The notifying authority shall notify the Commission and the other Member States of 
any subsequent relevant changes to the notification.  
Article 2 8 
Identification numbers and lists of notified bodies  
1. The Commission shall assign an identification number to a notified body.  
It shall assign a single such number even where the body is notified under several 
Union acts.  
2. The Commission shall make pu blicly available the list of the bodies notified under 
this Regulation, including the identification numbers that have been assigned to them 
and the activities for which they have been notified.  
The Commission shall ensure that the list is kept up to date.  
Article 29  
Changes to notifications  
1. Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements laid down in Article 23 or that it is failing to fulfil 
its obligations, the notifying authority shall restrict, suspend or withdraw notification 
as appropriate, depending on the seriousness of the failure to meet those 
requirements or fulfil those obligations. It shall immediately inform the Commission 
and the other Member States accordingly.  
2. In the event of restriction, suspension or withdrawal of notification, or where the 
notified body has ceased its activity, the notifying Member State shall take 
appropriate steps to ensure that the files of that body are either processed by another 
notified b ody or kept available for the responsible notifying and market surveillance 
authorities at their request.  
Article 30  
Challenge of the competence of notified bodies  
1. The Commission shall investigate all cases where it doubts, or doubt is brought to its 
attention regarding, the competence of a notified body or the continued fulfilment by 
a notified body of the requirements and responsibilities to which it is subject.  EN 35   EN 2. The notifying Member State shall provide the Commission, on request, with all 
informatio n relating to the basis for the notification or the maintenance of the 
competence of the notified body concerned.  
3. The Commission shall ensure that all sensitive information obtained in the course of 
its investigations is treated confidentially.  
4. Where  the Commission ascertains that a notified body does not meet or no longer 
meets the requirements for its notification, it shall adopt an implementing act 
requiring the notifying Member State to take the necessary corrective measures, 
including withdrawal of notification if necessary.  
That implementing act shall be adopted in accordance with the advisory procedure 
referred to in Article  41(2).  
Article 31  
Operational obligations of notified bodies  
1. Notified bodies shall carry out conformity assessments in accordance with the 
conformity assessment procedures provided for in Annex IV.  
2. Conformity assessments shall be carried out in a proportionate manner, avoiding 
unnecessary burdens for economic operators. Notified bodies shall perform their 
activities tak ing due account of the size of an undertaking, the sector in which it 
operates, its structure, the degree of complexity of the product technology in question 
and the mass or serial nature of the production process.  
In so doing they shall nevertheless respe ct the degree of rigour and the level of 
protection required for the compliance of the CE  marked fertilising product with this 
Regulation.  
3. Where a notified body finds that the requirements set out in Annex I, Annex II or 
Annex  III, or corresponding harm onised standards, common specifications referred 
to in Article  13 or other technical specifications, have not been met by a 
manufacturer, it shall require that manufacturer to take appropriate corrective 
measures and shall not issue a certificate.  
4. Where , in the course of the monitoring of conformity following the issue of a 
certificate, a notified body finds that a CE  marked fertilising product no longer 
complies, it shall require the manufacturer to take appropriate corrective measures 
and shall suspend  or withdraw the certificate if necessary.  
5. Where corrective measures are not taken or do not have the required effect, the 
notified body shall restrict, suspend or withdraw any certificates, as appropriate.  
Article 32  
Appeal against decisions of notifie d bodies  
Member States shall ensure that an appeal procedure against decisions of the notified 
bodies is available.  
Article 33  
Information obligation on notified bodies  
1. Notified bodies shall inform the notifying authority of the following:  EN 36   EN (a) any refusal, restriction, suspension or withdrawal of a certificate;  
(b) any circumstances affecting the scope of or conditions for notification;  
(c) any request for information which they have received from market surveillance 
authorities regarding conformity assessment activ ities;  
(d) on request, conformity assessment activities performed within the scope of 
their notification and any other activity performed, including cross -border 
activities and subcontracting.  
2. Notified bodies shall provide the other bodies notified under th is Regulation carrying 
out similar conformity assessment activities covering the same CE  marked fertilising 
products with relevant information on issues relating to negative and, on request, 
positive conformity assessment results.  
Article 34  
Exchange of ex perience  
The Commission shall provide for the organisation of exchange of experience between the 
Member States' national authorities responsible for notification policy.  
Article 35  
Coordination of notified bodies  
The Commission shall ensure that appropriat e coordination and cooperation between bodies 
notified under this Regulation are put in place and properly operated in the form of a sectoral 
group of notified bodies.  
Member States shall ensure that the bodies notified by them participate in the work of t hat 
group, directly or by means of designated representatives.  
CHAPTER 5  
UNION MARKET SURVEIL LANCE, CONTROL OF 
CE MARKED FERTILISING P RODUCTS ENTERING THE  
UNION MARKET AND UNI ON SAFEGUARD PROCEDU RE 
Article 36  
Union market surveillance and control of CE marked fertilising products entering the 
Union market  
Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to CE  marked 
fertilising products.  
Article 37  
Procedure for dealing with CE  marked fertilising products presenting a risk at national 
level 
1. Where the market surveillance authorities of one Member State have sufficient 
reason to believe that a CE  marked fertilising product presents an unacceptable risk 
to human, animal or plant health, to safety or to the environment, they shall carry out 
an evaluation in relation to the fertilising product concerned covering the 
requirements laid down in this Regulation. The relevant economic operators shall 
cooperate as necessary with the market surveillance authorities for that purpose.  EN 37   EN Where, in the co urse of the evaluation, the market surveillance authorities find that 
the CE market fertilising product does not comply with the requirements laid down 
in this Regulation, they shall without delay require the economic operator to take all 
appropriate corre ctive actions within a reasonable period to bring the fertilising 
product into compliance with those requirements, to withdraw the fertilising product 
from the market, to recall it, or to remove the CE marking.  
The market surveillance authorities shall inf orm the relevant notified body 
accordingly.  
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in 
the second subparagraph.  
2. Where the market surveillance authorities consider that non -compliance is not 
restricted to their n ational territory, they shall inform the Commission and the other 
Member States of the results of the evaluation and of the actions which they have 
required the economic operator to take.  
3. The economic operator shall ensure that all appropriate correctiv e action is taken in 
respect of all the CE  marked fertilising products concerned that it has made available 
on the market throughout the Union.  
4. Where the relevant economic operator does not take adequate corrective action 
within the period referred to in the second subparagraph of paragraph 1, the market 
surveillance authorities shall take all appropriate provisional measures to prohibit or 
restrict the CE  marked fertilising product being made available on their national 
market, to withdraw the fertilis ing product from that market or to recall it.  
The market surveillance authorities shall inform the Commission and the other 
Member States, without delay, of those measures.  
5. The information referred to in the second subparagraph of paragraph 4 shall include 
all available details, in particular the data necessary for the identification of the non -
compliant CE  marked fertilising product, the origin of that fertilising product, the 
nature of the non -compliance alleged and the risk involved, the nature an d duration 
of the national measures taken and the arguments put forward by the relevant 
economic operator. In particular, the market surveillance authorities shall indicate 
whether the non -compliance is due to either of the following:  
(a) failure of the CE  marked fertilising product to meet the requirements set out in 
Annexes  I, II or III  
(b) shortcomings in the harmonised standards referred to in Article 12 conferring a 
presumption of conformity.  
6. Member States other than the Member State initiating the procedu re under this 
Article shall without delay inform the Commission and the other Member States of 
any measures adopted and of any additional information at their disposal relating to 
the non -compliance of the CE  marked fertilising product concerned, and, in t he event 
of disagreement with the adopted national measure, of their objections.  
7. Where, within three months of receipt of the information referred to in the second 
subparagraph of paragraph 4, no objection has been raised by either a Member State 
or the  Commission in respect of a provisional measure taken by a Member State, that 
measure shall be deemed justified.  EN 38   EN 8. Member States shall ensure that appropriate restrictive measures, such as withdrawal, 
are taken without delay in respect of the CE  marked fe rtilising product concerned.  
Article 38  
Union safeguard procedure  
1. Where, on completion of the procedure set out in Article 37(3) and (4), objections 
are raised against a measure taken by a Member State, or where the Commission 
considers a national measu re to be contrary to Union legislation, the Commission 
shall without delay enter into consultation with the Member States and the relevant 
economic operator or operators and shall evaluate the national measure. On the basis 
of the results of that evaluatio n, the Commission shall adopt an implementing act in 
the form of a decision determining whether the national measure is justified or not.  
If the national measure is considered justified, the decision shall order all Member 
States to take the necessary meas ures to ensure that the non -compliant CE  marked 
fertilising product is withdrawn from their market, and to inform the Commission 
accordingly.  
If the national measure is considered unjustified, the decision shall order the Member 
State concerned to withdra w that measure.  
The Commission shall address its decision to all Member States and shall 
immediately communicate it to them and the relevant economic operator or 
operators.  
2. Where the national measure is considered justified and the non -compliance of the  
CE marked fertilising product is attributed to shortcomings in the harmonised 
standards referred to in point (b) of Article 37(5), the Commission shall apply the 
procedure provided for in Article 11 of Regulation (EU) No 1025/2012.  
Article 39  
Compliant CE  marked fertilising products which present a risk  
1. Where, having carried out an evaluation under Article 37(1), a Member State finds 
that although a CE  marked fertilising product is in compliance with this Regulation it 
presents an unacceptable risk to h uman, animal or plant health, to safety or to the 
environment, it shall require the relevant economic operator to take all appropriate 
measures within a reasonable period to ensure that the fertilising product concerned, 
when placed on the market, no longe r presents that risk, to withdraw the fertilising 
product from the market or to recall it.  
2. The economic operator shall ensure that corrective action is taken in respect of all the 
CE marked fertilising products concerned that he or she has made availabl e on the 
market throughout the Union.  
3. The Member State shall immediately inform the Commission and the other Member 
States. That information shall include all available details, in particular the data 
necessary for the identification of the CE  marked fe rtilising product concerned, the 
origin and the supply chain of that fertilising product, the nature of the risk involved 
and the nature and duration of the national measures taken.  
4. The Commission shall without delay enter into consultation with the Member States 
and the relevant economic operator or operators and shall evaluate the national 
measures taken. On the basis of the results of that evaluation, the Commission shall EN 39   EN adopt an implementing act in the form of a decision determining whether the n ational 
measure is justified or not, and where necessary, ordering appropriate measures.  
Those implementing acts shall be adopted in accordance with the examination 
procedure referred to in Article  41(3).  
On duly justified imperative grounds of urgency rel ating to the protection of human, 
animal or plant health, safety or the environment, the Commission shall adopt 
immediately applicable implementing acts in accordance with the procedure referred 
to in Article 41(4).  
5. The Commission shall address its deci sion to all Member States and shall 
immediately communicate it to them and the relevant economic operator or 
operators.  
Article 40  
Formal non -compliance  
1. Without prejudice to Article 37, where a Member State makes one of the following 
findings on a CE  marked fertilising product, it shall require the relevant economic 
operator to put an end to the non -compliance concerned:  
(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) 
No 765/2008 or of Article 17 of this Regulation;  
(b) the iden tification number of the notified body has been affixed in violation of 
Article 17 or has not been affixed, where required by Article 17;  
(c) the EU declaration of conformity does not accompany the CE  marked 
fertilising product;  
(d) the EU declaration of conformit y has not been drawn up correctly;  
(e) technical documentation is either not available or not complete;  
(f) the information referred to in Article 6(6) or Article 8(3) is absent, false or 
incomplete;  
(g) any other administrative requirement provided for in Article 6 o r Article 8 is 
not fulfilled.  
2. Where the non -compliance referred to in paragraph 1 persists, the Member State 
concerned shall take all appropriate measures to restrict or prohibit the CE  marked 
fertilising product being made available on the market or en sure that it is recalled or 
withdrawn from the market or that the CE  marking is removed.  
CHAPTER 6  
COMMITTEE AND DELEGA TED ACTS  
Article 41  
Committee procedure  
1. The Commission shall be assisted by the Committee on Fertilising products. That 
committee shall be a committee within the meaning of Regulation (EU) 
No 182/2011.  
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) 
No 182/2011 shall apply.  EN 40   EN 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) 
No 182/2011 shall apply.  
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) 
No 182/2011, in conjunction with Article 5 thereof, shall apply.  
Article 4 2 
Amendments of Annexes  
1. The Commission shall be empowered to adopt delegated acts in accordance with 
Article 43 to amend Annexes  I to IV for the purposes of adapting them to technical 
progress and facilitating internal market access and free movement fo r CE  marked 
fertilising products  
(a) which are likely to be subject of significant trade on the internal market, and  
(b) for which there is scientific evidence that the they do not present an 
unacceptable risk to human, animal or plant health, to safety or to the  
environment, and that they are sufficiently effective.  
2. Where the Commission amends Annex  II in order to add new micro -organisms to the 
component material category for such organisms pursuant to paragraph  1, it shall do 
so on the basis of the following data:  
(a) name of the micro -organism;  
(b) taxonomic classification of the micro -organism;  
(c) historical data of safe production and use of the micro -organism  
(d) taxonomic relation to micro -organism species fulfilling the requirements for a 
Qualified Presumption of Safety as established by the European Food Safety 
Agency;  
(e) information on residue levels of toxins;  
(f) information on the production process; and  
(g) information on the identity of residual intermediates or microbial metabolites 
in the component material.  
3. When adopting delegated acts in accordance with paragraph  1, the Commission may 
amend the component material categories set out in Annex II in order to add animal 
by-products within the meaning of Regulation  (EC) No 1069/2009 only where an 
end point in the manu facturing chain has been determined for such products in 
accordance with the procedures laid down in that Regulation.  
4. The Commission shall also be empowered to adopt delegated acts in accordance with 
Article 43 to amend Annexes  I to IV in the light of n ew scientific evidence. The 
Commission shall use this empowerment where, based on a risk assessment, an 
amendment proves necessary to ensure that any CE  marked fertilising product 
complying with the requirements of this Regulation does not, under normal 
conditions of use, present an unacceptable risk to human, animal, or plant health, to 
safety or to the environment.  EN 41   EN Article 43  
Exercise of the delegation  
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article.  
2. The power to adopt delegated acts referred to in Article 42 shall be conferred on the 
Commission for five years from [Publications office, please insert the date of entry 
into force of this Regulation]. The Commission shall draw up a re port in respect of 
the delegation of power not later than nine months before the end of the five -year 
period. The delegation of power shall be tacitly extended for periods of an identical 
duration, unless the European Parliament or the Council opposes such  extension not 
later than three months before the end of each period.  
3. The delegation of power referred to in Article 42 may be revoked at any time by the 
European Parliament or by the Council. A decision to revoke shall put an end to the 
delegation of t he power specified in that decision. It shall take effect the day 
following the publication of the decision in the Official Journal of the European 
Union  or at a later date specified therein. It shall not affect the validity of any 
delegated acts already i n force.  
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  
5. A delegated act adopted pursuant to Article 42 shall enter into force only if no 
objection has been expresse d either by the European Parliament or the Council 
within a period of two months of notification of that act to the European Parliament 
and the Council or if, before the expiry of that period, the European Parliament and 
the Council have both informed the Commission that they will not object. That 
period shall be extended by two months at the initiative of the European Parliament 
or of the Council.  
CHAPTER 7  
TRANSITIONAL AND FIN AL PROVISIONS  
Article 44  
Penalties  
Member States shall lay down rules on penalti es applicable to infringements of this 
Regulation and shall take all measures necessary to ensure that they are 
implemented. The penalties provided for shall be effective, proportionate and 
dissuasive. Member States shall, without delay, notify the Commiss ion of those rules 
and of those measures and shall notify it, without delay, of any subsequent 
amendment affecting them.  
Article 45  
Amendments to Regulation (EC) No 1069/2009  
In Regulation (EC) No 1069/2009, Article  5 is amended as follows:  
(1) in paragraph  2, the first subparagraph is replaced by the following:  
"For derived products referred to in Articles 32, 35 and 36 which no longer 
pose any significant risk to public or animal health, an end point in the EN 42   EN manufacturing chain may be determine d, beyond which they are no longer 
subject to the requirements of this Regulation.";  
(2) paragraph  3 is replaced by the following:  
"3. In the event of risks to public or animal health, Articles  53 and 54 of 
Regulation  (EC) No  178/2002 concerning emergency hea lth measures 
shall apply mutatis mutandis to the derived products referred to in 
Articles 32, 33 and 36 of this Regulation."  
Article 46  
Amendments to Regulation (EC) No 1107/2009  
Regulation (EC) No 1107/2009 is amended as follows:  
(1) Article  2(1) (b) is replaced by the following:  
"(b) influencing the life processes of plants, such as substances influencing 
their growth, other than as a nutrient or a plant biostimulant;"  
(2) in Article  3, the following point is added:  
(3) "34. "plant biostimulant" means a product stimulating plant nutrition 
processes independently of the product's nutrient content with the sole aim of 
improving one or more of the following characteristics of the plant:  
(a) nutrient use efficiency;  
(b) tolerance to abiotic stress;  
(c) crop quality traits."  
Article 47  
Repeal of Regulation  (EC) No  2003/2003  
Regulation  (EC) No  2003/2003 is repealed with effect from the date referred to in the second 
paragraph of Article  49. 
References to the repealed Regulation shall be construed as references to this Regulation.  
Article 48  
Transitional provisions  
Member States shall not impede the making available on the market of products which were 
placed on the market as fertilisers designated "EC fertiliser" in conformity with 
Regulation  (EC) No  2003/2003 before [Publications o ffice, please insert the date of 
application of this Regulation]. However, Chapter  5 shall apply mutatis mutandis  to such 
products.  
Article 49  
Entry into force and application  
This Regulation shall enter into force on the twentieth day following that of it s publication in 
the Official Journal of the European Union . 
It shall apply from 1  January  2018.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  EN 43   EN Done at Brussels,  
For the European Parliament  For the Council  
The President  The President