(EFSA-Q ) 1 For the purpose of this document foods of animal origin are limited to fresh unprocessed products of animal origin.
|
|
- Constance Hunt
- 6 years ago
- Views:
Transcription
1 Joint AFC/BIOHAZ draft guidance document on the submission of data for the evaluation of the safety and the efficacy of substances other than potable water intended to be used to decontaminate the surface of foods 1 of animal origin (EFSA-Q ) 11 1 For the purpose of this document foods of animal origin are limited to fresh unprocessed products of animal origin. Page 1 of 8
2 TABLE OF CONTENTS BACKGROUND...3 TERMS OF REFERENCE INTRODUCTION TECHNICAL DATA IDENTITY OF THE SUBSTANCE(S) AND SPECIFICATIONS MANUFACTURING PROCESS METHODS OF ANALYSIS OF THE TREATED FOODS OF ANIMAL ORIGIN REACTIONS AND FATE IN THE TREATED FOODS OF ANIMAL ORIGIN THE PROCESS AND ITS PURPOSE EXPOSURE ASSESSMENT TOXICOLOGICAL DATA INFORMATION NEEDED TO JUDGE THE EFFICACY OF DECONTAMINATING PROCESS PROOF OF THE EFFICACY OF THE PROCESS OTHER ISSUES...8 REFERENCES Page 2 of 8
3 BACKGROUND Substances or processes used for the decontamination treatment - other than antibiotics - of foods of animal origin are intended as processing aids to reduce levels of pathogenic microorganisms. For many years, European legislation limited the use of antimicrobial treatment, highlighting the significance and application of good manufacturing practices and/or other safety management systems (e.g. HACCP) in the whole production line. Article 3(2) of Regulation 853/2004 of the European Parliament and Council lays down specific hygiene rules for food of animal origin, effective from 1 January 2006 and provides a legal basis for the use of substances other than potable water to remove surface contamination from foods of animal origin. Moreover, with the adoption of the new Regulations on hygiene 2 and the introduction of the HACCP principles in the entire food chain, establishments will be obliged to improve their hygiene and processing procedures including verification and validation of the used systems. Previous opinions of the Scientific Committee on Veterinary Measures relating to Public Health (SCVPH, 2003 and 1998) concluded that the antimicrobial treatments should be considered as supplementary means of reducing the microbial load of foods of animal origin and should be a part of an integrated control programme throughout the whole food chain. Both opinions stressed that the authorization of antimicrobial substances for antimicrobial treatments should be based on risk assessment, e.g. assessing both the efficacy and the safety. TERMS OF REFERENCE Provide guidance to assist in the evaluation of the safety and efficacy of substances to be used to decontaminate the surface of foods 3 of animal origin intended for human consumption Regulation 852/2004: OJ L226/ , p3; Regulation 853/2004: OJ L226/ , p22 3 For the purpose of this document foods of animal origin are limited to fresh unprocessed products of animal origin Page 3 of 8
4 INTRODUCTION This document is intended as guidance to assist the evaluation of the safety and the efficacy of substances intended to be used to decontaminate the surface of foods of animal origin. Article 3(2) of Regulation 853/2004 of the European Parliament and Council, which lays down specific hygiene rules for food of animal origin, constitutes the legal basis for the use of substances other than potable water to remove surface contamination from foods of animal origin intended for human consumption. The Regulation became effective on 1 January The use of the substances to decontaminate the surface of foods of animal origin is authorised according to the legislative procedures of the European Commission (EC). However, the Commission shall consult EFSA on any matter within the scope of Regulation 853/2004 that could have a significant impact on public health. The EC informed EFSA that decontamination of foods of animal origin intended for human consumption should principally be used to reduce the numbers and/or prevalence of pathogenic microorganisms and be regarded as a processing aid which will be rinsed off after the application. Furthermore, it is a risk management policy that decontamination should be used only as an additional measure to further reduce the load of pathogenic microorganisms after following good hygienic/manufacturing practices and not as a substitute for those good hygienic practices. From a risk management point of view, the use of substances other than potable water can only be accepted if the toxicological safety and efficacy of that treatment can be demonstrated. The evaluation of the safety and the efficacy of such treatments fall within the remit of EFSA. Other relevant considerations, as mentioned in the SCVPH report (1998), which include the impact of the treatment on product quality, on worker safety, on the environment and consumer acceptance must be dealt with by other fora. All the items below must be addressed for the dossier to be considered valid for the evaluation process. If the petitioner submits data other than that required or considers a topic irrelevant in the case(s) of the substance(s) in question, this must be clearly justified for each of those topics. This guidance document will be revised in the light of any new legislation and the experience that EFSA develops handling applications. Page 4 of 8
5 TECHNICAL DATA 2.1. Identity of the substance(s) and specifications Substances, either single or in a simple or complex mixture, must be clearly identified giving respective chemical names (IUPAC), CAS registry numbers, synonyms and trade names, molecular weight, molecular and structural formula, purity, impurities present and their level and description of physical state of the product as marketed Manufacturing process Method of manufacture with description of the source (raw materials), the process used to produce the antimicrobial substance(s), production controls and quality assurance Methods of analysis of the treated foods of animal origin A detailed description of methods of analysis for an adequate detection and quantification of antimicrobial substances, its degradation products and any major reaction products in the foods of animal origin should be provided Reactions and fate in the treated foods of animal origin i. Residual levels in the treated food ii. iii. Description and quantification of any reaction or degradation by-product that may remain in the treated food. Determination of products resulting from potential reactions with natural compounds in the food during and after treatment, especially proteins, peptides, free amino acids and lipid compounds The process and its purpose i. A statement of the purpose of the treatment including a list of the type of foods of animal origin to be treated and the microorganisms the decontaminating treatment is intended to target ii. iii. A list of the pathogenic microorganisms occurring on the surface of foods of animal origin to be treated, and the possible human risks. A description of how the substance(s) will be applied to the surfaces of foods of animal origin, the mode of application, any recycling of the decontaminating substance and description of where in the processing lines the treatment will be applied. This includes the intended doses to be used, ways of Page 5 of 8
6 iv. application (i.e. - rinsing, spraying, etc.), conditions of use (i.e. - temperature, ph, etc.) and duration of treatment. A quantification of the expected residues, by-products and any relevant reaction products to be found in the treated food Exposure assessment An estimate of potential daily exposure to residues, by-products and any relevant reaction products must be provided in the dossier. 3. TOXICOLOGICAL DATA Available toxicological data on each antimicrobial substance, including its potential degradation products and any identified reaction products and degradation and reaction products should be submitted. Depending on these data and on the chemical structure of the substances and the levels remaining in the foods of animal origin, further toxicological data might be requested by EFSA. See e.g. the guidance document on submissions for food additives evaluations ( In cases where a substance is already approved for direct addition to food in the EU, a reference to the exact legislation may suffice in first instance. 4. INFORMATION NEEDED TO JUDGE THE EFFICACY OF DECONTAMINATING PROCESS The proposal should be a coherent presentation of the arguments for use of the decontaminating substance(s) supported by studies of the efficacy of pathogen reduction performed according to the guidelines below and presented in a structured way. It is suggested that each of the items below is addressed briefly in a summary cross-referenced to appropriate enclosures or annexes. 4.1 Proof of the efficacy of the process i. All in-plant studies intended to demonstrate efficacy should be made with the decontaminating product formulation for which authorisation is sought. ii. A comparison of surfaces of food of animal origin treated with the decontaminating agent and a corresponding untreated control food, where the only difference is the decontaminating agent and not the method of application or other factors e.g. if the decontaminating agent is used as a spray or dip, the control food must be sprayed or dipped under identical conditions iii. Tests on sufficient number of samples depending on the actual numbers and/or prevalence of the target organisms. Page 6 of 8
7 iv. The study design must be justified in relation to the specific claim(s) made for the substance and must include a consideration of statistical sound methodology and the capacity to measure expected changes with a probability of P v. The prevalence and/or the number of the target microorganisms must be measured before treatment, after treatment and at the end of the shelf life of the raw food to ensure that there is no repair of sublethally injured organisms. The same testing should also be followed for the control foods. In addition, indicator microorganisms and total viable counts could be measured vi. vii. viii. ix. Despite the antimicrobial treatment being intended to reduce the prevalence and/or numbers of pathogenic microorganisms, experimental data on the behaviour of non-pathogenic microorganisms such as indicator microorganisms and total viable counts, may assist judging the overall efficacy of the proposed treatment. The processing conditions in the study must be comparable with those where the decontaminating agent is intended to be used, e.g. in processing plant or a pilot plant. As far as possible the efficacy of the decontaminating agent should be tested on naturally contaminated foods. Particular attention should be paid to the sensitivity and specificity of the microbiological methods employed and to the adequacy and appropriateness of controls x. Experimental confirmation of the procedure to neutralise or eliminate the residual activity of the substance(s) to prevent interference with enumeration or detection of the target microorganism(s) xi. xii. xiii. xiv. Tests may be used with pathogenic bacteria to evaluate the efficacy, and should take account of strain diversity by testing at least 5-10 different strains, for example strains isolated from human cases and from the particular food. It is recommended to be able to differentiate between strains. Experimental demonstration that the concentration of the decontaminating agent proposed is justified, for instance laboratory data showing the effect of different concentrations of the antimicrobials on the target microorganism(s). A description of the methods to control and monitor the concentration of the active substance(s) in the processing plant along operational time, including identifying factors that may influence the efficacy of the active substances (e.g. ph, temperature etc). If the decontamination treatment effectively reduces numbers / prevalence of a pathogen and also extends the shelf-life, the impact of that extended shelf-life on survival and possible growth of other pathogens should be considered, e.g. Listeria monocytogenes and Yersinia enterocolytica on decontaminated pork. Page 7 of 8
8 Other issues i. Only studies that directly support the purpose of the application will be considered ii. iii. iv. The dossier should include reports of all experiments done including the raw data from those experimental studies. The data and supporting documentation should be of the quality expected of data submitted to a peer-review journal. Any statistical analysis of data should explain the method applied and the statistical power v. Because of the fact that microorganisms naturally resistant to the decontamination treatment may occur, and others might develop resistance to the decontamination treatment, it is recommended, as a control measure, to perform tests of the efficacy of the treatment at intervals. REFERENCES SCVPH (2003) Opinion on the evaluation of antimicrobial treatments for poultry carcasses. SCVPH (1998) Report on the benefits and limitations of antimicrobial treatments for poultry carcasses. Page 8 of 8
Opinion from the Scientific Panel on Biological Hazards on the evaluation of the efficacy of L (+) Lactic acid for carcass decontamination 1
Opinion from the Scientific Panel on Biological Hazards on the evaluation of the efficacy of L (+) Lactic acid for carcass decontamination 1 (EFSA-Q-2005-107A) Adopted on 15-16 March 2006 SUMMARY The European
More informationCOMMISSION IMPLEMENTING REGULATION (EU) /... of XXX
EUROPEAN COMMISSION Brussels, XXX SANTE/10440/2017 Rev. 2 [ ](2017) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX renewing the approval of the active substance glyphosate in accordance
More informationEU Regulation on Microbiological Criteria for Foodstuffs. Mary Howell Hygiene and Microbiology UK Food Standards Agency
EU Regulation on Microbiological Criteria for Foodstuffs Mary Howell Hygiene and Microbiology UK Food Standards Agency import production processing distribution preparation consumption Importers Agro-chemical
More informationEvaluation of the safety and efficacy of Listex TM P100 for reduction of pathogens on different ready-to-eat (RTE) food products
SCIENTIFIC OPINION ADOPTED: 7 July 2016 doi: 10.2903/j.efsa.2016.4565 Evaluation of the safety and efficacy of Listex TM P100 for reduction of pathogens on different ready-to-eat (RTE) food products Abstract
More informationGuideline on requirements for the production and control of immunological veterinary medicinal products
14 June 2012 EMA/CVMP/IWP/206555/2010 Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on requirements for the production and control of immunological veterinary Draft agreed by Immunologicals
More informationEuropean Medicines Agency Evaluation of Medicines for Human Use
European Medicines Agency Evaluation of Medicines for Human Use London, 22 February 2006 EMEA/CHMP/BWP/49348/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL
More informationGuidance on the application of mutual recognition in Norway
Guidance on the application of mutual recognition in Norway Under regulation (EC) No. 1107/2009 Norwegian Food Safety Authority Region Office, Greater Oslo Region Official in charge: Tor Erik Jørgensen
More informationGUIDANCE FOR INDUSTRY ON FIXED DOSE COMBINATIONS (FDCs)
GUIDANCE FOR INDUSTRY ON FIXED DOSE COMBINATIONS (FDCs) DRAFT GUIDANCE This guidance document is for feedback purposes only Comments and suggestions regarding this draft document should be submitted within
More information(Non-legislative acts) REGULATIONS
26.2.2011 Official Journal of the European Union L 54/1 II (Non-legislative acts) REGULATIONS COMMISSION REGULATION (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the
More informationHandbook of Microbiological Quality Control
Handbook of Microbiological Quality Control Pharmaceuticals and Medical Devices Edited by ROSAMUND M. BAIRD Department of Pharmacy and Pharmacology, University of Bath, UK NORMAN A. HODGES School of Pharmacy
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 22 February 2006 EMEA/CHMP/BMWP/42832/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON SIMILAR
More informationNote for Guidance for Food Contact Materials. European Food Safety Authority FOOD CONTACT MATERIALS NOTE FOR GUIDANCE
European Food Safety Authority FOOD CONTACT MATERIALS NOTE FOR GUIDANCE ("NOTE FOR GUIDANCE FOR PETITIONERS PRESENTING AN APPLICATION FOR THE SAFETY ASSESSMENT OF A SUBSTANCE TO BE USED IN FOOD CONTACT
More informationSOUTH BALTIC PROJECT CHECKLIST. Protocol no: Inspection
"Food Hygiene and Food Safety in the Baltic region" Project co-financed by the European Regional Development Fund in the framework of the Programme of the South Baltic Cross-border Co-operation 007-0 SOUTH
More informationAGREEMENT OF THE MEMBER STATE COMMITTEE ON THE IDENTIFICATION OF PENTADECAFLUOROOCTANOIC ACID (PFOA) AS A SUBSTANCE OF VERY HIGH CONCERN
AGREEMENT OF THE MEMBER STATE COMMITTEE ON THE IDENTIFICATION OF PENTADECAFLUOROOCTANOIC ACID (PFOA) AS A SUBSTANCE OF VERY HIGH CONCERN According to Articles 57 and 59 of Regulation (EC) 1907/2006 1 Adopted
More informationAnnex A2. Guidance on Process Validation Scheme for Aseptically Processed Products
Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products 1 Table of content 1 PURPOSE... 3 2 SCOPE... 3 3 GENERAL INFORMATION... 3 4 INFORMATION NEEDED FOR ASEPTIC PROCESSES VALIDATION...
More information(Acts whose publication is obligatory) DIRECTIVE 98/8/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. of 16 February 1998
EN Official Journal of the European Communities L 123/1 I (Acts whose publication is obligatory) DIRECTIVE 98/8/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 February 1998 concerning the placing
More informationMicrobiological criteria and shelf-life. ...Current legal situation
Microbiological criteria and shelf-life...current legal situation Dr. Mary Friel Technical Executive, FSAI Commission Regulation (EC) No 2073/2005 on Microbiological Criteria for Foodstuffs Entered into
More informationEU Food Law. protect public health (human, animal and plant);
EU Food Law The frame for the EC food safety legislation was given by the Article 3 of the Rome Treaty (1957) to assure the free movement of products within the common market. Based on that, the general
More informationSetting Specifications for Biotech Products
Setting Specifications for Biotech Products Session 1: What to Control? Presentation by an EU Regulator Nanna Aaby Kruse, Senior Biological Assessor, member of BWP and BMWP WHAT TO CONTROL? Control of
More informationBiocidal Products Committee (BPC)
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance: Bacillus amyloliquefaciens strain ISB06 Product type: 3 ECHA/BPC/085/2015 Adopted 10 December 2015 Annankatu
More informationCOUNCIL OF THE EUROPEAN UNION. Brussels, 30 November /05. Interinstitutional Files: 2003/0256 (COD) 2003/0257 (COD) LIMITE
COUNCIL OF THE EUROPEAN UNION Brussels, 30 November 2005 Interinstitutional Files: 2003/0256 (COD) 2003/0257 (COD) 15155/05 LIMITE COMPET 275 ENV 573 CHIMIE 70 CODEC 1121 NOTE from : General Secretariat
More informationUnderstanding the requirements of EU food contact legislation
Understanding the requirements of EU food contact legislation Dr. Annette Schäfer Head of Sector Food Contact Materials DG SANCO The content of this lecture does not necessarily represent the position
More informationDelegations will find enclosed the draft text of the REACH Regulation as agreed by the Competitiveness Council at its meeting on 13 December 2005.
COUNCIL OF THE EUROPEAN UNION Brussels, 19 December 2005 Interinstitutional File: 2003/0256 (COD) 2003/0257 (COD) 15921/05 COMPET 289 ENV 606 CHIMIE 74 CODEC 1198 NOTE from : General Secretariat to : Delegations
More informationA GUIDELINE ON DOSSIER REQUIREMENTS FOR TYPE I VARIATIONS November 1999
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Pharmaceuticals and cosmetics Final Revision 0 NOTICE TO APPLICANTS A GUIDELINE ON DOSSIER REQUIREMENTS FOR TYPE I VARIATIONS November 1999 This guideline
More informationGENERAL AND ORGANISATIONAL REQUIREMENTS
NBOG working document applicable for MDR and IVDR WD 2017-1 Draft list of documents to be submitted in the application for designation as a notified body under Regulation (EU) 2017/745 and Regulation (EU)
More informationTechnical Notes for Guidance on. Dossier Preparation including preparation and evaluation of study summaries
Technical Notes for Guidance on Dossier Preparation including preparation and evaluation of study summaries under Directive 98/8/EC Concerning the Placing of Biocidal Products on the Market 28 March 2002
More informationAUDIT REPORT. Audit of Offi cial Controls carried out by the Local Authority Veterinary Service Leitrim County Council
AUDIT REPORT Audit of Offi cial Controls carried out by the Local Authority Veterinary Service AUDIT REPORT Audit of Official Controls carried out by the Local Authority Veterinary Service TABLE OF CONTENTS
More informationCOUNCIL DIRECTIVE of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (OJ L 230, , p.
1991L0414 EN 01.02.2007 016.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B COUNCIL DIRECTIVE of 15 July 1991 concerning
More informationScientific Opinion on Composting and incineration of dead-on-farm pigs 1
EFSA Journal 2012;10(2):2559 SCIENTIFIC OPINION Scientific Opinion on Composting and incineration of dead-on-farm pigs 1 ABSTRACT EFSA Panel on Biological Hazards (BIOHAZ) 2, 3 European Food Safety Authority
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 22 February 2006 EMEA/CHMP/BMWP/94528/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) ANNEX TO GUIDELINE
More informationAntimicrobial packaging films with a sorbic acid based coating
Available online at www.sciencedirect.com Procedia Food Science 1 (2011) 197 202 11 th International Congress on Engineering and Food (ICEF11) Antimicrobial packaging films with a sorbic acid based coating
More informationStatement on technical assistance on the format for applications for new alternative methods for animal by-products 1
SCIENTIFIC OPINION Statement on technical assistance on the format for applications for new alternative methods for animal by-products 1 EFSA Panel on Biological Hazards (BIOHAZ) 2, 3 European Food Safety
More informationDried meat Specification
DRAFT KENYA STANDARD DKS 2723: 2016 ICS 67.120 Dried meat Specification PUBLIC REVIEW DRAFT, MARCH 2017 No copying of this standard without KEBS permission except as permitted by copyright law KEBS 2016
More informationGUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
MDEG - 2007-12 - II-3.3 MSOGClassIGuidance_Final GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES Foreword These guidance notes do not aim to be a definite interpretation of National Laws and/or
More informationEUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 25 October 2005 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU
More informationMEDICATED FEEDINGSTUFFS AND SPECIFIED FEED ADDITIVES REGULATION AND APPROVAL OF MANUFACTURERS
MEDICATED FEEDINGSTUFFS AND SPECIFIED FEED ADDITIVES REGULATION AND APPROVAL OF MANUFACTURERS JANIS MCDONALD Medicated Feedingstuffs and Specified Feed Additives Operations Manager VETERINARY MEDICINES
More informationTable of Contents Page
COMPLIANCE GUIDELINES TO CONTROL LISTERIA MONOCYTOGENES IN POST-LETHALITY EXPOSED READY-TO-EAT MEAT AND POULTRY PRODUCTS Summary of Guidance Material Table of Contents Page 3 A. Introduction 4 B. Control
More informationIMPLEMENTING ACT TO THE POLICY ON DECLARATION OF INTERESTS PROCEDURE FOR IDENTIFYING AND HANDLING POTENTIAL CONFLICTS OF INTEREST
IMPLEMENTING ACT TO THE POLICY ON DECLARATION OF INTERESTS PROCEDURE FOR IDENTIFYING AND HANDLING POTENTIAL CONFLICTS OF INTEREST INTRODUCTION 1. Article 37 of Regulation (EC) No 178/2002 laying down the
More informationThe New EU IVDR. Overview of the Main Changes & Clinical Data Requirements. Advance Regulatory Consulting Ltd.
Overview of the Main Changes & Clinical Data Requirements Advance Regulatory Consulting Ltd. : Timeline: Entry in to force Q2 (Apr) 2017 Adoption: +6m NB s apply for designation IVDs classified as Class
More informationNanomaterials in REACH
EUROPEAN COMMISSION ENVIRONMENT DIRECTORATE-GENERAL Water, Chemicals & Cohesion Chemicals ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Chemicals, Metals, Forest-based & Textile Industries REACH Brussels,
More informationAdoption by CHMP for release for 3-month public consultation 18 November End of consultation (deadline for comments) 28 February 2011
18 October 2012 EMA/651649/2010 Committee for Medicinal Products for Human Use Reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer), a complex, a derivative,
More informationThe rules governing medicinal products in the European Union. Presentation and content of the dossier Edition
The rules governing medicinal products in the European Union Volume 2B Notice to Applicants Medicinal products for human use Presentation and content of the dossier 1998 Edition EUROPEAN COMMISSION Directorate
More informationJustification Document for the Selection of a CoRAP Substance - Update -
_ Justification Document for the Selection of a CoRAP Substance - Update - Substance Name (public name): Tetradecahydro-7-isopropyl-1,4adimethylphenanthren-1-methanol EC Number: 236-476-3 CAS Number: 13393-93-6
More informationTransparency and sustainability of the EU risk assessment process
Transparency and sustainability of the EU risk assessment process 6 March 2018 EuropaBio position Strengthening of trust requires a holistic approach - Transparency and sustainability of the EU risk assessment,
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2012R0528 EN 25.04.2014 002.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT
More informationREGULATIONS. L 44/2 Official Journal of the European Union
L 44/2 Official Journal of the European Union 18.2.2011 REGULATIONS COMMISSION REGULATION (EU) No 143/2011 of 17 February 2011 amending Annex XIV to 1907/2006 of the European Parliament and of the Council
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2003R1830 EN 11.12.2008 001.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B REGULATION (EC) No 1830/2003 OF THE EUROPEAN
More informationEuropean Legislation in Relation to Food Safety in Production of Poultry Meat and Eggs
2007 Poultry Science Association, Inc. European Legislation in Relation to Food Safety in Production of Poultry Meat and Eggs R. W. A. W. Mulder* 1 and H. Hupkes *Spelderholt Poultry Consulting and Research,
More informationImport tolerances in the European Union Can Import Tolerances be set for active substances impacted by the EU hazard-based criteria?
Import tolerances in the European Union Can Import Tolerances be set for active substances impacted by the EU hazard-based criteria? May 2017 Abstract The aim of this paper is to provide information on
More informationWorkshop Efficacy Requirements and Evaluation of Plant Protection Products based on Low-Risk Active Substances, Ede (NL), /07
Workshop Efficacy Requirements and Evaluation of Plant Protection Products based on Low-Risk Active Substances, Ede (NL), 2016-04-06/07 CONCLUSIONS and RECOMMENDATIONS On 6 th and 7 th of April 2016, more
More informationPLANNING FOR REACH 2018 AS A NON-EU COMPANY
PLANNING FOR REACH 2018 AS A NON-EU COMPANY Joyce Borkhoff Vice President, Chemicals Group Intertek Scientific & Regulatory Consultancy AGENDA 01 02 Overview of REACH Requirements Specific to Non-EU Companies
More informationAgenzia Italiana del Farmaco
Agenzia Italiana del Farmaco European Regulation on Advanced Therapies Cristina Pintus Head of European Relations Unit and Coordinator of the Advanced Therapy Project Italian Medicines Agency Proposal
More informationReflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances
3 July 2017 EMA/CHMP/CVMP/QWP/826771/2016 Corr. 1 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Reflection paper on the requirements for
More informationMICROBIOLOGICAL CULTURE MEDIA
MICROBIOLOGICAL CULTURE MEDIA A COMPLETE GUIDE FOR PHARMACEUTICAL AND HEALTHCARE MANUFACTURERS Tim Sandle Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers
More informationWHO GUIDELINE Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
WHO GUIDELINE Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 1. Introduction 1.1 Objectives of these guidelines 1.2 Scope of these guidelines 1.3 General principles
More informationCurrent challenges from Evaluation point of view - Introduction case studies
Current challenges from Evaluation point of view - Introduction case studies Expert Workshop Dealing with Uncertainty of Non-Test Methods under REACH 23-24 September 2010 Wim De Coen ECHA Evaluation I
More informationI EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Ref. Ares(2014)2013769-19/06/2014 I EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) 2013-7244 FINAL MICROBIOLOGICAL CRITERIA FOR FOOD OVERVIEW
More informationGuideline on setting specifications for related impurities in antibiotics
1 2 3 4 14 July 2010 EMA/CHMP/CVMP/QWP/199250/2009 Committee for Medicinal Products for Human Use (CHMP) / Committee for Medicinal Products for Veterinary Use (CVMP) 5 6 7 Guideline on setting specifications
More informationEUROPEAN COMMISSION. GUIDANCE DOCUMENT Implementation of certain provisions of Regulation (EC) No 852/2004 on the hygiene of foodstuffs
EUROPEAN COMMISSION GUIDANCE DOCUMENT Implementation of certain provisions of Regulation (EC) No 852/2004 on the hygiene of foodstuffs EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL
More informationL 96/26 EN Official Journal of the European Union. REGULATION (EC) No 552/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL.
L 96/26 EN Official Journal of the European Union REGULATION (EC) No 552/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 10 March 2004 on the interoperability of the European Air Traffic Management
More informationEnvironmental Protection Agency-EPA. EPA Registration
Environmental Protection Agency-EPA EPA Registration Biochemical Product Chemistry http://www.epa.gov/fedrgstr/epa-pest/2007/october/day-26/p20828.htm htm Biological Pesticides (40 CFR 180.65) Unique modes
More informationPharmabiotics: a Regulatory Hurdle in Europe
Pharmabiotics: a Regulatory Hurdle in Europe Dr. Magali Cordaillat-Simmons PRI Executive Scientist Raleigh, NC, USA September 8th, 2014 PHARMABIOTICS: A REGULATORY HURDLE IN EUROPE I. Introduction to Pharmabiotics
More informationChapter 2 Validation of Control Measures 1
Chapter 2 Validation of Control Measures 1 2.1 Introduction ICMSF previously discussed validation of control measures in the supply chain (Zwietering et al. 2010) and portions of that paper are included
More informationGUIDELINES FOR EVALUATION OF PESTICIDE BIO EFFICACY TRIAL REPORTS
GUIDELINES FOR EVALUATION OF PESTICIDE BIO EFFICACY TRIAL REPORTS PREPARED UNDER THE AUSPICES OF THE WEST AFRICA AGRICULTURE PRODUCTIVITY PROGRAMME (WAAPP) FOR USE BY PESTICIDE REGISTRATION EXPERTS ENVIRONMENTAL
More informationPRINCIPLES AND GUIDELINES FOR THE CONDUCT OF MICROBIOLOGICAL RISK ASSESSMENT CAC/GL Adopted Amendments 2012, 2014.
PRINCIPLES AND GUIDELINES FOR THE CONDUCT OF MICROBIOLOGICAL RISK ASSESSMENT CAC/GL 30-1999 Adopted 1999. Amendments 2012, 2014. CAC/GL 30-1999 2 1. INTRODUCTION 2. SCOPE 3. DEFINITIONS 4. GENERAL PRINCIPLES
More informationGuidance on the Biocidal Products Regulation
G U I D A N C E Guidance on the Biocidal Products Regulation Volume II Efficacy Assessment and Evaluation (Parts B & C) DRAFT Version.0 August 0 DRAFT Guidance on the BPR:Volume II Parts B & C PUBLIC Version.0
More informationCONTENTS 1 INTRODUCTION The Regulatory Focus on Quality Risk Management Objectives of Risk Assessment and Risk Management: The Key Concepts Key Terms in Relation to Risk and Risk Assessment Structure of
More informationGood manufacturing practices
The rules governing medicinal products in the European Union Volume 4 Good manufacturing practices Medicinal products for human and veterinary use 1998 Edition EUROPEAN COMMISSION Directorate General III
More informationDRAFT OECD GLP ADVISORY DOCUMENT NO. 19 ON THE MANAGEMENT, CHARACTERISATION AND USE OF TEST ITEMS PREAMBLE
DRAFT OECD GLP ADVISORY DOCUMENT NO. 19 ON THE MANAGEMENT, CHARACTERISATION AND USE OF TEST ITEMS PREAMBLE 1. This guidance provides clarity for test facilities on the expectations of national Good Laboratory
More informationThe best quality assurance for meat and animal feed comes from the Netherlands
The best quality assurance for meat and animal feed comes from the Netherlands The Dutch livestock and meat sectors have a worldwide reputation to uphold as reliable suppliers of quality produce. To safeguard
More informationDraft regional guidelines on stability testing of active substances and pharmaceutical products
Regional Committee for the EM/RC53/12 Eastern Mediterranean August 2006 Fifty-third Session Original: Arabic Agenda item 17 Draft regional guidelines on stability testing of active substances and pharmaceutical
More informationRecommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation
2 March 2010 EMA/COMP/15893/2009 Final Committee for Orphan Medicinal Products (COMP) Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for
More informationMicrobiological Consideration for Non-Sterile Pharmaceutical
May 1-3, 2012 Javits Center New York, NY Microbiological Consideration for Non-Sterile Pharmaceutical Dr. Leonard W. Mestrandrea Principal Consultant MESTRANDREA CONSULTING LLC Title Date Microbial Control
More informationVLOG Ohne Gentechnik Production and Certification Standard Revision Information
VLOG Ohne Gentechnik Production and Certification Standard Revision Information Below, you will find a list of all the significant revisions made to the VLOG "Ohne Gentechnik" Production and Certification
More informationFINAL DOCUMENT. International Medical Device Regulators Forum. Medical Device Regulatory Audit Reports
FINAL DOCUMENT International Medical Device Regulators Forum Title: Authoring Group: Medical Device Regulatory Audit Reports IMDRF MDSAP Working Group Date: 2 October 2015 Toshiyoshi Tominaga, IMDRF Chair
More informationLEGAL REQUIREMENTS FOR STABILITY
BY DR. A.V.PRABHU LEGAL REQUIREMENTS FOR STABILITY 21 CFR 211.166- STABILITY TESTING GMP To assess stability characteristics to determine storage conditions and expiration dates. Written stability program
More informationEVALUATION OF THE HYGIENE STATUS IN SEVERAL MEAT AND DAIRY PROCESSING ESTABLISHMENTS IN R.MACEDONIA
Available online at www.macvetrev.mk Mac Vet Rev ; 6 (): 5 Original Scientific Article UDC: 579.64:67.5(497.7) EVALUATION OF THE HYGIENE STATUS IN SEVERAL MEAT AND DAIRY PROCESSING ESTABLISHMENTS IN R.MACEDONIA
More informationProposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
EUROPEAN COMMISSION Brussels, 22.4.2015 COM(2015) 177 final 2015/0093 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 1829/2003 as regards the
More informationDIRECTIVE 2009/41/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
21.5.2009 Official Journal of the European Union L 125/75 DIRECTIVES DIRECTIVE 2009/41/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 on the contained use of genetically modified micro-organisms
More informationGuidelines for Observers for open plenary meetings
Parma, 20 February 2017 Guidelines for Observers for open plenary meetings Pursuant to Article 28(9)(f) of Regulation (EC) No 178/2002 1, the European Food Safety Authority (EFSA) may invite observers
More informationCODE OF HYGIENIC PRACTICE FOR MILK AND MILK PRODUCTS
CODE OF HYGIENIC PRACTICE FOR MILK AND MILK PRODUCTS CAC/RCP 57-2004 INTRODUCTION 1 1. OBJECTIVES 1 2. SCOPE AND USE OF THE DOCUMENT 1 2.1 Scope 1 2.2 Use of the document 1 2.3 Overarching principles applying
More informationECHA 1(7) Helsinki, 19 May 2014
1(7) Helsinki, 19 May 2014 Decision/annotation number: Please refer to the REACH-IT message which delivered this communication ( in format SEV-D-XXXXXXXXXX-XX-XX/F) DECISION ON SUBSTANCE EVALUATION PURSUANT
More informationInformation, test or study provided Y/P/N #
- A11/20 - Part 4 Evaluation Form 4 - for use in checking that all test and study reports required in accordance with Annex IIIP have been Preparation: Active substance(s): PHEROMONE Applicant: Date: APRIL
More informationREACH REGULATION: the new management of chemicals in Europe and operational tools. R egistration. E valuation. A Ch. uthorisation.
REACH REGULATION: the new management of chemicals in Europe and operational tools R egistration E valuation A Ch uthorisation emicals Index of topics Set of rules before REACH Regulation REACH REGULATION
More informationSpotlight on Animal Health Business Operations: A Legal Update Husch Blackwell LLP. March 5, 2015
Spotlight on Animal Health Business Operations: A Legal Update Husch Blackwell LLP March 5, 2015 Environmental Compliance, Planning and Management Systems I. Introduction A. Manufacturers and distributors,
More informationInterpretation of Microbiological Test Results. Nicola Elviss FW&E Microbiology Network June 2010
Interpretation of Microbiological Test Results Nicola Elviss FW&E Microbiology Network June 2010 PHLS Guidelines for the microbiological quality of some ready-to-eat foods at the point of sale: 1992, revised
More informationModule C Veterinary Public Health Hygienic Production of Food (C VPH.2)
Hygienic Production of Food (C VPH.2) Module Leader - Dr Silvia Alonso Alvarez DVM MScEpi PhD Lecturer in LEARNING OBJECTIVES 1. Legislative Objective: Prevention and control of food-borne hazards relating
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES. Draft. COMMISSION REGULATION (EU) No /
EN EN EN COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, C Draft COMMISSION REGULATION (EU) No / of [ ] amending Commission Regulation (EC) No 1702/2003 laying down implementing rules for the airworthiness
More information1. Checklist for Grant of permission to manufacture/import of Bulk Drug already approved in the country
1. Checklist for Grant of permission to manufacture/import of Bulk Drug already approved in the country S no 1. Name of Applicant with address 2. Name of Drug 3. Therapeutic Class 4. Date of Approval Documents
More informationExplanatory Memorandum: The Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) (Amendment) Regulations 2010
Explanatory Memorandum: The Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) (Amendment) Regulations 2010 This Explanatory Memorandum has been prepared by the Food Standards Agency
More informationRisk Management Option Analysis Conclusion Document
Risk Management Option Analysis Conclusion Document Substance Name: Nickel sulphide and trinickel disulphide EC Number: 240-841-2 and 234-829-6 CAS Number: 16812-54-7 and 12035-72-2 Authority: German and
More informationREGULATORY CONTROL OF SAFETY AT NUCLEAR FACILITIES
REGULATORY CONTROL OF SAFETY AT NUCLEAR FACILITIES 1 GENERAL 5 2 GOVERNMENT RESOLUTION 5 2.1 Application and its processing 5 2.2 Documents to be submitted to STUK 6 3 CONSTRUCTION LICENCE 6 3.1 Licence
More informationIFSQN Validation Blog References January 2015
(1) Codex GUIDELINES FOR THE VALIDATION OF FOOD SAFETY CONTROL MEASURES CAC/GL 69-2008 Validation: Obtaining evidence that a control measure or combination of control measures, if properly implemented,
More informationAn introduction to socioeconomic analysis in the REACH authorisation process
An introduction to socioeconomic analysis in the REACH authorisation process Richard Dubourg, Risk Management Implementation Unit, ECHA July 2012 Context and introduction REACH aims to encourage and in
More informationIntroduction to Interventions
Despite the extensive scientific progress and technological developments achieved in recent years, microbial foodborne illness remains a global concern. Specific sources that contribute microbial contamination
More informationDevelopment of non-substantially manipulated cell-based ATMPs 1 : flexibility introduced via the application of the risk-based approach
3 July 2017 EMA/CAT/216556/2017 Inspections, Human Medicines, Pharmacovigilance and Committees Division Development of non-substantially manipulated cell-based ATMPs 1 : flexibility introduced via the
More informationGuideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
14 September 2017 EMA/CHMP/BWP/534898/2008 rev. 1 Committee for Medicinal Products for Human Use (CHMP) Guideline on the requirements for quality documentation concerning biological investigational medicinal
More informationVariation Regulations (EU)
Variation Regulations (EU) Headlines of the Update APIC c view Hilde Vanneste APIC Task Force leader Hilde.Vanneste@its.jnj.com 1 Content Scope of regulation: Type of procedures and hence 2 strands Current
More informationREPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL
EUROPEAN COMMISSION Brussels, 11.5.2012 COM(2012) 212 final REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the application of Council Regulation (EC) No 834/2007 on organic production
More informationThis document is copyright protected.
of Purpureocillium lilacinum (syn. Paecilomyces lilacinus) 251 Page 1 of 8 BioAct WG, 1 X 10 10 spes/gram (60 g/kg) of Purpureocillium lilacinum (syn. Paecilomyces lilacinus) 251 Microbial pest control
More information