Study for the strategy for a non-toxic environment of the...

Written by Joost Bakker (RIVM) August 2017

Study for the strategy for a non-toxic environment of the

7th EAP

Sub-study g: Early Warning Systems for emerging

chemical risks

EUROPEAN COMMISSION

Directorate-General for Environment Directorate B — Circular Economy & Green Growth Unit B.2 — Sustainable Chemicals

European Commission B-1049 Brussels

EUROPEAN COMMISSION

Directorate-General for Environment Sustainable Chemicals

August 2017

Study for the strategy for a non-

toxic environment of the 7th EAP

Sub-study g: Early Warning Systems for emerging chemical

risks

This sub-study report has been prepared by Joost Bakker, Yuri Bruinen de Bruin, Elbert

Hogendoorn, Nicole Palmen and Lya Soeteman-Hernandez of the National Institute for Public

Health and the Environment (RIVM).

The views expressed herein are those of the consultants alone and do not necessarily represent

the official views of the European Commission.

Milieu Ltd (Belgium), Chaussée de Charleroi 112, B-1060 Brussels, tel.: +32 2 506 1000;

e-mail: [email protected]; web address: www.milieu.be.

mailto:[email protected]://www.milieu.be/

Sub-study g: Early warning systems for emerging chemical risks

TABLE OF CONTENTS

ABBREVIATIONS USED .......................................................................................................... 7 ABSTRACT ........................................................................................................................... 10 EXECUTIVE SUMMARY ........................................................................................................ 11 1 INTRODUCTION........................................................................................................... 17 2 OVERVIEW OF THE STATUS QUO ................................................................................ 19

2.1 Definition and scope of an Early warning system .......................................... 19 2.2 General approach of an early warning methodology ................................. 19

2.2.1 Detecting signals .................................................................................. 21 2.2.2 Signal strengthening and priority setting ........................................... 22 2.2.3 Follow-up actions and communication ............................................ 24

3 LITERATURE REVIEW ..................................................................................................... 25 3.1 Early warning systems for environmental protection ..................................... 26 3.2 Early Warning systems for worker health and safety ...................................... 31 3.3 Early warning systems for consumers ............................................................... 39

3.3.1 Food ........................................................................................................ 39 3.3.2 Non-food consumer products ............................................................ 43

4 OVERVIEW OF EARLY WARNING SYSTEMS ................................................................ 49 4.1 Environment ......................................................................................................... 49 4.2 Workers ................................................................................................................. 49 4.3 Consumers non-food and food ........................................................................ 50 4.4 Summary .............................................................................................................. 51

5 POTENTIAL TO SET-UP AN EU-WIDE EWS .................................................................... 54 5.1 What is needed to advance NERCs for the environment? .......................... 54 5.2 What is needed to advance work-related NERCs? ....................................... 55 5.3 What is needed to advance consumer-related NERCs? ............................. 55

6 CONCLUSIONS ........................................................................................................... 57 6.1 General conclusions ........................................................................................... 57 6.2 Improvement Opportunities .............................................................................. 58

REFERENCES ....................................................................................................................... 62 APPENDIX 1. QUESTIONNAIRES FOR LITERATURE REVIEW ................................................. 68 APPENDIX 2. OVERVIEW OF COUNTRIES AND THEIR ORGANIZATIONS ........................... 69 APPENDIX 3. QUESTIONNAIRE ‘EARLY WARNING SYSTEMS’ ............................................. 72 APPENDIX 4. EFSA’S STANDARD TEMPLATE FOR THE DISCUSSION OF EMERGING ISSUES

IN FOOD ............................................................................................................................. 76 APPENDIX 5. GAPS AND DEFICITS IDENTIFIED ................................................................... 78 APPENDIX 6. IDEAS FOR IMPROVEMENT ........................................................................... 80

LIST OF TABLES

Table 1: Overview of potential data sources that can be applied in prioritisation ..... 23

Table 2: Overview of organisations collecting possible NERCs (countries with clinical

watch systems designed to detect NERCs are printed in bold) .................................... 34

Table 3: Evaluation of a first report of a possible NERC .................................................... 36

Table 4: An overview of databases and their managing organisations ....................... 37

Table 5: National contact points for the reporting of (serious) undesirable effects via

EU cosmetovigilance ............................................................................................................. 45

Table 6: An overview of additional useful sources of NERCs for non-food consumer

products .................................................................................................................................. 48

Table 7: Relevant mechanisms identified for specific and general policy areas, where

early warnings of chemical risks are considered particularly important: (i)

environmental protection; (ii) occupational health and safety; and (iii) consumer

protection, including food safety; (iv) general ................................................................. 52

Table 8: Proposal for setting up and organising a European EWS .................................. 60

LIST OF FIGURES

Figure 1: Norman network approach on finding NERCs in water ................................... 27 Figure 2: Schematic of the approach to the tracing of NERCs (Hogendoorn, 2014) .. 28 Figure 3: Proposed algorithm for identifying priorities (SCENIHR, 2009) .......................... 30 Figure 4: Delphi method used by EU-OSHA to identify NERCs (EU-OSHA, 2009) ........... 33 Figure 5: General procedure for the identification of emerging risks (adapted from

EFSA, 2009) .............................................................................................................................. 42 Figure 6: Decision tree for the identification of SUEs in cosmetic products (adapted

from EC, 2012) ........................................................................................................................ 45

ABBREVIATIONS USED

AF

ANSES

Advisory Forum

Agence Nationale de Sécurité Sanitaire

BEUC European Consumer Association, Bureau Européen des Unions de

Consommateurs

Bfr Federal Institute for Risk Assessment

BVL Federal Office on Consumer Protection and Food Safety (Germany)

CAD Chemical Agents Directive

CEI Centres for Epidemiology and Animal Health Centres for Emerging Issues

CEPA Canadian Environmental Protection Act

CEPROSS Communication of Occupational Diseases, Social Security

CESES Consumer Exposure, Skin Effects and Surveillance

CIS Common Implementation Strategy of the Water Framework Directive

CLP Classification, Labelling and Packaging of substances and mixtures

CMR Carcinogenic, Mutagenic or Reprotoxic

COEH Centre for Occupational and Environmental Health

CPSC Consumer Product Safety Commission

CRL Community Reference Laboratory

CSA Chemical Safety Assessment

CSR

CTGB

Chemical Safety Report

Board for the Authorisation of Plant Protection Products and Biocides in the

Netherlands

DMEL Derived-Minimum-Effect-Level

DNEL Derived-No-Effect-Level

EAP Environment Action Programme

EASIS Endocrine Active Substances Information System

EC

ECDC

European Commission

European Centre for Disease Control

ECETOC European Centre for Ecotoxicity and Toxicity of Chemicals

ECHA European CHemicals Agency

ED Endocrine Disruptor

EEA European Environment Agency

EFSA

EMEA

EMM

European Food Safety Authority

European Medicines Agency

European Media Monitor

EMPODAT Emerging Pollutant DATabase

EMRISK Emerging Risks Unit at the EFSA

EPIDERM European Prevention Initiative for Dermatological Malignancies

EQS

EREN

ESCO

EFTA

Environmental Quality Standards

Emerging Risk Exchange Network

EFSA Scientific Cooperation Working Group

European Free Trade Association

EU European Union

EU-OSHA European Agency for Occupational Safety and Health Administration

EU-RAR

EUROSTAT

European Risk Assessment Report

European Union statistical office

EVESCAP Valoración de sospecha de cáncer professional

EWG Environmental Working Group

EWS Early Warning System

EXPOCASTTM

US-EPA research programme: Exposure Science for Prioritisation and Toxicity

Testing

FAO Food Agricultural Organization of the United Nations

GAST

GIEWS

GOARN

GPHIN

Le Groupe d’Alerte en Santé Travail

Global Information and Early Warning System on food and agriculture

Global Outbreak and Alert and Response Network

Global Public Health Intelligence Network system

GPSD General Product Safety Directive

HSE Health Safety Environment

I&M Ministry of Infrastructure and the Environment (the Netherlands)

IGZ Inspectie voor de Gezondheidszorg/Health Care Inspectorate

IIDB Industrial Injuries Disablement Benefit

ILO International Labour Organization

INAIL

INFOSCAN

National Institute for Insurance against Accidents at Work (Italy)

International Food Safety Authorities Network

IPCheM

JRC

Information Platform for Chemical Monitoring

Joined Research Centre

LOQ Limit of Quantification

KWR Watercycle Research Institute

MALPROF Italian system for recording and surveillance of work-related diseases under

INAIL

MEC Measured Environmental Concentration

MODERNET Monitoring trends in Occupational Diseases and tracing new or Emerging Risks

MSDS Material Safety Data Sheet

MTR Maximaal Toelaatbaar Risiconiveau (MPC, Dutch Maximum Permissible

Concentration)

MW Molecular Weight

NCOD Netherlands Centre for Occupational Disease

NERCs New and/or Emerging Risks of Chemicals

NGO Non-Governmental Organisation

NIOSH National Institute for Occupational Safety and Health

NORMAN Network of reference laboratories, research centres and related organisations for

monitoring of emerging environmental substances

NVIC Nationaal Vergiftigingen Informatie Centrum/Dutch National Poisons

Information Centre

NVWA Netherlands Food and Consumer Product Safety Authority

OccWatch Occupational diseases sentinel clinical Watch system project

OECD Organisation for Economic Co-operation and Development

OEL Occupational Exposure Limit

OPRA Occupational Physicians Reporting Activity

OSPAR Oslo and Paris Conventions for the North Atlantic marine environment

PANOTRASTSS Incidence and prevalence of occupational diseases in Spain

PBDEs Poly Brominated Diphenyl Ethers

PBT Persistent, Bioaccumulative and Toxic

PFCs Perfluorinated Chemicals

PNEC Predicted-No-Effect Concentration

QSAR Quantitative Structure-Activity Relationship

RAPEX

RASFF

RAS-BICHAT

Rapid Alert System for dangerous non-food products

Rapid Alert System for Food and Feed

Rapid Alert System for Biological and Chemical Attacks and Threats

REACH Registration, Evaluation, Authorisation and restriction of Chemicals

RIDDOR Reporting of Injuries, Diseases, and Dangerous Occurrences Regulations

RIVM National Institute of Public Health and Environment (the Netherlands)

RNV3P National Occupational Diseases Surveillance and Prevention Network (France)

RWS Rijkswaterstaat

SCCP Scientific Committee on Consumer Products

SCCS Scientific Committee on Consumer Safety

SCENIHR Scientific Committee on Emerging and Newly Identified Health

SCER

Risks

Scientific Committee for Emerging Risks

SCHER

SCHEER

Scientific Committee on Health and Environmental Risks

Scientific Committee on Health, Environmental and Emerging Risks

SCOEL The Scientific Committee on Occupational Exposure Limits

SIGNAAL

StaCG-ER

Signalering Nieuwe Arbeidsgerelateerde Aandoeningen Loket/Signaling New

Occupational Diseases Counter

Stakeholders Consultative Group on Emerging Risks

SVHC Substance of Very High Concern

SWORD Surveillance of Work Related and occupational lung Disease

SZW

SUE

Ministry of Social Affairs and Employment (the Netherlands)

Serious Undesired Event

TERA Toxicology Excellence for Risk Assessment

THOR The Health and Occupation Research

TRA Targeted Risk Assessment

UN United Nations

US-EPA

US-FDA

vPvB

United States Environmental Protection Agency

Food and Drug Administration of the United States

very Persistent and very Bioaccumulative

VWS

WHO

Ministry of Health, Welfare and Sport (the Netherlands)

World Health Organization

WFD Water Framework Directive

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Study for the strategy for a non-toxic environment of the 7th EAP

Sub-study g: Early Warning Systems for emerging chemical risks, August 2017 /10

ABSTRACT

This report describes the current methodologies for finding new and/or emerging risks (NERCs) for

the protection of workers, consumers and the environment. The key goal here is the identification of a

generally applicable methodology to finding NERCs for each of these three protection groups. The

feasibility of such a universal approach must also be addressed, in light of the differences in the

discovery and evaluation of NERC signals.

The systems that exist at present depend highly upon observed and documented signals relating to

occurrence of effects and potential exposure, the so-called “effect based” or “disease first” systems.

Some systems contain elements that can be used to proactively identify possible NERCs, based on a

proper risk assessment, the so-called “exposure first” methods.

The analysis of existing national and international tools and methods, developed and in operation for

the early identification of new or upcoming chemical threats, identified several reasons why existing

approaches are not completely satisfactory and why greater effort at the European Union level is

needed.

The continuous effort of screening and filtering signals is essential to early identification, but a labor-

intensive process needs input from experts, which is not organized and coordinated at an international

level.

An international platform, working continuously on the identification of chemical threats and in the

application of different approaches for collecting these signals appears to be lacking. In general, there

is a need for greater cooperation and exchange of information at the EU level on NERCs. An overall

integral approach covering identification, finding further evidence, and proposing appropriate risk

management measures at the EU level is needed in order to facilitate progress towards a non-toxic

environment, but seems to be missing. However, there are various initiatives in the areas of early

identification, data collection, and the management of chemical threats at the national and

international levels that could possibly connect to the establishment of an early warning system.

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EXECUTIVE SUMMARY

Chemicals regulation in the European Union aims at the safe use of chemicals and protecting man and

the environment through predicting the hazardous properties and by limiting exposure through risk

management measures. Despite the various kinds of legislation, numerous well-documented cases

exist of extensive damage to health and environment caused by the production and use of chemicals.

Furthermore, it often takes a long time for societal institutions to pick up on these warning signals, and

even longer for them to react.

For example, 10 of the 15 Late Lessons from Early Warnings identified by the European Environment

Agency are directly linked to chemicals with hazardous properties (i.e. benzene, asbestos, PCBs,

halocarbons, DES, antimicrobials, MTBE, PFAS, TBT, EDCs). Half of those cases highlighted issues

caused by the persistent nature of chemicals (i.e. PCBs, halocarbons, MTBE, PFAS and TBT), several

emphasized the additional risks induced by the cumulative effect of hazardous substances (i.e. PCBs,

halocarbons, MTBE, TBT, EDCs), and two underlined the impacts of late lessons on vulnerable

groups (i.e. PCBs, EDCs). Furthermore, instances are highlighted in which years or decades spanned

before regulatory intervention.

This illustrates that the early identification of chemical threats to human health and to the environment

is of great importance in taking timely measures to reduce or to eliminate the risk of hazardous

compounds.

The aim of early warning systems is to identify, as early as possible, those chemicals that might

potentially be hazardous and cause adverse effects, as well as to identify those situations in which

exposures to substances could lead to harm to humans or to the environment. Early identification

allows for appropriate actions to protect man and the environment to be undertaken earlier and can be

of great value in achieving a high level of public safety and environmental protection. Early

identification provides more time for further investigation or the implementation of measures to

prevent or control issues of concern. In this way, an early warning system could facilitate progress

towards a non-toxic environment.

Further, a systematic approach for the early identification of chemical threats could contribute to

identifying gaps in existing legislation, as well as in data and knowledge, and could support

enforcement authorities. Developing an earlyresponse system for detecting and tackling approaching

chemical threats to human health and the environment should however be regarded as a

complementary action, a kind of safety net, though and not as an alternative instrument to replace

current legislation.

A variety of tools, methods and activities have been drawn up, developed or initiated for the early

identification of new or upcoming chemical threats for the protection of workers, consumers and the

environment. These tools and methods are commonly known as Early Warning Systems (EWS) or

Rapid Response Systems (RRS).

This study provides an overview of existing national and international tools and methods as well as an

analysis of the systems for the early identification of new or upcoming chemical threats.

Early warning systems considered

Important aspects to consider when establishing an early warning system include the definition of new

and/or emerging risks (NERCs) and the system’s specific aim. This pre-defines what the system will

be able to do and sets the boundaries to the kind of information to use and the output to generate.

A variety of terms and definitions have been used, such as new risk, emerging risk, emerging issue,

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emerging pollutant, emerging substance, and contaminant of emerging concern. These can be grouped

into three main categories: (i) newly created risk; (ii) newly identified risk; or (iii) increasing risk

becoming widely known or established. Examples of the last category includes combined and

cumulative exposure to chemicals as well as low dose and long term effects on health and

environment. These issues are considered as major challenges, not sufficiently managed by current

policy, while concerns and attention to them is growing.

A review of currently available methodologies and systems have identified various components that

will be required in order to develop an operational warning system for the EU, one aimed at

proactively identifying new and emerging risks of chemicals. In general, the phases presented below

have been identified. An EU early-warning system should first be able to filter signals from the media,

scientific literature, and experts and to evaluate those signals. This could also include screening and

monitoring data. The second step should be to check if the signal has been identified previously and if

actions or regulatory measures have already been implemented and if so deemed sufficient. A third

step, based on target-specific criteria, would include the gathering of additional exposure, hazard and

policy data regarding these risks for discussion by experts. Subsequently, the data could be translated

into a risk score, thereby prioritizing newly identified risks of chemicals and finally defining the risk

management options (RMO) required and/or identifying the most suitable actor to address the risk.

In-depth analysis of existing systems

In general, two basic methods can be distinguished. The proactive “exposure first” method would aim

to identify possible new and emerging chemical risks (NERCs) based on physical, chemical, and

toxicological properties of a substance and/or the (altered) exposure resulting from the use of a

substance, taking technological and societal developments into account. The second method is the

“disease first method” (or “effect first method”). This is a reactive method that tries to identify

environmental and health effects of NERCs as soon as possible. The “disease first” method is

complementary to the “exposure first method”.

Environment

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Only two operational systems were identified that aim both at the identification and management of

new or emerging risks of chemicals (NERCS) for the environment – the NORMAN network (2016)

and the NERC system operated by the RIVM. Both non-institutionalized systems are currently

operational in the EU and are discussed in greater detail below. In addition, a more general approach

to the identification and prioritization of emerging issues is presented.

NORMAN is a network of reference laboratories, research centers and related organizations for the

monitoring of emerging substances. It systematically collects monitoring data and information on the

effects and the hazardous properties of substances. Based on this information, the substances are

assigned to priority action categories. A set of criteria is used for the allocation of emerging substances

to these clearly pre-defined categories and their subsequent prioritization. The ultimate aim is that

substances are selected to be put on the Watchlist of the Water Framework Directive 2000/60/EC. The

list of substances to be considered for prioritization is established through expert consultation and

chemical analytical methods. An example of the latter is non-target screening; a method aiming at a

broad detection and identification of chemicals that is not directed to a specific set of chemicals.

Action is taken when there is clear evidence of actual environmental effects. The method could,

therefore, be characterized as “effects first”.

The system operated by the RIVM uses online media monitoring, expert consultation and non-target

screening for the identification of new or emerging risks. A hazard and exposure based approach is

used to provide further evidence on the possible risk and derive a risk score in order to prioritize. A

variety of information sources are used to provide information on the possible exposure and hazardous

properties of the potential new or emerging chemicals identified. Highly prioritized chemicals can,

then, be proposed for a risk management option analysis under REACH for instance. Based on this

analysis, the most suitable risk management measure within REACH or other legislation would be

determined. The method allows to identify substances and undertake action before an effect occurs, for

instance based on identified hazardous properties, as well as to identify substances with clear

environmental effects, based on observed effects or exceedance of quality standards, resulting from

the evaluation of monitoring data. This system uses the “disease first” method, complementary to the

“exposure first method”.

Thirdly, the work done by the Scientific Committee on Emerging and Newly-Identified Health Risks

(SCENIHR) is largely based on expert consultation. Two parallel and complementary approaches may

be used to identify emerging issues: (i) a proactive approach that requires ‘brain storming’ sessions to

identify the emerging issues of principal concern followed by the introduction of procedures to detect

and characterize their development; (ii) and a more reactive approach based on the identification of

indicators of change and the monitoring of these to detect emerging issues.

SCENHIR proposes a decision tree approach (algorithm) for the identification and prioritization of

NERCS, based on qualitative criteria such as uniqueness, soundness, and scale of severity.

Workers

In relation to chemicals at the workplace, proactive “exposure first” methods aim to identify possible

NERCs, based on a proper risk assessment. However, for most substances the necessary information

to use deductive reasoning is lacking. This holds especially true for toxicological information

regarding the routes of exposure that are important for workers, i.e. inhalation and dermal exposure

(most available toxicological information is for oral exposure). Therefore, an inductive way of

reasoning is needed to identify and handle substances that have a negative impact on worker’s health;

i.e. “the disease first” method. This inductive way of reasoning works from observations (cases of

diseased workers) toward generalizations and theories. The “disease first” method is used, for

instance, in pharmacovigilance. Drugs are tested thoroughly prior to their introduction onto the

market, but the identification and evaluation of negative health effects reported after their introduction

onto the market is still needed.

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Considering the “disease first” method, there are systems based on expert forecasts. One review

consists of an overview of more than 40 (potential) NERCs for workers reported over the last few

decades using several data sources. A method for prioritization of these NERCs is presented in Palmen

and Verbist (2015). As part of the current sub-study, a survey was carried out among European

countries to get an overview of existing early warning systems for workers. This revealed three

different methods within the “disease first method” category:

- ‘clinical watch system’ for the collection of spontaneous reported cases in Europe;

- databases that may be used for epidemiological research on possible relationships between

occupation and/or exposure to substances and health effects (e.g. occupational cancer);

- biomarkers for exposure and/or biomarkers for biological effects that can be used to detect

NERCs.

One limitation of such a system can be the long response time between exposure and observed effects.

This can be addressed partly by detection of more sensitive effects or end-points by using for instance

biomarkers.

No typical system using the “exposure first” method has been identified for workers.

Consumers

Several systems or organizations, which deal with new and emerging risks of chemicals in food or

consumer products (toys, cosmetics and household cleaning products), were found to be of potential

use for the possible layout of a future EU-wide, sector-specific early warning system for consumer

protection.

The systems that exist at present highly depend on observed and documented signals relating to

occurrence of effects and potential exposure. Cosmetovigilance systems such as the European

Cosmetovigilance and the Dutch Consumer Exposure Skin Effects and Surveillance and the national

poison centers provide valuable information on the epidemiology of adverse effects, intoxications and

poisoning incidents that can be used to pick up a signal and to take measures.

The EU-wide Rapid Alert System for dangerous non-food products (RAPEX) enables quick exchange

of information about dangerous products found. The reports in RAPEX deal mainly with the failure of

compliance with regulations, thus mainly regulated products and chemicals. In a sense, this system is

pro-active as it aims to prevent harmful effect resulting from product failure or products not being

compliant.

The European Food Safety Authority (EFSA) seems, so far, to have the most advanced early warning

system regarding food related consumer exposure. This EWS is aimed at proactively identifying a

(re)emerging hazard and, consequently, preventing the presence of this hazard from giving rise to a

risk by taking preventive measures. Trends in indicator values and a variety of information sources

such as monitoring and scientific data are combined and evaluated to identify an emerging risk within

a network of experts. The key characteristic of this system is that it is anticipatory, rather than

responsive. It is different from rapid alert systems such as the Rapid Alert System for Food and Feed

(RASFF) where notifications are triggered by controls or consumer complaints.

Conclusions

Several approaches can be taken to pick up signals, such as online media monitoring and expert

consultation or registration systems for the collection, evaluation and systematic monitoring of

spontaneous reports of undesirable events. The systems that exist at present highly depend on

observed and on documented signals relating to occurrence of effects and potential exposure, the so-

called “effect based” or “disease first” systems. Some systems contain elements that can be used to

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proactively identify possible NERCs, based on a proper risk assessment, the so-called “exposure first”

methods.

Many data sources are already available that can be used to provide further evidence for the selection

or prioritization of potential new or emerging risks related to chemical substances. The selection of

suitable approaches for picking up signals and prioritization should be based on effectiveness and

efficiency. Generating an overview on existing data sources, their availability, accessibility, and their

usefulness would be essential to establishing an EWS. Subsequently, the data would have to be made

accessible through a central database. A quantitative risk based procedure, based on hazard assessment

and exposure assessment, is common in the field of risk assessment of chemicals for human health and

the environment. An alternative way to identify or prioritize new or emerging risks, such as those

proposed by SCENIHR, is based on identifying possible NERCs, based on qualitative criteria.

Investigating and identifying appropriate risk management options, followed by communication of the

risks identified and the proposed measures are essential to managing the observed risks. It appears that

the component covering risk communication is not always well covered in existing systems, meaning

that there is limited or no information about a communication plan directed at decision makers and

enforcement authorities or notice to define the actions on how to communicate the results obtained.

The need to develop a communication plan (including by whom and how) should, therefore, be

addressed in the development of an early warning system in particular. Building an overview of

current environmental legislation and the risk management options they provide, including the

competent authorities, is the first step in formulating a communication plan.

Due to the many differences that exist between the fields of environmental, consumer, and worker

protection and the differences between and within Member States on how signals on new and

emerging risks are collected, processed and interpreted, it may not be feasible at this moment in time

to create a single system covering all the three fields. The overall advice, therefore, would be to utilize

existing systems as much as possible and to try to make interconnections and facilitate communication

at the Member State and European levels. The basic building blocks and steps as described above can

be used as a starting point to establish a European early warning system for identifying chemical

threats to human health and the environment.

There are several reasons why existing approaches are insufficient and effort at the European Union

level is needed. From the analysis of existing national and international tools and methods developed

and operated for the early identification of new or upcoming chemical threats it is concluded that the

continuous effort on screening and filtering of signals is essential for early identification, but thislabor-

intensive process also needs input from experts at the national level, which is currently not organized

and coordinated at the EU or international level. Furthermore, it will always be hard to establish a

causal link between exposure to chemicals and, for example, diseases. One issue relating to this is the

limitations of epidemiology, meaning that a harmful effect must often be rather drastic and widespread

in order to be detectable. There is often a lack of information due to the absence of relevant hazard

data as well as the absence of exposure and use information. Therefore, it is important to identify all of

the useful sources of information and databases that are available, and to centralize this information as

much as possible in order to come to an effective and efficient procedure for the evaluation of the

signals collected and identifying new or emerging risk of chemical.

An EU or international platform, working continuously on the identification of chemical threats and

applying different approaches for collecting these signals appears to be lacking. In general, there is

need for more cooperation and exchange of information at the EU level on NERCs. An overall integral

approach, covering identification, finding further evidence, and proposing appropriate risk

management measures at the EU level is needed in order to facilitate progress towards a non-toxic

environment, but currently seems to be missing. However, at the national, EU and international levels,

there are various initiatives in the area of early identification, data collection, and in the management

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of chemical threats that could possibly connect well to the establishment of an early warning system.

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1 INTRODUCTION

Chemicals regulation in the European Union aims at the safe use of chemicals and protecting man and

the environment through predicting the hazardous properties and by limiting exposure through risk

management measures. Despite the various kinds of legislation, numerous well-documented cases

exist of extensive damage to health and environment caused by the production and use of chemicals.

Furthermore, it often takes a long time for societal institutions to pick up on these warning signals, and

even longer for them to react.

For example, 10 of the 15 Late Lessons from Early Warnings identified by the European Environment

Agency (EEA, 2002 and 2013) are directly linked to chemicals with hazardous properties (i.e.

benzene, asbestos, PCBs, halocarbons, DES, antimicrobials, MTBE, PFAS, TBT, EDCs). Half of

those cases highlighted issues caused by the persistent nature of chemicals (i.e. PCBs, halocarbons,

MTBE, PFAS and TBT), several emphasized the additional risks induced by the cumulative effect of

hazardous substances (i.e. PCBs, halocarbons, MTBE, TBT, EDCs), and two underlined the impacts

of late lessons on vulnerable groups (i.e. PCBs, EDCs). Furthermore, instances are highlighted in

which years or decades spanned before regulatory intervention.

Therefore, the early identification of chemical threats to human health and to the environment is of

great importance in taking timely measures to prevent, reduce or to eliminate the risk of hazardous

compounds.

This interim report describes the current methodologies in finding new and/or emerging risks

(NERCs) for the protection of workers, consumers and the environment. A key goal is the

identification of a generally applicable methodology to finding NERCs for each of these three

protection groups. In light of the differences in the finding and evaluation of NERC signals, the

feasibility of such a universal approach must also be addressed.

A range of tools, methods and activities have been drawn up, developed or initiated for the early

identification of new or forthcoming chemical threats. These tools and methods are commonly known

as early warning systems (EWS) or Rapid Response Systems (RRS). The report presents key findings

from the literature review of the existing projects and studies on Early Warning Systems for

anticipated chemical threats, together with the outcomes of the Workshop ‘Strategy for a non-toxic

environment’ held in Brussels on 8/9 June 2016.

The study on existing early warning methods and systems intends to provide:

An overview of existing projects and studies in the area of EWS that could be of use in the

development of an EWS for chemical risks;

Insight into the different aspects for consideration in establishing an EWS for chemical risks,

including components that already exist or would need to be developed;

An overview and discussion of the remaining gaps and deficits in respect of such an an EWS;

An overview of possible improvements and options for the set-up of a useful EWS.

Problem Statement

Despite the various kinds of chemicals legislation in the EU, numerous well-documented cases exist

of extensive damage to health and environment caused by the production and use of chemicals.

Furthermore, it often takes a long time for societal institutions to pick up on these warning signals,

and even longer for them to react. Therefore, the early identification of chemical threats to human

health and to the environment is of great importance in taking timely measures to prevent, reduce or

to eliminate the risk of hazardous compounds.

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Problem Statement

Developing an early response system for detecting and tackling approaching chemical threats to

human health and the environment should be regarded as a complementary action, a kind of safety

net, and not as an alternative instrument to replace current legislation.

The aim of an EWS is to identify; as early as possible, those chemicals that may be hazardous and

cause adverse effects. Early identification of emerging issues can be very valuable in maintaining a

high level of public safety and environmental protection. Early identification provides more time

for investigation or the implementation of appropriate measures to prevent or control the issues of

concern. A systematic approach for the early identification of chemical threats could also contribute

to identifying gaps in existing legislation, as well as data and knowledge gaps, or to informing

enforcement authorities or other stakeholders of the acquired information to . In this way, an EWS

could facilitate progress towards a non-toxic environment.

An EWS should take a systematic, proactive approach and aim to provide additional evidence,

insight into the appropriate risk management options, and communicating this information to the

relevant authorities or other stakeholders to enable them to act voluntarily or proactively.

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2 OVERVIEW OF THE STATUS QUO

2.1 DEFINITION AND SCOPE OF AN EARLY WARNING SYSTEM

Two critical aspects to consider when establishing, organising, and operating an EWS are: (a) the

definition of new and/or emerging risks and (b) the system’s specific aim or aims. This pre-defines the

scope of the system, i.e. what it will be able to do, as well as setting limits on the kinds of information

used and the outputs generated.

Those working in the area of EWS (e.g. European Food Safety Authority (EFSA) 2009 and 2014a;

U.S. Environmental Protection Agency (US-EPA), 2008; Network of reference laboratories, research

centres and related organisations for monitoring of emerging environmental substances (NORMAN

Network), 2016 and Scientific Committee on Emerging and Newly Identified Health Risks

(SCENIHR), 2009) use a variety of terms and definitions, such as new risk, emerging risk, emerging

issue, emerging pollutant, emerging substance, and contaminant of emerging concern. These can be

grouped into three main categories:

Newly created risk;

Newly identified risk;

Increasing risk or risks becoming widely known or established.

The typologies of NERCs used in this study were adapted from the European Agency for Safety and

Health at Work (EU-OSHA) [EU-OSHA, 2009]. These are presented in Table 1 below.

Table 1: Typologies of new and emerging risks of chemicals

New risks Emerging Risks

Risk caused by new types of substances on the

market, new processes, new technologies, new

types of workplaces, new types of exposure

routing; social or organisational change;

environmental changes.

An issue is newly considered as a risk due to a

change in social or public perceptions.

New scientific knowledge allows a longstanding

issue to be identified as a risk.

Number of hazards leading to the risk is growing.

Likelihood of exposure to the hazard leading to the

risk is increasing, (e.g. exposure degree and/or the

number of people exposed).

Effect of the hazard on the environment, the health

of workers or consumers is worsening.

More information on an issue becomes available.

This study focuses on the risks posed by chemicals to human health and the environment. The kinds of

chemicals covered are used as, or in, industrial chemicals, biocides, pesticides, food and feed

additives, cosmetics, medicines, metabolites, and by-products (e.g. from combustion and material

(dust) generated by high energy treatment of solids substrates). The different environmental

compartments affected are air, water and soil. Human exposure might occur via the environment,

consumer products, food, and exposure to chemicals at the workplace.

2.2 GENERAL APPROACH OF AN EARLY WARNING METHODOLOGY

Based on the existing methods and tools developed by the Food Agricultural Organization of the

United Nations (FAO, 2006), Dulio and von der Ohe (2013), SCENIHR, 2009 and the National

Institude of Public Health and the Environment in the Netherlands (RIVM, Hogendoorn, 2014 and

Palmen, 2016) the following five steps of an EWS can generally be identified (see Figure 1 below).

These steps are further explained in the sections below.

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Figure 1: Steps involved in an EWS

The first step, picking up signals, involves searching and tracing information on new or emerging

chemical risks and their possible related effects, using various sources (e.g. scientific literature, news

sites, websites, electronic databases and stakeholder networks). For risks to humans (workers or

consumers), epidemiological research and case reports are also valuable sources of information. While

clear criteria help the process of filtering out relevant signals, initial expert assessment is an essential

factor in the signal evaluation process (Palmen, 2016 and Hogendoorn, 2014).

The next step is to check if the signal has been identified previously and, if so, whether actions or

regulatory measures have already been implemented. This could lead to an immediate follow-up

action, such as informing enforcement or inspection authorities, depending on the kind of signal. If the

identified concern is already sufficiently covered and there is no need for further enforcement actions,

additional information collection and prioritisation is considered unnecessary.

During the next step, ‘signal strengthening’, additional evidence should be obtained, including expert

consultation, in order to assess the causality between the chemical exposure and the harmful effect.

A ‘prioritisation of risks’ then follows, in which an indication of the severity of the risk will be

provided based on the information obtained during the ‘strengthening of signals’. The prioritisation

step will result in a list of potential NERCs requiring a follow-up procedure.

Finally, follow-up measures are defined, including derivation of a safety limit (e.g. Scientific

Committee on Occupational Exposure Limits (SCOEL) for worker risks) and actions to be taken, for

example under Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) or

Classification, Labelling and Packaging of substances and mixtures (CLP) legislation, e.g.

authorisation, restriction, or harmonised classification and labelling) or by making use of, or adapting,

other relevant legislation.

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2.2.1 Detecting signals

For each protection target (the environment, consumers, workers), the first crucial step is to pick up

signals on new or emerging threats posed by chemicals, then finding and collecting relevant

information on the potential NERC. For workers and consumers, this requirement focuses on the

collection of data on adverse health outcomes related to exposure from various sources, thus providing

an overview of chemical stressors. Based on this data, well-known chemical stressors may be

identified, for instance in new types of products, as well as new chemical risks, i.e. new hazardous

properties previously undiscovered or not associated with a particular substance.

In practice, the process of identifying NERCs varies slightly for each protection target. For workers,

the identification process of a NERC is usually triggered when an adverse health effect is observed in

workers and there is a likely causal relationship with specific chemicals at the workplace. In the case

of consumers, the identification of a NERC is often based on the collection of information on an

adverse human health effect caused by exposure to consumer products containing a variety of

substances, which might eventually lead to the identification of the chemical(s) causing the adverse

effect. For the environment, the identification of a NERC is usually severely hindered by the presence

of numerous other compounds with highly fluctuating concentrations. This makes it very difficult to

determine causality between an observed adverse effect and a single target chemical (NERC). The

same is true for humans indirectly exposed via the environment (air, drinking water and food). This

reactive approach – the so-called ‘disease first’ method – tries to identify environmental and health

effects of NERCs as soon as possible after an adverse effect has been reported. The proactive

‘exposure first’ method, by contrast, would aim to identify possible new and emerging chemical risks

(NERCs) based on all physical/chemical/toxicological properties of a substance or the (altered) use of

a substance, taking technological and societal developments into account. It is important to be aware

of the differences in routing and evaluation in the identification of a NERC and these are further

described in Chapter 3 of this report. After the collection of data, an evaluation and/or expert

judgement will be necessary in order to identify NERCs that require a follow-up action to reduce or

eliminate the risk.

A general scheme for the identification and evaluation of signals of possible NERCs for the three

target protection groups is illustrated in Figure 2 (Hogendoorn, 2014).

Figure 2: General scheme for the tracing and evaluation of NERCs

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Several methods or tools are used to pick up or generate signals, such as foresight approaches,

monitoring and sampling, citizen science, and online media monitoring (Science for Environmental

Policy, 2016). Some of the methods are briefly outlined below, providing an overview of the different

possibilities rather than an indepth analysis of their efficiency and effectiveness.

Foresight approaches are, essentially, expert consultations, where a team of specialists and academics

works together to identify important future threats, such as the Delphi method (systematically

developing expert consensus on future developments and events). Also in this category is scenario

planning, which can usefully be combined with the Delphi method to detect emerging risks. Scenario

planning is about describing potential future challenges and is not a prediction of what will happen in

the future. Another approach is horizon-scanning; this aims to spot signals, watch trends and make

sense of the future. This includes, for example, forecasting trends in the use of new chemicals and new

applications of chemicals based on the development of new technologies.

Monitoring and sampling covers several techniques, such as chemical analysis of the known chemicals

in the environment in order to keep track of changes. Another technique is non-target screening, used

to detect chemicals that are not covered by the standard monitoring programmes. It is a method for the identification of environmental pollutants without having to first identify the compounds of interest.

Methods like bioassays and biomonitoring identify the biological activity of chemicals or monitor and

link specific chemicals to measured effects in (living) organisms in order to identify chemicals of

concern. An example of a biomonitoring programme is the European Human Biomonitoring Initiative

– HBM4EU (EC, 2017)

Citizen science or community-based monitoring uses the community to detect certain kinds of

information, e.g. environmental hazards (air concentration of pollutants), weather information

(precipitation, temperature), information on the occurrence of animals and plants (invasive species,

bird counting, etc.). Citizen science uses modern technology like smart phones, such as in the iSPEX-

project (iSPEX-EU, 2016) and internet communities such as Observation International, 2016 or the

UK Environmental Observation Network (UKOEF, 2017). This information can be collected at an

higher level (European Union) using national focal points and national reference centres, as in the case

of the European Environment Information and Observation Network (EEA, 2016)

Screening online media - such as online news, scientific publications and social networks - by

applying software that uses algorithms and structured search terms for picking up relevant signals that

can also give an indication of a new or emerging risk. A variety of public tools exist, e.g. the European

Media Monitor (EMM, 2016), or the International Biosecurity Intelligence System (IBIS, 2016), while

commercial tools such as HowardsHome Monitoring and Coosto are available to screen digital media

on the internet.

2.2.2 Signal strengthening and priority setting

‘Signal strengthening’ aims to collect additional evidence, including expert consultation, to assess the

causality between the chemical exposure and the reported harmful effect. Evidence requires both

information on exposure and hazardous properties of chemicals, or the discovery of similar cases. In

view of the ‘exposure first’ method, there is no link with observed effects at that point in time.

Nonetheless, the aim is to find evidence of possible adverse effects or hazardous properties of the

chemical in question.

A ‘prioritisation of risks’ then follows, in which an indication of the severity of the risk is given, based

on the information obtained. The prioritisation step will result in a list of potential NERCs requiring a

follow-up procedure. In practice, the causality assessment and prioritisation are simultaneous and

complementary processes.

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Several different approaches are used to rank the relevance of a potential chemical of concern. In

general, a risk-based approach is applied, using various kinds of information on the exposure and

hazards of that particular chemical. The information used in prioritisation depends on the availability

and accessibility of data, as well as the amount of effort required to generate specific data, such as

measured and modelled exposure concentrations or Quantitative Structure-Activity Relationship

(QSAR) estimates for hazardous properties. Ranking of the potential risk can be carried out by

applying exposure or hazard categories (high, medium or low) to the data obtained. (Hogendoorn,

2014; Palmen and Verbist, 2015; Schuur and Traas, 2012; ECHA, 2010 and 2014; Ohe et al., 2011;

Dulio and von der Ohe, 2013; Kuzmanović, et al., 2015; Mitchel et al., 2013; Guillén et al., 2012). An

inventory of potential data that can be used for prioritisation purposes is therefore particularly

important. Each parameter must be assessed: both the data source and its availability should be

indicated, together with the actions and amount of effort needed to gather or generate specific type of

information.

Several potential data sources and platforms have been considered here, such as IPChem (2016),

NORMAN network databases (NORMAN, 2016), EASIS (2016), EXPOCASTTM

program (Egeghy et

al. 2011; Mitchell et al. 2013; Wambaugh et al. 2013) and the MODERNET network (Palmen, 2016).

Some of these are solely data sources, some address data gathering, risk assessment, and prioritisation,

others tend to be used for the early identification of new and emerging chemical risks.

Table 2 provides a short overview of the data on hazards, exposure and risks that might be used in the

prioritisation of new and emerging chemicals. Different types of data can be used for both signal

strengthening and prioritisation, e.g. measured data, data based on modelling or statistical methods,

and data based on expert judgement. By its nature, each type of data has a degree of uncertainty, and

this must be reflected in scoring or characterising the potential risks that have been identified. In

setting up its EWS and prioritising NERCs (Hogendoorn, 2014), RIVM applied a qualitative indicator

to the degree of uncertainty.

Table 1: Overview of potential data sources that can be applied in prioritisation

Description Data Source Degree of uncertainty

Hazard

Environmental and occupational quality

standards, limit values etc.

Legislation (Water Framework

Directive (WFD), Air Quality Directive,

etc.)

Low

Predicted no effect concentration, no

observed effect levels, etc.

REACH registration data Medium

Hazardous properties C&L notification and REACH

registration database at ECHA, EASIS

database. PBT assessments

Low

QSAR based assessment of hazardous

properties

QSAR models/software High

Hazard scores and prediction of potentials

or mode of action based on QSARS and

models

QSAR models/software High/Indicative

Exposure

Measured concentrations NORMAN databases, IPChem,

national databases

Low/Medium

Production volumes REACH registration database at ECHA Low/Medium1

Modelled worker exposures (inhalation and

dermal)

ECETOC-TRA, Stoffenmanager,

Advanced Reach Tool (ART), and

others

Medium/High

Modelled concentrations based on

emissions and used volumes

SOLUTIONS project Medium/High

Exposure categories (environmental

release categories, process categories,

etc.)

ECHA registration database Indicative2

Risk

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Description Data Source Degree of uncertainty

Measured data case by case, accidents Low

Epidemiology Low-High

Modelled results from risk assessments Risk assessment reports, chemical

safety assessments (CSA), REACH

registrations

Medium/High

1 The exact production volumes are not publicly available but are usually provided in ranges. Class widths generally cover a

factor of 10: 1-10; 10- 100; 100-1,000, etc. 2 The exact share of the different uses of the total (production) volume is unknown; main use should be identified, with broad

exposure categories.

2.2.3 Follow-up actions and communication

In the final step, (see Figure 1 and 2) after identifying and determining a NERC, follow-up actions

have to be indicated, including possible risk management measures and a communication strategy. For

example, the REACH Regulation includes some possible risk management measures which could be

utilised to address an identified risk.

For a quick and appropriate response, an EWS should ideally pre-define or inventory the possible risk

management measures to be triggered, e.g. by identifying the types of chemicals to be covered

(industrial chemicals, biocides, cosmetics, etc.), the relevant risks (safety or health related), the pieces

of legislation that address these risks and the risk management options within each piece of legislation

(restriction, authorisation, enforcement, etc.). Finally, each measure should also identify the

appropriate authorities to be informed.

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3 LITERATURE REVIEW

A literature review was carried out of the existing projects and studies on EWS for anticipated

chemical threats in order to gain an insight into those that might prove to be useful in the development

of an EWS and to provide an overview on the different aspects to be considered in such a system,

including those components that already exist or those that would need to be developed. The review

was also designed to ascertain the remaining gaps and deficits that would impact on the establishment

of an EWS, as well as an overview of the improvements needed and the viability of setting-up a useful

EWS.

In order to extract information in a consistent and useful way, the literature selected was evaluated

through the checklist shown in the text box below.

The individual responses for the systems examined in this way are presented in Appendix 1, which

also includes an interview with the Dutch National Poisons Information Centre (NVIC), using the

same questionnaire. The following three sections discuss the results of the review for each of the

relevant policy areas.

Questionnaire for reference

1. What is the name of the system /registry/instrument? 2. What is the goal of the system/method/instrument/ methodology/ database? 3. Is it aimed at identifying possible (new and emerging) risks? Or can it be used for that goal? 4. Which organisation collects the information on possible (new and emerging) risks? 5. Which language is used in the system? 6. Is it available publicly or not?

a. Scale (national, EU, intercontinental) b. Compartments (air, water, soil, consumers, workers, industrial chemicals, biocides,

cosmetics, etc.)

7. What definition is used for new or emerging risks? 8. In which way are signals on possible (new and emerging) risks collected?

a. Automated procedure, expert judgement, expert panels, internet communication platforms

b. Type of sources consulted (newsletters, databases, digital media, scientific papers, symposia, etc.)

9. Are possible (new and emerging) risks collected in some way (national database)? How is the registration done?

10. How is the first report of a possible (new and emerging) risk evaluated and what criteria are used to evaluate reported signals?

a. Level at which automated procedures, expert judgement, manual work, is needed 11. Who evaluates the first report of a possible (new and emerging) risks? 12. Is there a plan for communication of a (new and emerging) risk between the reporter/notifier

and the evaluating body? Which evaluating bodies are in contact?

13. How does the evaluation and start/set-up of follow up for a possible (new and emerging) risk take place?

14. What were the costs involved in the set-up of the system? What does the maintenance of the system cost?

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3.1 EARLY WARNING SYSTEMS FOR ENVIRONMENTAL PROTECTION

The literature review revealed only two operational systems that aim to both identify and manage new

or emerging risks of chemicals (NERCs) for the environment: the NORMAN network (2016)1 and the

NERC system operated by the RIVM (Hogendoorn, 2014). Both systems are currently operational

within the EU and are discussed in more detail below. A more general approach to the identification

and prioritisation of emerging issues (SCENIHR, 2009) is included, as are the screening and

prioritisation approaches of ECHA and Member State authorities under REACH, and which cover the

environment, public health and occupational health.

The NORMAN network is a non-profit association of all interested stakeholders in the field of

emerging substances. The goal of the NORMAN network is to enhance the exchange of information

on emerging environmental substances. It encourages the validation and harmonisation of common

measurement methods and monitoring tools to better meet the requirements of risk assessors and risk

managers. The NORMAN network (2016) distinguishes between emerging pollutants and emerging

substances. ‘Emerging substances’ can be defined as substances that have been detected in the

environment but which are currently not included in routine monitoring programmes at EU level and

whose fate, behaviour and (eco)toxicological effects are not well understood. ‘Emerging pollutants’

can be defined as pollutants that are currently not included in routine monitoring programmes at the

European level and which may be candidates for future regulation, following research into their

(eco)toxicity, potential health effects and public perception, and analysis of monitoring data on their

occurrence in the various environmental compartments. According to the NORMAN network,

emerging pollutants are any substances introduced into the environment that adversely affect the

usefulness of a resource or the health of humans, animals, or ecosystems. In that sense, emerging

substances are potentially emerging pollutants but which lack sufficient information to either address

them as pollutants or deal with them through existing regulations.

To-date, the activities of the NORMAN network have chiefly addressed the requirements of the WFD.

Identified and prioritised chemicals are proposed as candidate substances for the EU Watch List of

substances for Union-wide monitoring in the field of water policy pursuant to Directive 2008/105/EC

of the European Parliament and of the Council (Article 8 of Directive 2013/39/EU).

The NORMAN network systematically collects monitoring data and information on the effects and the

hazardous properties of these substances in EMPODAT, a database of geo-referenced monitoring or

occurrence data on emerging substances. Based on this information, the substances are assigned to

priority action categories by the NORMAN Prioritisation Working Group, which is co-ordinated by

INERIS (France) and comprises experts from national authorities, industry and consultancies

The NORMAN network procedure for the classification of emerging substances is shown in Figure 3,

along with the steps to be followed.

1 http://www.norman-network.net/

http://www.norman-network.net/

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Figure 1: Norman network approach on finding NERCs in water

The list of emerging substances (NORMAN list) is compiled through expert consultation and then

augmented with substances identified from other NORMAN working group activities, such as the

working group on effect-directed analysis for hazardous pollutants identification, the working group

on non-target screening, and the working group on biomonitoring (bioassays and biomarkers).

A set of criteria is used for the allocation of emerging substances to clearly pre-defined categories (e.g.

substances for which there is not yet sufficient information about their toxicity, substances for which

there is evidence of hazard but analytical performance is not yet satisfactory, etc.), and their

subsequent prioritisation.

The criteria employed are frequency of occurrence, exceeding environmental quality standards (EQS),

and hazard information. The information needed for prioritisation is collected in the EMPODAT

database, and a high degree of manual work and expert judgement is necessary for the prioritisation

process.

The RIVM study (Hogendoorn, 2014) presents methodologies for finding and prioritising NERCs for

each protection group i.e. consumers, workers and the environment. It also suggests measures to

reduce exposure to the selected NERCs in the short-term. Although there are methodological

similarities in the identification of NERCs for each protection goal, the complexity and route of

exposure of NERCs requires different approaches to identification and risk management in each case.

The separate pathways for each protection goal are illustrated in Figure 4, which shows the approach,

the steps involved, and the process of linking information. The common features are at the level of

methodology. Common and different types of sources are explored for signalling (e.g. scientific

literature, news sites, websites, electronic databases, stakeholder networks) and for gathering and

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evaluating information, involving international networks of experts to assess the causality between the

chemical exposure and the effect. The approaches for worker and consumer-related NERCs will be

discussed in Chapters 3.2 and 3.3 of this report.

Figure 2: Schematic of the approach to the tracing of NERCs (Hogendoorn, 2014)

The NERC system operated by the RIVM is not aimed at any specific piece of legislation in the field

of chemicals. The focus for the environment - until now - has been the aquatic environment.

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The system operated by the RIVM (Hogendoorn, 2014) uses online media monitoring, expert

consultation and non-target screening for the identification of new or emerging risks. The European

Media Monitor (EMM, 2016) is used to screen digital media by applying a specific set of search

terms. In addition to the EMM, a weekly newsletter is generated by using HowardHome Monitoring to

screen online news sites and scientific literature. A web-based expert platform has been set-up to

facilitate discussion and information exchange on new and emerging risks, as well as new analytical

techniques or tracing them. Two projects have been carried out, applying non-target screening for the

identification of new or emerging chemicals in the aquatic compartment. A substantial set of

substances was identified as potential new or emerging chemicals (Kolkman and ter Laak 2012; Sjerps

et al, 2015).

To derive a risk score for prioritisation, Hogendoorn (2014) uses a hazard and exposure based

approach. Various sources provide information on the possible exposure and hazardous properties of

the new or emerging chemicals in question. The information used ranges from environmental

monitoring data to proxies for potential exposure, such as use-based exposure categories and

production volume. Identification of hazardous properties is based on existing EQS or no effect levels,

the classification of substances as carcinogenic, mutagenic, and reprotoxic (CMR), ED, or an

assessment of these properties based on QSARs when no other information is available.

Some highly prioritised new or emerging chemicals were proposed for a risk management analysis

under REACH. Based on this analysis, the most suitable risk management measures within REACH

(substance evaluation, restriction, authorisation or harmonised classification and labelling), were

determined and further REACH activities and processes initiated.

The SCENIHR provides opinions on emerging or newly-identified health and environmental risks and

on broad, complex or multidisciplinary issues requiring a comprehensive assessment of risks to

consumer safety or public health and related issues not covered by other Community risk assessment

bodies. The work done by the committee is largely based on expert consultation and foresight

approaches. A position paper on emerging issues and the role of the committee (SCENIHR, 2009)

recognised two parallel and complementary approaches to identifying emerging issues:

A proactive approach by the SCENIHR. This requires ‘brainstorming’ sessions to identify the

emerging issues of principal concern, followed by the introduction of procedures to detect and

characterise their development; and

A more reactive approach based on the identification of indicators of change and their subsequent

monitoring in order to detect emerging issues.

The SCENIHR proposed a decision tree approach (algorithm) for the identification and prioritisation

of NERCs, as shown in Figure 5.

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Figure 3: Proposed algorithm for identifying priorities (SCENIHR, 2009)

The weighting of these criteria indicates that a health/environmental impact perspective is prioritised

in dealing with these issues, while final prioritisation by the Commission may be influenced by

political factors such as socioeconomic considerations and public concern. While this decision tree

approach is designed to be easy to use, it inevitably prioritises some criteria over others. This may be a

problem if the data for a particular decision point are inadequate. As experience is gained in its use, it

may require further development.

ECHA works together with the European Commission (EC) and the Member States for the safety of

human health and the environment by identifying the needs for EU-wide regulatory risk management.

The Member States or ECHA (at the request of the Commission) initiate the identification of

substances of potential concern. To this end, ECHA and the Member State competent authorities have

developed a common screening approach to systematically screen available information for substances

in the REACH registration dossiers (and other databases) and to identify substances for the different

REACH and CLP processes such as substance evaluation, authorisation and restriction (ECHA, 2015).

To focus the work under different REACH and CLP processes, the substances that matter most must

be identified, including those substances for which further information is needed to draw conclusions

on the hazards or risks they might pose, as well as substances for which further regulatory action

should be considered. Part of the regulatory process is risk management option analysis (RMOA). The

purpose of RMOA is to assist with a decision on whether or not further regulatory risk management

activities are required for a substance, as well as to identify the most appropriate instrument to address

a given concern. A Member State or ECHA (at the request of the Commission) can carry out this case-

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by-case analysis. Although RMOA is an important step, it is not part of the processes defined in the legislation.

Substances of concern are mainly those meeting the criteria for inherent properties (Article 57) and the

information according to Article 58(3), as set out in the REACH Regulation. Groups of substances

included are CMRs, sensitisers, PBTs, very Persistent, very Bioacumulative (vPvBs), ED, or

substances of equivalent concern. The screening or prioritisation processes are used to identify and

investigate substance-specific (and dossiers-specific) information, in order to make a preliminary

assessment on how to proceed. The focus is mainly on the criteria/properties defined in Article 57,

together with the criteria defined in Article 58 (3) relating to the use of a substance, such as market

volume, wide dispersion, and professional and industrial use (EC, 2013 and ECHA, 2014). Comparing

their structural similarity to substances on REACH’s Candidate List is one way to identify new or

emerging chemical substances. Inherently hazardous properties other than those explicitly mentioned

in Article 57 can also be included to address equivalent concern.

The primary goal is to identify and regulate substances of very high concern (SVHC) covered by the

REACH regulation. REACH, however, does not include all uses of chemicals but, rather, addresses

mostly industrial chemicals (including cosmetics) with a volume of one tonne or more, placed on the

market in the EU. Many kinds of chemicals regulated by other legislation fall outside the scope of

REACH, such as medicines, pesticides, biocides, food and feed additives and others. To some extent,

new or emerging risks can be identified and dealt with under REACH, despite the focus on those

substances registered, and the hazardous properties defined, under the REACH Regulation.

ECHA and Member States carry out collaborate screening for substances of potential concern, and this

process has many hallmarks of a system to identify and prioritise NERCs. It aims to find substances of

potential concern for both human health (consumers and workers) and the environment. REACH,

however, does not cover all chemical uses, and its regulatory processes focus on specific hazardous

properties and registered substances. There is less focus on the identification of new uses of chemicals,

newly identified hazardous properties of chemicals, or using monitoring data as a primary source to

identify chemicals of concern,. REACH has generated a large amount of useful data on uses and

hazardous properties of chemicals, as well as prompting the development of useful screening and

prioritisation methods and tools to streamline regulatory processes.

3.2 EARLY WARNING SYSTEMS FOR WORKER HEALTH AND SAFETY

The literature review includes six systems applicable to workers (see Appendix 1). Three of these are

expert forecast systems (EU-OSHA, 2009; EU-OSHA, 2013; SCENIHR, 2014) and can be regarded as

methods at a higher level, since the expert forecast is prompted professionals in the field (e.g.

physicians, occupational hygienists). One review consists of a summary of more than 40 (potential)

NERCs for workers reported in recent decades, using several data sources (Palmen et al, 2013). A

method for prioritisation of these NERCs is presented in Palmen and Verbist (2015). As part of the

current study on a strategy for a non-toxic environment, European countries were surveyed on their

existing early warning systems for workers (Palmen, 2016).

All workers are entitled to work in environments where chemical exposure-related risks to their health

and safety are properly controlled. Palmen et al. (2013) describe the chemical legislation relevant for

workers. According to the legislation, every employer whose workers may be exposed to chemicals

must carry out and keep a relevant risk assessment. The employer must take the necessary preventative

measures identified in this assessment, and risks must be eliminated or reduced to a minimum in line

with the hierarchy of prevention measures. However, despite all regulations, workers still suffer

detrimental health effects from occupational exposure to chemicals.

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In an ideal situation, all chemical hazards associated with a substance would be known prior to it being

placed on the market, in order to prevent negative health impacts for workers as a consequence of

chemical exposure at the workplace. This implies that all toxicological information is available for a

substance, including oral, inhalation and dermal exposure. In this scenario, deductive reasoning could

be used to link a reported health effect to occupational exposure. This proactive approach is called the

‘exposure first’ method2. It aims to identify possible new and emerging chemical risks (NERCs) based

on all physical/chemical/toxicological properties of a substance or the (altered) use of a substance,

taking technological and societal developments into account. No such ‘exposure first’ system is

typically used for workers.

For most substances, the information needed to use deductive reasoning is lacking. This is especially

true of toxicological information in respect of the routes of exposure for workers, i.e. inhalation and

dermal exposure (most toxicological information is available for oral exposure). Inductive reasoning is

therefore needed to identify and handle substances that have a negative impact on worker’s health, i.e.

the ‘disease first’ method. This inductive type of reasoning starts with observations of diseased

workers and moves towards generalisations and theories. The ‘disease first’method is reactive, and

tries to identify health effects of NERCs as soon as possible in order to prevent additional cases. The

‘disease first’ method complements the ‘exposure first’ method and is used in pharmacovigilance.

While drugs are tested thoroughly prior to their introduction on the market, negative side effects are

often found following their introduction, necessitating the ongoing identification and evaluation of any

negative health effects.

The ‘disease first’ approach requires the use of several complementary methods. Active detection via

health surveillance, active literature search using text mining, and secondary analysis of other sources

should all be used to identify new and emerging risks, as should clinical watch systems3 and databases

with information on exposure and health effects (Palmen et al., 2013).

A good example of a ‘disease first’method is the expert forecast of NERCs by EU-OSHA (EU-OSHA,

2009). In this study, the Delphi method4 was used to identify NERCs highlighted by experts (see

Figure 6). Six literature reviews explored the main emerging risks in greater depth, particularly those

singled out by the forecast in terms of context, workers at risk, health and safety outcomes, and

prevention. This forecast gives an overview of the most important issues, according to the experts.

These experts need on-the-ground information from practitioners, those who actually see patients, as

well as seeking out data from the literature (reported cases, toxicological and epidemiological

research). This type of ‘disease first’method is, again, an example of a higher-level method, since the

experts in the Delphi study do not have direct contact with professionals in the field who actually pick

up the first signals.

Looking ahead to the role played by NERCs in green jobs, EU-OSHA (2013) has identified the key

technological innovations that may be introduced in green jobs over the next 10 years, both those

which may lead to new and emerging risks in the workplace, and those that may have a positive

impact on workers’ safety and health. These health and safety aspects were defined by experts, based

on scenario building. This method may improve knowledge about key technological innovations,

thereby leading to the discovery of NERCs.

2 Personal communic

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