- Status
- In Force
- Penalty ceiling
- Regulated
Does it bind you?
Business-side roles with duties under this instrument.
Manufacturer28
Any Person8
Conformity Assessment Body4
Operator3
Distributor1
Plus 9 duties on the regulator, Crown ministers and public bodies — folded into the section list below.
Other Acts binding the same actors
If a role above is yours, these are the other instruments that most often bind it.
Manufacturer — also bound by 502 other Acts
Measuring Instruments Regulations 2016
85 duties
Human Medicines Regulations 2012
75 duties
Any Person — also bound by 2340 other Acts
Human Medicines Regulations 2012
184 duties
Merchant Shipping Act 1995
144 duties
Insolvency (England and Wales) Rules 2016
104 duties
Communications Act 2003
92 duties
Road Traffic Act 1988
92 duties
Conformity Assessment Body — also bound by 47 other Acts
Lifts Regulations 2016
28 duties
Radio Equipment Regulations 2017
27 duties
Explosives Regulations 2014
22 duties
Operator — also bound by 746 other Acts
Regulation (EU) No 965/2012 (Air Operations)
203 duties
Space Industry Regulations 2021
76 duties
Distributor — also bound by 182 other Acts
UK REACH Regulation (retained EU law)
44 duties
What it requires
Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.
uri:annex/iii
uri:annex/iii
Regulated
- Ensure your EU fertilising product label complies with all Annex III requirementsAny Person
uri:annex/i/part/ii/division/10/division/2
uri:annex/i/part/ii/division/10/division/2
Regulated
- Do not market organic fertiliser containing biuretAny Person
uri:annex/i/part/ii/division/10/division/3
uri:annex/i/part/ii/division/10/division/3
Regulated
- Ensure copper and zinc levels in organic fertiliser do not exceed limitsAny Person
uri:annex/i/part/ii/division/31/division/3
uri:annex/i/part/ii/division/31/division/3
Regulated
- Limit copper and zinc content in inorganic soil improversAny Person
uri:annex/i/part/ii/division/37/division/3
uri:annex/i/part/ii/division/37/division/3
Regulated
- Ensure copper and zinc limits in plant biostimulantsAny Person
uri:annex/iv/part/i/division/4
uri:annex/iv/part/i/division/4
Regulated
- Do not use Module D1 for high-nitrogen ammonium nitrate fertilisers or blendsManufacturer
uri:annex/iv/part/ii/division/1/division/2/division/2.1
uri:annex/iv/part/ii/division/1/division/2/division/2.1
Regulated
- Establish technical documentation with risk analysis for EU fertilising productsManufacturer
uri:annex/iv/part/ii/division/1/division/3
uri:annex/iv/part/ii/division/1/division/3
Regulated
- Ensure manufacturing process and monitoring comply with regulationsManufacturer
uri:annex/iv/part/ii/division/1/division/4
uri:annex/iv/part/ii/division/1/division/4
Regulated
- Affix CE marking and prepare EU declaration of conformity for fertilising productsManufacturer
uri:annex/iv/part/ii/division/2/division/2/division/2.1
uri:annex/iv/part/ii/division/2/division/2/division/2.1
Regulated
- Prepare and retain technical documentation for your EU fertilising productManufacturer
uri:annex/iv/part/ii/division/2/division/3
uri:annex/iv/part/ii/division/2/division/3
Regulated
- Ensure manufacturing process and monitoring comply with technical documentation and regulationManufacturer
uri:annex/iv/part/ii/division/2/division/5
uri:annex/iv/part/ii/division/2/division/5
Regulated
- Affix CE marking, draw up declaration of conformity and keep recordsManufacturer
uri:annex/iv/part/ii/division/2/division/6/division/6.2
uri:annex/iv/part/ii/division/2/division/6/division/6.2
Regulated
Other duties (1) — Crown / regulator
- Notified body must request manufacturer to take necessary measures under Article 6(8)Statutory regulator
uri:annex/iv/part/ii/division/3/division/2/division/2.1
uri:annex/iv/part/ii/division/3/division/2/division/2.1
Regulated
- Establish technical documentation for EU fertilising productsManufacturer
uri:annex/iv/part/ii/division/3/division/3/division/3.1
uri:annex/iv/part/ii/division/3/division/3/division/3.1
Regulated
- Apply to a notified body for EU-type examination of your fertilising productManufacturer
uri:annex/iv/part/ii/division/3/division/4
uri:annex/iv/part/ii/division/3/division/4
Regulated
Other duties (1) — Crown / regulator
- Notified body must assess technical design and test EU fertilising productsStatutory regulator
uri:annex/iv/part/ii/division/3/division/5
uri:annex/iv/part/ii/division/3/division/5
Regulated
Other duties (1) — Crown / regulator
- Notified body must keep evaluation report confidential without manufacturer's consentStatutory regulator
uri:annex/iv/part/ii/division/3/division/6
uri:annex/iv/part/ii/division/3/division/6
Regulated
Other duties (1) — Crown / regulator
- Notified body must issue or refuse EU-type examination certificateStatutory regulator
uri:annex/iv/part/ii/division/3/division/7
uri:annex/iv/part/ii/division/3/division/7
Regulated
- Inform the notified body of any modifications to your approved fertiliser productManufacturer
uri:annex/iv/part/ii/division/3/division/8
uri:annex/iv/part/ii/division/3/division/8
Regulated
- Notified bodies must report EU-type examination certificate decisions to authorities and peersConformity Assessment Body
uri:annex/iv/part/ii/division/3/division/9
uri:annex/iv/part/ii/division/3/division/9
Regulated
- Keep EU-type examination certificate and technical docs for 5 yearsManufacturer
uri:annex/iv/part/ii/division/4/division/2
uri:annex/iv/part/ii/division/4/division/2
Regulated
- Ensure manufacturing process and monitoring conform to approved type and RegulationManufacturer
uri:annex/iv/part/ii/division/4/division/3
uri:annex/iv/part/ii/division/4/division/3
Regulated
- Affix CE marking and prepare EU declaration of conformity for fertilising productsManufacturer
uri:annex/iv/part/ii/division/5/division/2/division/2.1
uri:annex/iv/part/ii/division/5/division/2/division/2.1
Regulated
- Establish technical documentation for your fertilising productManufacturer
uri:annex/iv/part/ii/division/5/division/3
uri:annex/iv/part/ii/division/5/division/3
Regulated
- Keep technical records for 5 years after placing fertiliser on the marketManufacturer
uri:annex/iv/part/ii/division/5/division/4
uri:annex/iv/part/ii/division/5/division/4
Regulated
- Operate an approved quality system for EU fertilising productsManufacturer
uri:annex/iv/part/ii/division/5/division/5/division/5.1.1.1
uri:annex/iv/part/ii/division/5/division/5/division/5.1.1.1
Regulated
- Set up and maintain a quality management system for EU fertilising productsManufacturer
uri:annex/iv/part/ii/division/5/division/5/division/5.1.3.1
uri:annex/iv/part/ii/division/5/division/5/division/5.1.3.1
Regulated
- Log input material batches, train staff, inspect and test fertiliser outputManufacturer
uri:annex/iv/part/ii/division/5/division/5/division/5.1.5.1
uri:annex/iv/part/ii/division/5/division/5/division/5.1.5.1
Regulated
- Establish and document internal audit procedure for quality managementManufacturer
uri:annex/iv/part/ii/division/5/division/5/division/5.3.1
uri:annex/iv/part/ii/division/5/division/5/division/5.3.1
Regulated
Other duties (1) — Crown / regulator
- Notified body must assess your quality system against requirementsStatutory regulator
uri:annex/iv/part/ii/division/5/division/5/division/5.4
uri:annex/iv/part/ii/division/5/division/5/division/5.4
Regulated
- Maintain your approved quality system and fulfil its obligationsManufacturer
uri:annex/iv/part/ii/division/5/division/5/division/5.5.1
uri:annex/iv/part/ii/division/5/division/5/division/5.5.1
Regulated
- Notify the notified body of any intended changes to your quality systemManufacturer
uri:annex/iv/part/ii/division/5/division/5/division/5.5.2
uri:annex/iv/part/ii/division/5/division/5/division/5.5.2
Regulated
Other duties (1) — Crown / regulator
- Notified body must evaluate proposed quality system changesStatutory regulator
uri:annex/iv/part/ii/division/5/division/6/division/6.3.1
uri:annex/iv/part/ii/division/5/division/6/division/6.3.1
Regulated
Other duties (1) — Crown / regulator
- Notified body must audit your quality system periodicallyStatutory regulator
uri:annex/iv/part/ii/division/5/division/6/division/6.4
uri:annex/iv/part/ii/division/5/division/6/division/6.4
Regulated
- Notified body must provide visit and test reports to manufacturerConformity Assessment Body
uri:annex/iv/part/ii/division/5/division/7
uri:annex/iv/part/ii/division/5/division/7
Regulated
- Affix CE marking and keep EU declaration of conformity for 5 yearsManufacturer
uri:annex/iv/part/ii/division/5/division/8
uri:annex/iv/part/ii/division/5/division/8
Regulated
- Keep fertilising product documentation for 5 years for national authoritiesManufacturer
uri:annex/iv/part/ii/division/5/division/9
uri:annex/iv/part/ii/division/5/division/9
Regulated
Other duties (1) — Crown / regulator
- Notified body must report quality system approvals to its notifying authority and other bodiesStatutory regulator
s.art006
Obligations of manufacturers
Regulated
- Ensure EU fertilising products are designed, tested and labelled correctlyManufacturer
s.art007
Authorised representative
Regulated
- Authorised representative must keep conformity documents and cooperate with authoritiesAny Person
s.art008
Obligations of importers
Regulated
- Ensure EU fertilising products meet regulatory compliance before placing on marketManufacturer
s.art009
Obligations of distributors
Regulated
- Check and handle EU fertilising products with due careDistributor
s.art010
Cases in which obligations of manufacturers apply to importers and distributors
Regulated
- Comply with manufacturer obligations when selling fertiliser under your own brand or making modificationsManufacturer
s.art011
Packaging and repackaging by importers and distributors
Regulated
- Label and keep records when packaging or repackaging fertilising productsManufacturer
s.art012
Identification of economic operators
Regulated
- Keep records of fertiliser product supply chain for 5 years and identify suppliers and customers to authorities on requestOperator
s.art016
EU declaration of conformity
Regulated
- Draw up and maintain EU declaration of conformity for fertilising productsManufacturer
s.art024
Requirements relating to notified bodies
Regulated
- Meet all requirements to act as a notified body for EU fertilising productsConformity Assessment Body
s.art026
Subsidiaries of and subcontracting by notified bodies
Regulated
- Notified bodies must manage subcontractors and subsidiaries and get client agreementConformity Assessment Body
s.art032
Operational obligations of notified bodies
Regulated
Other duties (1) — Crown / regulator
- Notified bodies must assess EU fertilising products fairly and enforce complianceStatutory regulator
s.art034
Information obligation on notified bodies
Regulated
- Notified bodies must report certification decisions and share information with regulators and other bodiesAny Person
s.art036
Coordination of notified bodies
Regulated
- Notified bodies must participate in EU fertiliser product coordination groupAny Person
s.art038
Procedure at national level for dealing with EU fertilising products presenting a risk
Regulated
- Cooperate with market surveillance authorities investigating risky fertilising productsOperator
s.art040
Compliant EU fertilising products which present a risk
Regulated
- Take corrective action when a compliant fertilising product presents a riskOperator
63 other provisions — procedural and definitional
uri:annex/i/part/ii/division/10/division/4
uri:annex/i/part/ii/division/10/division/4
uri:annex/i/part/ii/division/21/division/3
uri:annex/i/part/ii/division/21/division/3
uri:annex/i/part/ii/division/3
uri:annex/i/part/ii/division/3
uri:annex/i/part/ii/division/31/division/2
uri:annex/i/part/ii/division/31/division/2
uri:annex/i/part/ii/division/35
uri:annex/i/part/ii/division/35
uri:annex/i/part/ii/division/36
uri:annex/i/part/ii/division/36
uri:annex/i/part/ii/division/37/division/4
uri:annex/i/part/ii/division/37/division/4
uri:annex/i/part/ii/division/40/division/3
uri:annex/i/part/ii/division/40/division/3
uri:annex/i/part/ii/division/40/division/4
uri:annex/i/part/ii/division/40/division/4
uri:annex/iv/part/ii/division/1/division/2/division/2.2
uri:annex/iv/part/ii/division/1/division/2/division/2.2
uri:annex/iv/part/ii/division/2/division/2/division/2.2
uri:annex/iv/part/ii/division/2/division/2/division/2.2
uri:annex/iv/part/ii/division/2/division/6/division/6.1
uri:annex/iv/part/ii/division/2/division/6/division/6.1
uri:annex/iv/part/ii/division/3/division/2/division/2.2
uri:annex/iv/part/ii/division/3/division/2/division/2.2
uri:annex/iv/part/ii/division/3/division/3/division/3.2
uri:annex/iv/part/ii/division/3/division/3/division/3.2
uri:annex/iv/part/ii/division/4/division/1
uri:annex/iv/part/ii/division/4/division/1
uri:annex/iv/part/ii/division/5/division/2/division/2.2
uri:annex/iv/part/ii/division/5/division/2/division/2.2
uri:annex/iv/part/ii/division/5/division/5/division/5.1.4.1
uri:annex/iv/part/ii/division/5/division/5/division/5.1.4.1
uri:annex/iv/part/ii/division/5/division/5/division/5.2
uri:annex/iv/part/ii/division/5/division/5/division/5.2
uri:annex/iv/part/ii/division/5/division/5/division/5.3.4
uri:annex/iv/part/ii/division/5/division/5/division/5.3.4
uri:annex/iv/part/ii/division/5/division/6/division/6.2
uri:annex/iv/part/ii/division/5/division/6/division/6.2
uri:annex/iv/part/ii/division/5/division/6/division/6.3.2
uri:annex/iv/part/ii/division/5/division/6/division/6.3.2
uri:annex/v/division/8
uri:annex/v/division/8
s.annex iii para.1
This Annex sets out the labelling requirements for EU fertilising products....
s.annex ii para.1
An EU fertilising product shall consist solely of component materials complying...
s.annex ii para.2
The component materials, and the input materials used to produce...
s.art001
Scope
s.art002
Definitions
s.art003
Free movement
s.art004
Product requirements
s.art005
Making available on the market
s.art013
Presumption of conformity
s.art014
Common specifications
s.art015
Conformity assessment procedures
s.art017
General principles of CE marking
s.art018
Rules and conditions for affixing the CE marking
s.art019
End-of-waste status
s.art020
Notification
s.art021
Notifying authorities
s.art022
Requirements relating to notifying authorities
s.art023
Information obligation on notifying authorities
s.art025
Presumption of conformity of notified bodies
s.art027
Application for notification
s.art028
Notification procedure
s.art029
Identification numbers and lists of notified bodies
s.art030
Changes to notifications
s.art031
Challenge of the competence of notified bodies
s.art033
Appeal against decisions of notified bodies
s.art035
Exchange of experience
s.art037
Union market surveillance and control of EU fertilising products entering the Union market
s.art039
Union safeguard procedure
s.art041
Formal non-compliance
s.art042
Amendments of Annexes
s.art043
Separate delegated acts for separate component material categories
s.art044
Exercise of the delegation
s.art045
Committee procedure
s.art046
Amendments to Regulation (EC) No 1069/2009
s.art047
Amendments to Regulation (EC) No 1107/2009
s.art048
Penalties
s.art049
Report
s.art050
Biodegradability review
s.art051
Repeal of Regulation (EC) No 2003/2003
s.art052
Transitional provisions
s.art053
Entry into force and application
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.