- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
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
There are outstanding changes not yet made to Commission Implementing Regulation (EU) No 354/2013. Any changes that have already been made to the legislation appear in the content and are referenced with annotations.
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
An administrative change of a product is a change following which any change of the existing authorisation can be expected to be only administrative within the meaning of Article 3(1)(aa) of Regulation (EU) No 528/2012.
An administrative change of a product requiring prior notification before implementation is an administrative change, the knowledge of which is important for purposes of control and enforcement. Such changes include those listed in the following table, provided that the conditions therein are met:
Name of the biocidal product | |
---|---|
1. | Changes of the name of the biocidal product where there is no risk of confusion with the names of other biocidal products. |
2. | Addition of a name for the biocidal product where there is no risk of confusion with the names of other biocidal products. |
Authorisation holder | |
3. | Transfer of the authorisation to a new holder established in the European Economic Area (EEA). |
4. | Change in the name or address of the authorisation holder, which remains in the EEA. |
Manufacturer(s) of the active substance(s) | |
5. | Addition of a manufacturer of the active substance or change in the manufacturer’s identity or in manufacturing location or process, where the technical equivalence between the substances from the two manufacturers, manufacturing locations and processes has been established by the Agency in accordance with Article 54 of Regulation (EU) No 528/2012, and the manufacturer or importer is listed in accordance with Article 95(2) of Regulation (EU) No 528/2012. |
Biocidal product family | |
6. | Authorisation as a biocidal product family of a number of authorised products falling within the specifications of a frame-formulation established in accordance with Directive 98/8/EC in accordance with the same terms and conditions. |
An administrative change of a product which can be notified after implementation is an administrative change, the knowledge of which is not important for purposes of control and enforcement. Such changes include those listed in the following table, provided that the conditions therein are met:
Authorisation holder | |
---|---|
1. | Change in other administrative details of the authorisation holder than the name and address. |
Formulator(s) of the biocidal product | |
2. | Change in the name, the administrative details or the formulating location of the biocidal product formulator, where the biocidal product composition and the formulating process remain unchanged. |
3. | Deletion of a formulating location or a formulator of the biocidal product |
4. | Addition of a formulator of the biocidal product, where the biocidal product composition and the formulating process remain unchanged. |
Manufacturer(s) of the active substance(s) | |
5. | Change in the name or the administrative details of a manufacturer of the active substance, where the manufacturing location and process remain unchanged and the manufacturer remains listed in accordance with Article 95(2) of Regulation (EU) No 528/2012 |
6. | Deletion of a manufacturer or a manufacturing location of the active substance |
Conditions of use | |
7. | More precise instructions for use, where only wording but not content of instructions are changed. |
8. | Removal of a particular claim, such as a specific target organism or a specific use. |
9. | Removal of a category of users. |
10. | Addition, replacement or modification of a measuring or administration device not relevant for the risk assessment and not regarded as a risk mitigation measure. |
Classification and labelling | |
11. | Change to the classification and labelling, where the change is limited to what is necessary to comply with newly applicable requirements of Regulation (EC) No 1272/2008 of the European Parliament and of the Councila. |
A minor change of a product is a change, following which any change of the existing authorisation can be expected to be minor within the meaning of Article 3(1)(ab) of Regulation (EU) No 528/2012, since the change of the product is not expected to affect the conclusion with regard to the fulfilment of the conditions of Article 19 or 25 of that Regulation. Such changes include the changes listed in the following table, provided that the conditions therein are met:
Composition | |
---|---|
1. | Increase or reduction, addition, deletion or replacement of a non-active substance intentionally incorporated in the product, where:
|
2. | Increase, reduction, addition or deletion, or replacement of a non-active substance intentionally incorporated in a biocidal product family outside the authorised range, where:
|
Conditions of use | |
3. | Changed instructions for use, where the changes do not adversely affect the exposure |
4. | Addition, replacement or modification of a measuring or administration device relevant for the risk assessment and regarded as a risk mitigation measure, where:
|
Shelf-life and conditions of storage | |
5. | Change in the shelf-life. |
6. | Change in the conditions of storage |
Pack size | |
7. | Change in the pack size range, where:
|
A major change of a product is a change, following which any change of the existing authorisation can be expected to be major within the meaning of Article 3(1)(ac) of Regulation (EU) No 528/2012, since the change of the product can be expected to affect the conclusion with regard to the fulfilment of the conditions of Article 19 or 25 of that Regulation.
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.
Rhychwant ddaearyddol: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Dangos Llinell Amser Newidiadau: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Mae’r llinell amser yma yn dangos y fersiynau gwahanol a gymerwyd o EUR-Lex yn ogystal ag unrhyw fersiynau dilynol a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig.
Cymerir dyddiadau fersiynau’r UE o ddyddiadau’r dogfennau ar EUR-Lex ac efallai na fyddant yn cyfateb â’r adeg pan ddaeth y newidiadau i rym ar gyfer y ddogfen.
Ar gyfer unrhyw fersiynau a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig, bydd y dyddiad yn cyd-fynd â’r dyddiad cynharaf y daeth y newid (e.e. ychwanegiad, diddymiad neu gyfnewidiad) a weithredwyd i rym. Am ragor o wybodaeth gweler ein canllaw i ddeddfwriaeth ddiwygiedig ar Ddeall Deddfwriaeth.
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys