- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Mae unrhyw newidiadau sydd wedi cael eu gwneud yn barod gan y tîm yn ymddangos yn y cynnwys a chyfeirir atynt gydag anodiadau.Ar ôl y diwrnod ymadael bydd tair fersiwn o’r ddeddfwriaeth yma i’w gwirio at ddibenion gwahanol. Y fersiwn legislation.gov.uk yw’r fersiwn sy’n weithredol yn y Deyrnas Unedig. Y Fersiwn UE sydd ar EUR-lex ar hyn o bryd yw’r fersiwn sy’n weithredol yn yr UE h.y. efallai y bydd arnoch angen y fersiwn hon os byddwch yn gweithredu busnes yn yr UE. EUR-Lex Y fersiwn yn yr archif ar y we yw’r fersiwn swyddogol o’r ddeddfwriaeth fel yr oedd ar y diwrnod ymadael cyn cael ei chyhoeddi ar legislation.gov.uk ac unrhyw newidiadau ac effeithiau a weithredwyd yn y Deyrnas Unedig wedyn. Mae’r archif ar y we hefyd yn cynnwys cyfraith achos a ffurfiau mewn ieithoedd eraill o EUR-Lex. The EU Exit Web Archive legislation_originated_from_EU_p3
EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
Granting, review and withdrawal of authorizations of plant protection products
REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE INCLUSION OF AN ACTIVE SUBSTANCE IN ANNEX I
2. Physical and chemical properties of the active substance
2.3. Vapour pressure (in Pa), volatility (e.g. Henry's law constant)
2.4. Appearance (physical state, colour and odour; if known)
2.5. Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths...
2.6. Solubility in water including effect of pH (4 to 10)...
2.8. Partition coefficient n-octanol/water including effect of pH (4 to 10)...
2.9. Stability in water, hydrolysis rate, photochemical degradation, quantum yield and...
2.10. Stability in air, photochemical degradation, identity of breakdown product(s)
3. Further information on the active substance
3.1. Function, e.g. fungicide, herbicide, insecticide, repellant, growth regulator
3.2. Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach...
3.3. Field of use envisaged, e.g. field, protected crops, storage of...
3.4. Harmful organisms controlled and crops or products protected or treated...
3.6. Information on the occurrence or possible occurrence of the development...
3.7. Recommended methods and precautions concerning handling, storage, transport or fire...
5. Toxicological and metabolism studies
5.1. Studies on absorption, distribution, excretion and metabolism in mammals
5.9.1. Medicinal surveillance on manufacturing plant personnel
5.9.2. Direct observation, e.g.: clinical cases and poisoning incidents
5.9.3. Observations on exposure of the general population and epidemiological studies...
5.9.4. Diagnosis of poisoning (determination of active substance, metabolites), specific signs...
5.9.5. Proposed treatment: first aid measures, antidotes, medical treatment
6. Residues in or on treated products, food and feed
6.1. Metabolism, distribution and expression of residue in plants
6.2. Metabolism, distribution and expression of residue in livestock
6.5. Effects of industrial processing and/or household preparations
6.7. Proposed maximum residue levels (MRLs) and residue definiton
6.8. Proposed pre-harvest intervals for envisaged uses, or withholding periods or...
6.9. Estimation of the potential and actual exposure through diet and...
10. Proposals including justification for the proposals for the classification and...
8. Effects on non-target organisms
REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE AUTHORIZATION OF A PLANT PROTECTION PRODUCT
1. Identity of the plant protection product
1.2. Manufacturer of the preparation and the active substance(s) (names and...
1.3. Trade name or proposed trade name, and manufacturer's development code...
1.4. Detailed quantitative and qualitative information on the composition of the...
1.5. Physical state and nature of the preparation (emulsifiable concentrate, wettable...
2. Physical, chemical and technical properties of the plant protection product...
2.3. Flash point and other indications of flammability or spontaneous ignition...
2.7. Storage — stability and shelf-life: Effects of light, temperature and...
2.8. Technical characteristics of the plant protection product
2.9. Physical and chemical compatibility with other products including plant protection...
2.11. Summary and evaluation of data presented under points 2.1. to...
3.1. Field of use envisaged, e.g. field, protected crops, storage of...
3.2. Effects on harmful organisms, e.g. contact, inhalation or stomach poison,...
3.3. Details of intended use e.g. types of harmful organisms controlled...
3.5. Concentration of active substance in material used (e.g. in the...
3.7. Number and timing of applications and duration of protection
3.8. Necessary waiting periods or other precautions to avoid phytotoxic effects...
4. Further information on the plant protection product
4.1. Packaging (type, materials, size etc.), compatibility of the preparation with...
4.3. Re-entry periods, necessary waiting periods or other precautions to protect...
4.4. Recommended methods and precautions concerning: handling, storage, transport or fire...
4.6. Procedures for destruction or decontamination of the plant protection product...
6.3. Information on the occurrence or possible occurrence of the development...
6.4. Effects on the yield of treated plants or plant products...
6.5. Phytotoxicity to target plants (including different cultivars), or to target...
6.6. Observations on undesirable or unintended side-effects, e. g. on beneficial...
6.7. Summary and evaluation of data presented under 6.1 to 6.6...
8. Residues in or on treated products, food and feed
8.1. Metabolism, distribution and expression of residue in plants or livestock...
8.4. Effects of industrial processing and/or household preparations
8.6. Proposed maximum residue levels (MRLs) and residue definition
8.7. Proposed pre-harvest intervals for envisaged uses, or withholding periods or...
8.8. Estimation of the potential and actual exposure through diet and...
9. Fate and behaviour in the environment
2. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT...
2.4. Flash point and other indications of flammability or spontaneous ignition...
2.7. Technical characteristics of the plant protection product
2.8. Physical, chemical and biological compatibility with other products including plant...
2.10. Summary and evaluation of data presented under points 2.1 to...
4. FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT
4.1. Packaging and compatibility of the preparation with proposed packaging materials...
4.3. Re-entry periods, necessary waiting periods or other precautions to protect...
4.4. Recommended methods and precautions concerning: handling, storage, transport or fire...
4.6. Procedures for destruction or decontamination of the plant protection product...
STANDARD PHRASES FOR SPECIAL RISKS FOR HUMANS OR THE ENVIRONMENT AS REFERRED TO IN ARTICLE 16
3. Attribution criteria for standard phrases for specific safety precautions
3.2. Attribution criteria for standard phrases for safety precautions for operators...
3.3. Attribution criteria for standard phrases for safety precautions for the...
3.4. Attribution criteria for standard phrases for safety precautions for good...
3.5. Attribution criteria for standard phrases for specific safety precautions for...
PART I UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF CHEMICAL PLANT PROTECTION PRODUCTS
1.1. Having regard to current scientific and technical knowledge, Member States...
1.2. The quality/methodology of tests, where there are no standardised test...
1.3. In interpreting the results of evaluations, Member States shall take...
1.7. Where specific principles in Section 2 provide for the use of...
2.2. Biological, physical, chemical, and technical properties
2.4.3. Member States shall evaluate the efficacy data provided for in...
2.4.4. Member States shall evaluate the performance of the plant protection...
2.4.5. Member States shall evaluate the degree of adverse effects on...
2.4.6. Where the plant protection product label includes requirements for use...
2.4.8. Where the proposed use of a plant protection product is...
2.6. Impact on human or animal health
2.6.1. Effects on human or animal health arising from the plant...
2.6.1.1. Member States shall evaluate operator exposure to the micro-organism, and/or...
2.6.1.2. Member States shall examine information relating to the nature and...
2.6.1.3. Member States shall examine the nature and characteristics of the...
2.6.1.4. Member States shall evaluate the possibility of exposure of other...
2.6.2. Effects on human or animal health arising from residues
2.8. Effects on and exposure of non-target organisms
2.8.1. Member States shall evaluate the possibility of exposure of and...
2.8.2. Member States shall evaluate the possibility of exposure of and...
2.8.3. Member States shall evaluate the possibility of exposure of and...
2.8.4. Member States shall evaluate the possibility of exposure of and...
2.8.5. Member States shall evaluate the possibility of exposure of and...
2.8.6. Member States shall evaluate the possibility of exposure of and...
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Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE): Mae'r wreiddiol version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
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