Flow Chart 4 0 StepByStep Navigator CHAPTER 4

Flow Chart 4. 0 Step-By-Step Navigator CHAPTER 4. 1 Identify Biocidal Product / Treated Article IDENTIFY BPR REQUIREMENTS YES Identify an Article See Flow Chart 4. 1. 1 Product is an “Article” under REACH? Chapter 2. 1, “Article”, “Substance”, “Mixture” Identify a Substance / Mixture NO See Flow Chart 4. 1. 2 CHAPTER 4. 2 Identify Product-Type CHAPTER 4. 3 Identify Roles and Obligations CHAPTER 4. 4 Check AS Status / Transitional Measures Use a BP See Flow Chart 4. 4. 1 Use an In Situ BP See Flow Chart 4. 4. 2 Market a TA See Flow Chart 4. 4. 4 FULFILL BPR OBLIGATIONS CHAPTER 4. 5 Substitute/Eliminate AS as required CHAPTER 4. 6 Label BP & TA as Required CHAPTER 4. 7 Provide Further Information to Customers CHAPTER 4. 8 Maintain Records END OF PROCESS Label a BP Label a TA See Chapter 4. 6. 1 See Flow Chart 4. 6. 2

Flow Chart 4. 1. 1 Identify BP / TA – REACH Articles Product is Biocidal Product for generation of in situ active substance(s) YES Is finished product used to generate active substance(s)? NO Chapter 2. 1, “In situ generated active substances” Product is Treated Article without biocidal function YES Is finished product treated “short-term” with biocidal product? NO Chapter 2. 1, “Treated with” YES Does finished product intentionally incorporate biocidal product? NO Product is neither BP nor TA (Out of scope of BPR) Chapter 2. 1, “Intentionally Incorporating” END OF PROCESS YES Does product have a biocidal property or function relevant to finished product? NO Chapter 2. 1, “Biocidal Property”, “Biocidal Function” Product is Biocidal Product YES Does product have a primary biocidal function? Chapter 2. 1, “Primary biocidal function” Go to Chapter 4. 2 NO Product is Treated Article with biocidal property or biocidal function

Flow Chart 4. 1. 2 BP / TA Identification: Substances & Mixtures Precursor combination is Biocidal Product YES Is Active Substance generated “in situ” from precursors? NO Chapter 2. 1, “In situ generated active substances” Product is Biocidal Product YES Does product contain AS and have biocidal function relevant to finished product? NO Chapter 2. 1, “Biocidal function” YES Product is Treated Article Is product treated with, or does it intentionally incorporate, biocidal product? NO Product is neither BP nor TA (Out of scope of BPR) Chapter 2. 1, “Intentionally Incorporating ”, “Treated with” Go to Chapter 4. 2 END OF PROCESS

Flow Chart 4. 4. 1 Use a Biocidal Product NO Is AS on the Annex I list under Categories 1 to 5 or 7? YES AS may be used in BPs for all PTs Chapter 4. 4. 4 NO Is AS on the Annex I list under Category 6? YES Chapter 4. 4. 4 NO Is AS/PT approved on the Union List? YES Chapter 4. 4. 5 NO Was AS/PT in the Review Programme before 1 Sep 2016? YES Chapter 4. 4. 6 NO Is supplier listed for the AS/PT combination on the Article 95 List? YES AS may be used for the specified PT (pending approval decision if AS/PT is in the Review Programme) Chapter 4. 4. 10 AS may not be used in a BP since 1 Sept 2015, unless a new approval application is approved Go to Chapter 4. 5

Flow Chart 4. 4. 3 Market a Treated Article NO Is AS listed in BPR Annex I? YES Chapter 4. 4. 4 NO Is AS approved on the Union List for the relevant PT? TA may be marketed without time limit YES Chapter 4. 4. 5 YES Is AS/PT in the Review Programme before 1 Sep 2016? NO Chapter 4. 4. 6 NO Is a non-approval decision on the AS/PT made before 1 Sep 2016? TA may not be marketed after 1 Mar 2017, unless a new application is approved YES Chapter 4. 4. 8 NO Is non-approval decision on the AS/PT made after 1 Sep 2016? YES TA may not be marketed after 180 days after non-approval decision, unless a new application is approved Chapter 4. 4. 8 TA may be marketed, pending approval decision Go to Chapter 4. 5

Flow Chart 4. 6. 2 Treated Article: Labelling Obligations NO Does the TA intentionally incorporate a Biocidal Product? YES Chapter 4. 6. 3 NO Is a claim made regarding the biocidal properties of the TA? YES Chapter 2. 1, “Claim” NO Does an AS used require labelling as a condition of approval? YES 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. 4 NO Has a biocidal property of the TA been substantiated? YES Include on labelling: • Biocidal property attributed to the treated article Chapter 4. 6. 5 TA may be placed on the market with labelling TA may be placed on the market without labelling Go to Chapter 4. 7
- Slides: 6