uri:annex/iii
- Ensure your EU fertilising product label complies with all Annex III requirements
Retained EU Law
2019
United Kingdom
Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (Text with EEA relevance)
At a glance
What's here
53 compliance obligations
Who this Act binds
Plus 9 non-business duties on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
uri:annex/i/part/ii/division/10/division/2
- Do not market organic fertiliser containing biuret
uri:annex/i/part/ii/division/10/division/3
- Ensure copper and zinc levels in organic fertiliser do not exceed limits
uri:annex/i/part/ii/division/31/division/3
- Limit copper and zinc content in inorganic soil improvers
uri:annex/i/part/ii/division/37/division/3
- Ensure copper and zinc limits in plant biostimulants
uri:annex/iv/part/i/division/4
- Do not use Module D1 for high-nitrogen ammonium nitrate fertilisers or blends
uri:annex/iv/part/ii/division/1/division/2/division/2.1
- Establish technical documentation with risk analysis for EU fertilising products
uri:annex/iv/part/ii/division/1/division/3
- Ensure manufacturing process and monitoring comply with regulations
uri:annex/iv/part/ii/division/1/division/4
- Affix CE marking and prepare EU declaration of conformity for fertilising products
uri:annex/iv/part/ii/division/2/division/2/division/2.1
- Prepare and retain technical documentation for your EU fertilising product
uri:annex/iv/part/ii/division/2/division/3
- Ensure manufacturing process and monitoring comply with technical documentation and regulation
uri:annex/iv/part/ii/division/2/division/5
- Affix CE marking, draw up declaration of conformity and keep records
uri:annex/iv/part/ii/division/2/division/6/division/6.2
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
- Establish technical documentation for EU fertilising products
uri:annex/iv/part/ii/division/3/division/3/division/3.1
- Apply to a notified body for EU-type examination of your fertilising product
uri:annex/iv/part/ii/division/3/division/4
Other duties (1) — Crown / regulator
- Notified body must assess technical design and test EU fertilising products Statutory regulator
uri:annex/iv/part/ii/division/3/division/5
Other duties (1) — Crown / regulator
- Notified body must keep evaluation report confidential without manufacturer's consent Statutory regulator
uri:annex/iv/part/ii/division/3/division/6
Other duties (1) — Crown / regulator
- Notified body must issue or refuse EU-type examination certificate Statutory regulator
uri:annex/iv/part/ii/division/3/division/7
- Inform the notified body of any modifications to your approved fertiliser product
uri:annex/iv/part/ii/division/3/division/8
- Notified bodies must report EU-type examination certificate decisions to authorities and peers
uri:annex/iv/part/ii/division/3/division/9
- Keep EU-type examination certificate and technical docs for 5 years
uri:annex/iv/part/ii/division/4/division/2
- Ensure manufacturing process and monitoring conform to approved type and Regulation
uri:annex/iv/part/ii/division/4/division/3
- Affix CE marking and prepare EU declaration of conformity for fertilising products
uri:annex/iv/part/ii/division/5/division/2/division/2.1
- Establish technical documentation for your fertilising product
uri:annex/iv/part/ii/division/5/division/3
- Keep technical records for 5 years after placing fertiliser on the market
uri:annex/iv/part/ii/division/5/division/4
- Operate an approved quality system for EU fertilising products
uri:annex/iv/part/ii/division/5/division/5/division/5.1.1.1
- Set up and maintain a quality management system for EU fertilising products
uri:annex/iv/part/ii/division/5/division/5/division/5.1.3.1
- Log input material batches, train staff, inspect and test fertiliser output
uri:annex/iv/part/ii/division/5/division/5/division/5.1.5.1
- Establish and document internal audit procedure for quality management
uri:annex/iv/part/ii/division/5/division/5/division/5.3.1
Other duties (1) — Crown / regulator
- Notified body must assess your quality system against requirements Statutory regulator
uri:annex/iv/part/ii/division/5/division/5/division/5.4
- Maintain your approved quality system and fulfil its obligations
uri:annex/iv/part/ii/division/5/division/5/division/5.5.1
- Notify the notified body of any intended changes to your quality system
uri:annex/iv/part/ii/division/5/division/5/division/5.5.2
Other duties (1) — Crown / regulator
- Notified body must evaluate proposed quality system changes Statutory regulator
uri:annex/iv/part/ii/division/5/division/6/division/6.3.1
Other duties (1) — Crown / regulator
- Notified body must audit your quality system periodically Statutory regulator
uri:annex/iv/part/ii/division/5/division/6/division/6.4
- Notified body must provide visit and test reports to manufacturer
uri:annex/iv/part/ii/division/5/division/7
- Affix CE marking and keep EU declaration of conformity for 5 years
uri:annex/iv/part/ii/division/5/division/8
- Keep fertilising product documentation for 5 years for national authorities
uri:annex/iv/part/ii/division/5/division/9
Other duties (1) — Crown / regulator
- Notified body must report quality system approvals to its notifying authority and other bodies Statutory regulator
Obligations of manufacturers
- Ensure EU fertilising products are designed, tested and labelled correctly
Authorised representative
- Authorised representative must keep conformity documents and cooperate with authorities
Obligations of importers
- Ensure EU fertilising products meet regulatory compliance before placing on market
Obligations of distributors
- Check and handle EU fertilising products with due care
Cases in which obligations of manufacturers apply to importers and distributors
- Comply with manufacturer obligations when selling fertiliser under your own brand or making modifications
Packaging and repackaging by importers and distributors
- Label and keep records when packaging or repackaging fertilising products
Identification of economic operators
- Keep records of fertiliser product supply chain for 5 years and identify suppliers and customers to authorities on request
EU declaration of conformity
- Draw up and maintain EU declaration of conformity for fertilising products
Requirements relating to notified bodies
- Meet all requirements to act as a notified body for EU fertilising products
Subsidiaries of and subcontracting by notified bodies
- Notified bodies must manage subcontractors and subsidiaries and get client agreement
Operational obligations of notified bodies
Other duties (1) — Crown / regulator
- Notified bodies must assess EU fertilising products fairly and enforce compliance Statutory regulator
Information obligation on notified bodies
- Notified bodies must report certification decisions and share information with regulators and other bodies
Coordination of notified bodies
- Notified bodies must participate in EU fertiliser product coordination group
Procedure at national level for dealing with EU fertilising products presenting a risk
- Cooperate with market surveillance authorities investigating risky fertilising products
Compliant EU fertilising products which present a risk
- Take corrective action when a compliant fertilising product presents a risk
Browse 63 other sections — procedural / definitional / commencement
uri:annex/i/part/ii/division/10/division/4
uri:annex/i/part/ii/division/21/division/3
uri:annex/i/part/ii/division/3
uri:annex/i/part/ii/division/31/division/2
uri:annex/i/part/ii/division/35
uri:annex/i/part/ii/division/36
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/4
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/6/division/6.1
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/4/division/1
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/5.2
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/6.3.2
uri:annex/v/division/8
This Annex sets out the labelling requirements for EU fertilising products....
An EU fertilising product shall consist solely of component materials complying...
The component materials, and the input materials used to produce...
Scope
Definitions
Free movement
Product requirements
Making available on the market
Presumption of conformity
Common specifications
Conformity assessment procedures
General principles of CE marking
Rules and conditions for affixing the CE marking
End-of-waste status
Notification
Notifying authorities
Requirements relating to notifying authorities
Information obligation on notifying authorities
Presumption of conformity of notified bodies
Application for notification
Notification procedure
Identification numbers and lists of notified bodies
Changes to notifications
Challenge of the competence of notified bodies
Appeal against decisions of notified bodies
Exchange of experience
Union market surveillance and control of EU fertilising products entering the Union market
Union safeguard procedure
Formal non-compliance
Amendments of Annexes
Separate delegated acts for separate component material categories
Exercise of the delegation
Committee procedure
Amendments to Regulation (EC) No 1069/2009
Amendments to Regulation (EC) No 1107/2009
Penalties
Report
Biodegradability review
Repeal of Regulation (EC) No 2003/2003
Transitional provisions
Entry into force and application
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