IDENTIFY BPR REQUIREMENTS FULFILL BPR OBLIGATIONS

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Presentation transcript:

IDENTIFY BPR REQUIREMENTS FULFILL BPR OBLIGATIONS Flow Chart 4.0 Step-By-Step Navigator CHAPTER 4.8 Maintain Records END OF PROCESS Identify a Substance / Mixture Identify an Article CHAPTER 4.7 Provide Further Information to Customers CHAPTER 4.1 Identify Biocidal Product / Treated Article CHAPTER 4.2 Identify Product-Type CHAPTER 4.3 Identify Roles and Obligations CHAPTER 4.4 Check AS Status / Transitional Measures CHAPTER 4.5 Substitute/Eliminate AS as required CHAPTER 4.6 Label BP & TA as Required IDENTIFY BPR REQUIREMENTS FULFILL BPR OBLIGATIONS Label a BP See Flow Chart 4.4.1 Label a TA Use a BP See Flow Chart 4.4.2 See Flow Chart 4.4.4 Use an In Situ BP Market a TA See Flow Chart 4.1.1 See Flow Chart 4.1.2 See Flow Chart 4.6.2 See Chapter 4.6.1 Product is an “Article” under REACH? YES NO  Chapter 2.1, “Article”, “Substance”, “Mixture”

Flow Chart 4.1.1 END OF PROCESS Identify BP / TA – REACH Articles Product is neither BP nor TA (Out of scope of BPR) Product is Treated Article with biocidal property or biocidal function Product is Biocidal Product Does finished product intentionally incorporate biocidal product? Does product have a biocidal property or function relevant to finished product? Does product have a primary biocidal function? YES NO  Chapter 2.1, “Intentionally Incorporating”  Chapter 2.1, “Biocidal Property”, “Biocidal Function”  Chapter 2.1, “Primary biocidal function” Is finished product treated “short-term” with biocidal product? Product is Treated Article without biocidal function  Chapter 2.1, “Treated with” Go to Chapter 4.2 END OF PROCESS used to generate active substance(s)? Product is Biocidal Product for generation of in situ active substance(s)  Chapter 2.1, “In situ generated active substances”

Flow Chart 4.1.2 END OF PROCESS BP / TA Identification: Substances & Mixtures Product is Biocidal Product Product is Treated Article Product is neither BP nor TA (Out of scope of BPR) Does product contain AS and have biocidal function rel- evant to finished product? Is product treated with, or does it intentionally incorporate, biocidal product? YES NO  Chapter 2.1, “Biocidal function”  Chapter 2.1, “Intentionally Incorporating”, “Treated with” Is Active Substance generated “in situ” from precursors?  Chapter 2.1, “In situ generated active substances” Precursor combination is Biocidal Product END OF PROCESS Go to Chapter 4.2

AS may be used in BPs for all PTs Flow Chart 4.4.1 Use a Biocidal Product NO YES  Chapter 4.4.5 Is AS/PT approved on the Union List? Is supplier listed for the AS/PT combination on the Article 95 List?  Chapter 4.4.10  Chapter 4.4.6 Was AS/PT in the Review Programme before 1 Sep 2016? AS may be used for the specified PT (pending approval decision if AS/PT is in the Review Programme)  Chapter 4.4.4 Is AS on the Annex I list under Categories 1 to 5 or 7? AS may be used in BPs for all PTs AS may not be used in a BP since1 Sept 2015, unless a new approval application is approved Go to Chapter 4.5 under Category 6?

TA may be marketed without time limit Is AS listed in BPR Annex I? NO YES  Chapter 4.4.4 TA may be marketed without time limit TA may not be marketed after 1 Mar 2017, unless a new application is approved Flow Chart 4.4.3 Market a Treated Article TA may be marketed, pending approval decision  Chapter 4.4.5  Chapter 4.4.8  Chapter 4.4.6 Is non-approval decision on the AS/PT made after 1 Sep 2016? Is AS/PT in the Review Programme before 1 Sep 2016? Is AS approved on the Union List for the relevant PT? TA may not be marketed after 180 days after non-approval decision, unless a new application is approved Is a non-approval decision on the AS/PT made before 1 Sep 2016? Go to Chapter 4.5

Treated Article: Labelling Obligations Flow Chart 4.6.2 Treated Article: Labelling Obligations Is a claim made regarding the biocidal properties of the TA? Does an AS used require labelling as a condition of approval? NO YES  Chapter 2.1, “Claim”  Chapter 4.6.4 Does the TA intentionally incorporate a Biocidal Product?  Chapter 4.6.3 Provide labelling that includes : Statement that the TA incorporates biocidal products Names of all active substances contained in the biocidal products Names of all nanomaterials contained in the biocidal products; Relevant instructions and any precautions for use.  Chapter 4.6.5 Has a biocidal property of the TA been substantiated? TA may be placed on the market without labelling Include on labelling: Biocidal property attributed to the treated article TA may be placed on the market with labelling Go to Chapter 4.7