DBP Consortium. Halogenated active substances and products ARROW REGULATORY LIMITED 6 TH FLOOR CITY GATE EAST TOLL HOUSE HILL NOTTINGHAM NG1 5FS
|
|
- Cecil Hudson
- 6 years ago
- Views:
Transcription
1 DBP Consortium Halogenated active substances and products ARROW REGULATORY LIMITED 6 TH FLOOR CITY GATE EAST TOLL HOUSE HILL NOTTINGHAM NG1 5FS
2 Contents What are Disinfection By-Products (DBP)? Why are DBPs important to biocide product authorisation? Why form a consortium? What is the consortium doing? Where are we now? 2
3 What are DBPs? A chemical compound formed by the reaction of a water disinfectant (e.g. chlorine) with a precursor (e.g. natural organic matter) in a water supply. The most commonly known DBPs are those formed with halogens, e.g. chlorine and bromine. Any disinfectant can form DBPs during use, including free radicals and ozone. All natural water sources contain halogens. All potable water contains DBPs 3
4 What are DBPs? From halogenated disinfectants Trihalometanes (THMs) Haloacetic acids (HAAs) Haloaldehydes Haloacetonitriles Haloamines Chlorate/bromate From ozonation formaldehyde and other aldehydes, carboxylic acids hydrogen peroxide bromate bromomethanes brominated acetic acids brominated acetonitriles and ketones 4
5 DBPs and the BPR ECHA Guidance Document Volume V: Guidance on Disinfection By- Products. Jan 2017 The disinfection of water with oxidising biocides leads to the formation of by-products (DBPs). According to the Biocides Product Regulation (BPR), the effect of residues should be evaluated in the risk assessment (see e.g. Art. 19,(1)(b)(iii)) and according to the definition in Art. 3,(1)(h), residues include reaction products. A number of known (groups of) DBPs are biologically active, and some are (suspected) carcinogens or mutagens (e.g. chloroform, halogenated methanes, bromate). Moreover, most DBPs are more stable than the biocide itself. Therefore, a risk assessment of DBPs as part of the authorisation of biocidal products is necessary. 5
6 DBP Guidance Strategy for the evaluation of DBPs - Proposed methodology for assessment Included: Halogenated active substances (oxidisers) Identification of marker substances PT 2, swimming pool disinfectants and PT 11 and 12 preservatives a tentative list of PT for which DBP assessment is relevant It does not exclude: Risk assessment for all PT where DBP may be formed Any other reactive active substance that may form DBP 6
7 Risk v benefit of disinfection; a balance The risk of waterborne infectious disease is very high when no chlorination is used, and drops sharply to a low value when even minimal levels of chlorination are maintained. We know this on the basis of a century's experience. Morris 1978 the risk of death from pathogens is at least 100 to 1000 times greater than the risk of cancer from disinfection byproducts (DBPs); the risk of illness from pathogens is at least to 1 million times greater than the risk of cancer from DBPs; morbidity and mortality rates from pathogens compared with those from DBPs, may be considerably higher in developing countries where the sanitary and health status is not as good; in societies where infant mortality and life expectancy is low, many people would not be expected to live long enough to incur cancer, which also causes much higher differences in risk resulting from exposure to pathogens versus DBPs cited above. Regli et al. (1993) 7
8 DBP s and the BPR World Health Organisation: Adequate disinfection of drinking-water is the most important priority to assure a safe water supply. BPR Authorisation may be granted if the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects (Art 19 1(b) (iii)) A biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public when the criteria referred to in paragraph 4(c) are met, where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation. 8
9 DBP s and the BPR BPR places onus on product manufacturers to identify the application range where risk/benefit is maximised for their products. The BPR cannot force end-users to; use products in accordance with label claim monitor DBP formation and take steps to ensure limits are adhered to. Measurements must be applied via other legal statutes (EU and National). 9
10 BPR Active substance applications; Substance manufacturers Representative product, often dummy product Default models for risk assessment Generic use patterns Product authorisation Substance manufacturers, formulators or distributors Real products All uses Application dose defined by efficacy studies Deficiencies: Efficacious dose vs DBP formation Lack of incentive for end-user of products to buy-in to product approval scheme 10
11 Why form a Consortium? Cost Duplication of work Harmonisation/concensus across industry Pooling of knowledge Raising end-user awareness of BPR and it s impact on their business Influencing end-users to become involved, sharing of data 11
12 DBP Consortium Limited to halogenated active substances and products Open to active substance manufacturers and any company placing halogenated products on the market. Currently 95 members and 11 companies in the process of joining Entry to late-joining members open Steering Committee and Technical Committee Independent experts 12
13 Scope of work Chlorinated and brominated substances; Sodium and calcium hypochlorite Chlorine Active chlorine and Active bromine Chlorine dioxide Monochloramine Chlorinated isocyanurates; TCCA, NaDCC anhydrous and dihydrate Halohydantoins (e.g. BCDMH) Product Types (halogenated products); PT 1 5 PT 11 and 12 13
14 Aim A harmonised standard for both chlorinated and brominated biocidal products, i.e. a worst case DBP profile for each disinfectant/preservative use will be identified and assessed for safety. This will lead to the production of a list of label claims (dosing regime and application conditions) that lead to a safe use, in respect to DBP generation, that applicants can reference for their own authorisations. 14
15 Work Plan Phase 1: Data Collection Phase 2: Expert Assessment Exposure/release data Hazard determination Relevance of marker or groups of DBP Phase 3: Data Gap Assessment Phase 4: Data Generation Phase 5: Risk Assessment and Report on Safe Conditions of Use Report due date: Oct
16 Where are we now? Phase 1: Data Collection Phase 2: Expert Assessment Data Gap Analysis Study planning 16
17 Sara Kirkham WEBSITE: ARROWREGULATORY.COM TELEPHONE (+44) (0)
DISINFECTION BY-PRODUCTS (DBPS) IN DRINKING WATER AND THEIR ASSOCIATED HEALTH RISK: A REVIEW
DISINFECTION BY-PRODUCTS (DBPS) IN DRINKING WATER AND THEIR ASSOCIATED HEALTH RISK: A REVIEW F. Khan & M. F. R Zuthi * Department of Civil Engineering, Chittagong University of Engineering and Technology,
More informationChlorinated Disinfection By-Products (CDBPs) Prepared for the CDBP Task Group
Chlorinated Disinfection By-Products (CDBPs) Prepared for the CDBP Task Group Introduction The goal of water disinfection is the inactivation of microorganisms, such as viruses, bacteria and protozoa,
More informationScientific Facts on. Water Disinfectants. & disinfectant by-products
page 1/13 Scientific Facts on Water Disinfectants & disinfectant by-products Source document: IPCS (2000) Summary & Details: GreenFacts Level 2 - Details on Water Disinfectants 1. What disinfectants and
More informationGuidance on the Biocidal Products Regulation
G U I D A N C E Guidance on the Biocidal Products Regulation Volume V, Guidance on Disinfection By-Products Version 1.0 January 2017 2 Version 1.0 January 2017 LEGAL NOTICE This document aims to assist
More informationRisk Assessment and Characterization of Chloroform and Other Disinfection Byproducts
Risk Assessment and Characterization of Chloroform and Other Disinfection Byproducts Jeffrey Sloan Chlorine Chemistry Council WCC Congress on Science Buenos Aires, Argentina Overview History of chlorine
More informationBiocidal Products Committee (BPC)
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Active chlorine released from calcium hypochlorite Product type: 4 ECHA/BPC/134/2016 Adopted 14 December
More informationBiocidal Products Committee (BPC)
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: L(+) lactic acid Product type: 2 ECHA/BPC/147/2017 Adopted 27 April 2017 Annankatu 18, P.O. Box 400, FI-00121
More informationBiocidal Products Committee (BPC)
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Salicylic acid Product type: 4 ECHA/BPC/189/2018 6 March 2018 Annankatu 18, P.O. Box 400, FI-00121 Helsinki,
More informationBiocidal Products Committee (BPC)
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Salicylic acid Product type: 2 ECHA/BPC/187/2018 6 March 2018 Annankatu 18, P.O. Box 400, FI-00121 Helsinki,
More informationNitrogenous Disinfection By-Products Formation Potential from Molecular Weight Fractions of Natural Organic Matter
Nitrogenous Disinfection By-Products Formation Potential from Molecular Weight Fractions of Natural Organic Matter Ina Kristiana, Jace Tan, Suzanne McDonald, Rino Trolio, Cynthia Joll, Anna Heitz and Jeffrey
More informationBiocidal Products Committee (BPC)
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Hydrated lime Product type: 2 ECHA/BPC/100/2016 Adopted 14 April 2016 Annankatu 18, P.O. Box 400, FI-00121
More informationTrisodium nitrilotriacetate (NTA)
RISK MANAGEMENT OPTIONS ANALYSIS CONCLUSION DOCUMENT for Trisodium nitrilotriacetate (NTA) EC No 225-768-6 CAS No 5064-31-3 Member State: Denmark Dated: August 2014, Final version Disclaimer: Please note
More informationBiocidal Products Committee (BPC)
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: OIT Product type: 8 ECHA/BPC/139/2016 Adopted 15 December 2016 Annankatu 18, P.O. Box 400, FI-00121 Helsinki,
More informationScience Dossier. Human health aspects of halogenated organic by-products from use of active chlorine
Science Dossier Human health aspects of halogenated organic by-products from use of active chlorine January 2017 This publication is the seventeenth in a series of Science Dossiers providing the scientific
More informationThe regulatory landscape. The now and the not yet
The regulatory landscape The now and the not yet Perspectives Aims Promote common understanding Anticipate the coming changes Prepare for afternoon sessions Who governs pesticides? All EU legislation comes
More informationSpecial Report: How Your Shower May Be Hazardous To Your Health! By Joel Kaye, MA
Special Report: How Your Shower May Be Hazardous To Your Health! By Joel Kaye, MA www.rightbraindiet.com It's funny how people are always concerned with drinking filtered water, when in fact you absorb
More informationRisk Assessment Report on Chlorine. Human Health Part. CAS No.: EINECS No
Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on Chlorine Human Health Part CAS No.: 7782-50-5 EINECS No. 231-959-5 The SCHER adopted this opinion at its 22 nd plenary
More informationRestrictions in the use of biocides for disinfection procedures
Restrictions in the use of biocides for disinfection procedures Peter Oltmanns, PhD Susanne Hendrich, PhD Research and Development the plus of pure performance Conclusion of previous presentation Effective
More informationRisk of Birth Defects in Australian Communities with High Levels of Brominated Disinfection By-products
Risk of Birth Defects in Australian Communities with High Levels of Brominated Disinfection By-products Kimberly Chisholm, Angus Cook, Carol Bower, & Philip Weinstein Environmental Health Perspectives
More informationRecent Developments and Future Plans in the EFSA Assessments of Pesticides. Hermine Reich Pesticides Unit
Recent Developments and Future Plans in the EFSA Assessments of Pesticides Hermine Reich Pesticides Unit Pesticides Unit and Panel activities Scientific Panel on Plant Protection Product and their Residues
More informationChapter 6 Physical and chemical quality of drinking water
Chapter 6 Physical and chemical quality of drinking water Chapter 6 Physical and Chemical Quality of Drinking Water Chapter 6 Chapter 6 Physical and chemical quality of drinking water 6.1 Introduction
More informationAeration to remove THMs from drinking water. Ron Hofmann Susan Andrews Arash Zamyadi Hong Zhang
Aeration to remove THMs from drinking water Ron Hofmann Susan Andrews Arash Zamyadi Hong Zhang DBPs: a distribution system issue (too!) Distribution system strategies to minimize DBPs Chlorine chloramines
More informationA Comparison Between Freshwater and Seawater Swimming Pools: From Chemical Profile to Genotoxicity
A Comparison Between Freshwater and Seawater Swimming Pools: From Chemical Profile to Genotoxicity Tarek Manasfi a, Michel De Meo b, Bruno Coulomb a, Carole Di Giorgio b, Jean-Luc Boudenne a a Environmental
More informationStudies Show Link Between Chlorinated Water and Cancer By Apollo Tuesday, January 22nd, 2013
Studies Show Link Between Chlorinated Water and Cancer By Apollo Tuesday, January 22nd, 2013 If you visit the US Environmental Protection Agency (EPA) website and look up Chlorine, you will find under
More informationDanielle Westerman, Hannah K. Liberatore, Kristin H. Cochran Cassiana Montagner, Dion D. Dionysiou, Leslie H. Cizmas, Susan Richardson
Danielle Westerman, Hannah K. Liberatore, Kristin H. Cochran Cassiana Montagner, Dion D. Dionysiou, Leslie H. Cizmas, Susan Richardson Department of Chemistry and Biochemistry University of South Carolina
More informationECPA position paper on the criteria for the determination of endocrine disrupting properties under Regulation
POSITION PAPER 09/06/2016 PP/14/PD/23734 ECPA position paper on the criteria for the determination of endocrine disrupting properties under Regulation The European Commission is currently developing new
More informationQuestions and Answers on Candidates for Substitution
Questions and Answers on Candidates for Substitution Rev. 1, January 2015 Background The European Commission is required by Regulation (EC) No 1107/2009 ( the Regulation ) to establish a list of substances
More informationCEE 697z Organic Compounds in Water and Wastewater
Print version CEE 697z rganic Compounds in Water and Wastewater NM and DBPs Special Lecturer: Rassil El Sayess Lecture #9 http://www.ecs.umass.edu/eve/research/nyc_chloramines/literature.html Dave Reckhow
More informationREACH Authorisation. REACH Conference Bratislava September 3-4, 2018
REACH Conference Bratislava September 3-4, 2018 REACH Authorisation Martin Murín, MSc. Ekotox Centers Ekotoxikologické centrum Bratislava s.r.o. Tomášikova 10/F, 821 03 Bratislava Tel/Fax.: +421 45943712
More informationRisk Assessment Report on sodium hypochlorite Human Health Part. CAS No.: EINECS No
Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on sodium hypochlorite Human Health Part CAS No.: 7681-52-9 EINECS No. 231-668-3 The SCHER adopted this opinion at its
More informationJustification for the selection of a substance for CoRAP inclusion
Justification for the selection of a substance for CoRAP inclusion Substance Name (Public Name): Chemical Group: Aluminium chloride inorganic mono constituent substance EC Number: 231-208-1 CAS Number:
More information1 OJ L 354, , p OJ L 80, , p. 19.
Call for scientific and technical data on the permitted food additives sulphur dioxide (E 220), sodium sulphite (E 221), sodium bisulphite (E 222), sodium metabisulphite (E 223), potassium metabisulphite
More informationEFSA Statement regarding the EU assessment of glyphosate and the socalled
EFSA Statement regarding the EU assessment of glyphosate and the socalled Monsanto papers Background On 29 May 2017, EFSA received a request from the European Commission to produce a statement concerning
More informationPRODUCT INFORMATION SHEET
PRODUCT INFORMATION SHEET FEATURES & APPLICATIONS FOOD SAFE SANITISER Unico Limited, North Main Street, Carronshore, Falkirk. FK2 8HT Tel: 0845 27 86426 Fax: 01324 573401 Unico Food Safe Sanitiser is a
More informationDEGRADATION AND REMOVAL OF TRIHALOMETHANES FROM DRINKING WATER
DEGRADATION AND REMOVAL OF TRIHALOMETHANES FROM DRINKING WATER An Undergraduate Research Scholars Thesis by EVERETT CALEB CLAYCOMB Submitted to the Undergraduate Research Scholars program Texas A&M University
More informationRISK MANAGEMENT OPTION ANALYSIS CONCLUSION DOCUMENT
RISK MANAGEMENT OPTION ANALYSIS CONCLUSION DOCUMENT for Substance name: 2,4,6-trimethyl-2,4,6-tris(3,3,3- trifluoropropyl)cyclotrisiloxane, F-D3 EC number: 219-154-7 CAS number: 2374-14-3 Member State(s):
More informationGLP in the European Union Ecolabel detergents, GLP and accreditation
GLP in the European Union Ecolabel detergents, GLP and accreditation Maik Schmahl Brussels, 25/03/2010 Chemicals Unit Outline What is GLP? How has it developed? The role of the Member States, the European
More informationFoodDrinkEurope Position on GLP studies
FoodDrinkEurope Position on GLP studies Content of the presentation Introduction to GLP Importance of GLP for the food industry Use of GLP based on the example of novel foods Conclusions GLP what is it?
More informationIntroduction. Doc-Biocides-2002/01 Version
Doc-Biocides-2002/01 Version 08.01.2008 Guidance document agreed between the Commission services and the competent authorities of the Member States for the Biocidal Products Directive 98/8/EC and for the
More informationHealth & Consumer Protection. EC legislation on food. Olga Solomon Unit E3
Health & Consumer Protection Directorate-General EC legislation on food additives Olga Solomon Unit E3 1 What is a food additive? Food additives are substances: not normally consumed as food or a characteristic
More informationSection 1: Identification of the substance or mixture and the company
Section 1: Identification of the substance or mixture and the company 1.1. Product Identifier Name: Solid Zinc (Zn) in various manufactured forms EC #: 231-175-3 CAS #: 7440-66-6 1.2 Relevant applications
More informationSafety Assessment of Hypobromous Acid (220 ppm as Br 2 ) Used as a Beef Carcass Wash
Safety Assessment of Hypobromous Acid (220 ppm as Br 2 ) Used as a Beef Carcass Wash Prepared for: Enviro Tech Chemical Services Modesto, CA Prepared by: Duncan Turnbull, DPhil, DABT Senior Science Advisor
More informationSubstance Evaluation Conclusion document EC No SUBSTANCE EVALUATION CONCLUSION DOCUMENT. as required by REACH Article 48.
SUBSTANCE EVALUATION CONCLUSION DOCUMENT as required by REACH Article 48 for Buta-1,3-diene EC No 203-450-8 CAS No 106-99-0 Evaluating Member State(s): Germany 22 October 2015 Evaluating Member State Competent
More informationApplying the Precautionary Principle to Consumer Household Cleaning Product Design
Applying the Precautionary Principle to Consumer Household Cleaning Product Design Cara Bondi, MPH, MS Senior Research Scientist Seventh Generation, Inc. The Toxics Use Reduction Act (TURA) 20 th Anniversary
More informationRPA. Assessment of the Impact of the New Chemicals Policy on Occupational Health. Final Report
Assessment of the Impact of the New Chemicals Policy on Occupational Health Final Report prepared for European Commission Environment Directorate-General RPA March 2003 ASSESSMENT OF THE IMPACT OF THE
More informationEuropean Food Safety Authority (EFSA)
TECHNICAL REPORT APPROVED: 06 April 2017 doi:10.2903/sp.efsa.2017.en-1210 Outcome of the preliminary pesticides peer review meeting on the assessment of endocrine disrupting properties in mammalian toxicology
More informationCOMMISSION REGULATION (EU)
11.3.2011 Official Journal of the European Union L 64/15 COMMISSION REGULATION (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council
More informationWhat is an Infocard? July 2018
What is an Infocard? July 2018 2 What is an Infocard? Disclaimer This publication is solely intended for information purposes and does not necessarily represent the official opinion of the European Chemicals
More informationQuality Assurance Policy. for the. Procurement of HIV Point-of-Care Technology. under the UNITAID Grant
Quality Assurance Policy for the Procurement of HIV Point-of-Care Technology under the UNITAID Grant UNICEF Supply Division Quality Assurance Centre and Health Technology Centre Revisions Version Date
More informationAnnual Epidemiological Report
December 2018 Annual Epidemiological Report Key Facts Cryptosporidium 1 infection in Ireland, 2017 In 2017, 589 cases of cryptosporidiosis were notified in Ireland 36 were hospitalised, with no reported
More informationSurvey results - Analysis of higher tier studies submitted without testing proposals
Survey results - Analysis of higher tier studies submitted without testing proposals Submission of higher tier studies on vertebrate animals for REACH registration without a regulatory decision on testing
More informationGuideline scope Smoking cessation interventions and services
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Topic NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Guideline scope Smoking cessation interventions and services This guideline
More informationGuidelines to Commission Regulation (EU) No 655/2013. laying down common criteria for the justification of claims used
Ref. Ares(2015)5892153-16/12/2015 Version July 2013 Guidelines to Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products
More informationIs Rosin Classifiable as a Skin Sensitiser? Paul Illing
Is Rosin Classifiable as a Skin Sensitiser? Paul Illing SVHC Coordination Group for Human Health With respect to the ELoC (equivalent level of concern) substances, these can be identified on a case-by-case
More informationFÜR RISIKOBEWERTUNG BUNDESINSTITUT
BUNDESINSTITUT FÜR RISIKOBEWERTUNG Legal and Practical Aspects of the Cut-off Criteria for Reproductive Toxic and Endocrine Disrupting Effects for Approval and Classification of Pesticides in Europe Roland
More informationSafe Drinking Water? Effect of Wastewater Inputs and Source Water Impairment and Implications for Water Reuse. Susan D. Richardson
Safe Drinking Water? Effect of Wastewater Inputs and Source Water Impairment and Implications for Water Reuse Susan D. Richardson Safe Drinking Water: What are the Issues? Chemical risk: Exposure to hazardous
More informationPesticide risk assessment: changes and perspectives for mammalian toxicology in the new EC regulation 1107/2009
Pesticide risk assessment: changes and perspectives for mammalian toxicology in the new EC regulation 1107/2009 M.Tiramani Pesticide Risk Assessment Peer Review (PRAPeR) Mammalian toxicology New Pesticide
More informationJustification Document for the Selection of a CoRAP Substance
Justification Document for the Selection of a CoRAP Substance Substance Name (public name): Sodium hydroxymethanesulphinate EC Number: 205-739-4 CAS Number: 149-44-0 Authority: NL MSCA Date: 22/03/2016
More informationAntimicrobial Processing Aids for Which Health Canada Has Issued a Letter of No Objection (LONO) or an interim Letter of No Objection (ilono)
Antimicrobial s for Which Health Canada Has Issued a Letter of No Objection (LONO) or an interim Letter of No Objection (ilono) December 17, 2015 Bureau of Chemical Safety, Food Directorate, Health Products
More informationChemical Name: Complex Chloride Sodium Chloride, Potassium Chloride, Magnesium Chloride, Calcium Chloride
1. PRODUCT AND COMPANY IDENTIFICATION Product Identity: MeltDown Near Zero Chemical Name: Complex Chloride Sodium Chloride, Potassium Chloride, Magnesium Chloride, Calcium Chloride Recommended use of the
More information19 September The Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC)
Annex to ECHA News 1 (6) 19 September 2018 Annex to a news release RAC concludes on 14 opinions for harmonised classification and labelling, RAC and SEAC agree on the restriction proposal for group of
More informationSAFETY DATA SHEET Clinell Antibacterial Hand Wipes According to Regulation (EU) No 453/2010
SECTION 1: Identification of the substance/mixture and company/undertaking 1.1 Product Identifier Product Name 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified
More informationChallenges in environmental risk assessment (ERA) for birds and mammals and link to endocrine disruption (ED) Katharina Ott, BASF SE, Crop Protection
Challenges in environmental risk assessment (ERA) for birds and mammals and link to endocrine disruption (ED) Katharina Ott, BASF SE, Crop Protection Charles River Symposium, Den Bosch, 3rd October 2017
More informationControlling Risk in your Supply Chain - Instruments of Change
1 Controlling Risk in your Supply Chain - Instruments of Change Will Martin E2S2 February 11 Outline Key Risks Associated With Registration 2 Cost of Registration Supply Chain Complexity Downstream Uses
More information1,1 - iminodipropan-2-ol
Possibility for MSCA Logo] SUBSTANCE EVALUATION CONCLUSION DOCUMENT as required by REACH Article 48 for 1,1 - iminodipropan-2-ol EC No 203-820-9 CAS No 110-97-4 Evaluating Member State(s): Czech Republic
More informationJustification for the selection of a candidate CoRAP substance UPDATE
Justification for the selection of a candidate CoRAP substance UPDATE Substance Name (Public Name): Chemical Group: Tetrapropylenebenzene Branched alkylbenzenes EC Number: 246-772-4 CAS Number: 25265-78-5
More informationGood Laboratory Practice. EU-Serbia screening meeting Brussels, 19 June 2014
Good Laboratory Practice EU-Serbia screening meeting Brussels, 19 June 2014 Table of contents 1. Background information on the principles of GLP 2. EU legal basis for GLP 3. Role of Member States 4. Role
More informationRoadmap to review the Nutrition and Health Claims legislation expression of interest to contribute to the upcoming external study
European Commission DG SANTE Directorate-General for Health and Food Safety www.eucope.org Telephone: Telefax: E-Mail: 25 April 2016 Roadmap to review the Nutrition and Health Claims legislation expression
More informationSafety Data Sheet Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH)
Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) This Safety Data Sheet is prepared voluntarily: it is not required according to Article 31 of Regulation (EC) No 1907/2006 Section 1:
More informationWhy the detergent industry relies on a limited number of in-can preservatives
Why the detergent industry relies on a limited number of in-can preservatives Background: in-can preservatives active substances under BPR (PT6) BPR currently allows the use of 50 active substances for
More informationValidation of Relationship Between Free Chlorine Dose and Pathogen Inactivation in Drinking Water
Validation of Relationship Between Free Chlorine Dose and Pathogen Inactivation in Drinking Water Dr Arran Canning Seqwater Satiya Wati, Alex Keegan, Duncan Middleton, Duncan Shillito, Michael Bartkow
More informationFollow-up of the food additive re-evaluation programme by the European Commission
Follow-up of the food additive re-evaluation programme by the European Commission Dr Guillermo Cardon Policy Officer on Food Additives Unit E2: Food Processing Technologies and Novel Foods DG Health and
More informationAssessing and Managing Health Risks from Chemical Constituents and Contaminants of Food
16 17 September 2013 Assessing and Managing Health Risks from Chemical Constituents and Contaminants of Food Workshop on A Framework for Assessing the Health, Environmental and Social Effects of the Food
More informationAnimal testing versus calculation method
Animal testing versus calculation method Dr. Tamara Coja, MSc Toxicology Institute for Plant Protection Products, Department for Toxicology Interzonal workshop Harmonisation of risk assessment in section
More informationEVALUATING OXIVIR TB VERSUS CRITERIA OF IDEAL DISINFECTANTS HOW DOES IT STACK UP?
EVALUATING OXIVIR TB VERSUS CRITERIA OF IDEAL DISINFECTANTS HOW DOES IT STACK UP? Recent studies have demonstrated that the environment plays a role in the transmission of healthcare-associated infections
More informationDraft Guidance for Industry and FDA Staff
Draft Guidance for Industry and FDA Staff Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile DRAFT GUIDANCE This guidance document
More informationCOMMISSION DELEGATED REGULATION (EU).../... of XXX
EUROPEAN COMMISSION Brussels, XXX SANTE/10355/2015 (POOL/E4/2015/10355/10355-EN. doc) [...1(2015) XXX draft COMMISSION DELEGATED REGULATION (EU).../... of XXX supplementmg Regulation (EU) No 609/2013 of
More informationEUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Ref. Ares(2019)290814-18/01/2019 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) 2018-6428 FINAL REPORT OF AN AUDIT CARRIED OUT IN PORTUGAL
More informationEvaluation of active substances in plant protection products Residues Anja Friel European Food Safetey Authority, Parma/ Italy
Evaluation of active substances in plant protection products Residues Anja Friel European Food Safetey Authority, Parma/ Italy European Conference on MRL-Setting for Biocides Berlin, 18-19 March 2014 Legal
More informationFellowes UK Yorkshire Way, West Moor Park Doncaster, South Yorkshire DN3 3FB UK Telephone: + 44 (0) Fax: + 44 (0)
SECTION 1: COMPANY AND PRODUCT IDENTIFICATION Fellowes UK Yorkshire Way, West Moor Park Doncaster, South Yorkshire DN3 3FB UK Telephone: + 44 (0) 1302 836800 Fax: + 44 (0) 1302 836899 Product Name: Description:
More informationBritish American Tobacco Snus Marketing Standards
British American Tobacco Snus Marketing Standards British American Tobacco p.l.c. believes there is sufficient scientific evidence to support a less restrictive regime for the advertising and promotion
More informationPesticide Product Labels What the label says.and Why. Dr. Jeff Birk BASF Corporation Regulatory Manager
Pesticide Product Labels What the label says.and Why Dr. Jeff Birk BASF Corporation Regulatory Manager Regulation of Pesticides The pesticide industry is regulated by the USEPA. The pesticide industry
More informationHuman health risk from trihalomethanes in drinking water evaluation with fuzzy aggregation
Environmental Exposure and Health 299 Human health risk from trihalomethanes in drinking water evaluation with fuzzy aggregation S. Chowdhury & T. Husain Memorial University of Newfoundland, St. John s,
More informationthe EUROPEAN COMMISSION INITIATIVE
ECIBC the EUROPEAN COMMISSION INITIATIVE on BREAST CANCER Livia Giordano GDG Member CPO Piemonte - ITALY Origin of the Initiative Because of "substantial and persistent inequalities in breast cancer incidence,
More informationSubstance Evaluation Conclusion document EC No SUBSTANCE EVALUATION CONCLUSION DOCUMENT. as required by REACH Article 48.
SUBSTANCE EVALUATION CONCLUSION DOCUMENT as required by REACH Article 48 for 2-AMINOETHANOL EC No 205-483-3 CAS No 141-43-5 Evaluating Member State(s): UK Dated: September 2016 Evaluating Member State
More informationCOUNCIL OF THE EUROPEAN UNION. Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DENLEG 51 CODEC 893
COUNCIL OF THE EUROPEAN UNION Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DLEG 51 CODEC 893 LEGISLATIVE ACTS AND OTHER INSTRUMTS Subject: Common Position with
More informationAnnex to a news release
Annex to ECHA News 1 (5) 15 June 2018 Annex to a news release Helsinki, 15 June 2018 SEAC adopted one restriction proposal Lead and its compounds in shot SEAC adopted its final opinion, in support of the
More informationJaneen A. Skutnik-Wilkinson ICH Topic co-creator EWG Team Member
Janeen A. Skutnik-Wilkinson ICH Topic co-creator EWG Team Member April 2012 1 Metal Impurities (aka Heavy Metals) STUCK for at least 10 years No Harmonised guidance in ICH or other regions Establish appropriate
More informationIntroduction to HACCP for the Agri Feed/ Food Supply chain
April 2016 Contents 1 What is HACCP?... 2 1.1 HACCP History... 2 1.2 HACCP in the Agri Feed/ Food Supply Chain today... 2 1.3 HACCP Principles... 3 1.4 The Steps in the HACCP Process... 4 2 How HACCP can
More informationEUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL. PHARMACEUTICAL COMMITTEE 21 October 2015
EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Health systems and products Medicinal products authorisations, European Medicines Agency PHARM 689 PHARMACEUTICAL COMMITTEE 21 October 2015
More informationWorking Document prepared by the Commission services - does not prejudice the Commission's final decision 3/2/2014 COMMISSION STAFF WORKING DOCUMENT
COMMISSION STAFF WORKING DOCUMENT on certain requirements for FSMPs [Supporting Document for the Expert Group meeting of 7 February 2014] Introduction Following the discussions in the Expert Group meeting
More informationWorking together on Food Safety
Working together on Food Safety Bernhard Url Executive Director, EFSA Meeting with representatives of Luxembourg's food safety authorities and art.36 organisations 7 December 2015, Dudelange EFSA S STRATEGY
More informationSUMMARY REPORT OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD IN BRUSSELS ON 10 DECEMBER 2012 (Section General Food Law)
EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL Brussels, SANCO E 1718316 SUMMARY REPORT OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD IN BRUSSELS ON 10 DECEMBER 2012 (Section
More informationHand disinfection PT 1 harmonisation of exposure determinants for professional users
1 (7) Recommendation no. 1 of the BPC Ad hoc Working Group on Human Exposure Hand disinfection PT 1 harmonisation of exposure determinants for professional users (Agreed at the Human Health Working Group
More informationCurrent state of play on FCMs, including the risk assessment Eric Barthélémy, EFSA FCM team
Current state of play on FCMs, including the risk assessment Eric Barthélémy, EFSA FCM team EFSA safety assessment of FCM Based on guidance for submission of an application (dossier) for safety assessment
More informationIPEC Europe Suggested Alternative (if none then original text is clear and needs no alteration) Purpose and Scope
IPEC Europe Observations and Recommendations on Guidelines On The Formalised Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients Of Medicinal Products For Human
More informationECHA Committee for Risk Assessment: Evaluation of the Classification and Labelling of Glyphosate
ECHA Committee for Risk Assessment: Evaluation of the Classification and Labelling of Glyphosate Tim Bowmer, Committee Chairman Ari Karjalainen, Dossier Manager for Glyphosate 10 May 2017 1 Established
More information