Need for global thinking: the support of
Federchimica in the international field.
Workshop Centro Reach – Milan, 3 Dec. 2014
Graziella Chiodini, Solvay Specialty Polymers – Italy
Team Leader GER -Working Group
Agenda
• International Chemical Control Laws
• Regulatory Compliance
• Federchimica: Global Emerging Regulation working group
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International Chemical control laws
• The chemical industries have to face a huge number of the
international chemical regulations:
• Hazard Communication: C&L, MSDS
• GHS adoptions and implementation: requires a lot of work and costant
maintenance
• Chemical inventories: influence of REACH in emerging countries
• RoHS
• Food Contact
• Biocides
• Waste
• Medical devices
• Cosmetics
• Stockholm Convention on POP
• Rotterdam Convention on the Prior Informed Consent Procedure for Certain
Hazardous Chemicals and Pesticides in International Trade
• Montreal Protocol on the ozone depletion chemicals
• …
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• Monitoring and compliance of world wide regulations can pose
changelles due to:
• complexity of regulations
• increasing supporting data requirements (in-country test)
• languages
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International chemical control laws
Regulatory surveillance process is the key step to assuring compliance
• Relevant laws and regulations and the responsible agencies
• Chemical inventory and registration procedures of new chemicals
• Timing, logistics and potential exemptions
• Import and export requirements
• Enforcement and penalties
International chemical control laws
• In the last 10 years there was an increasing number of new regulatory
schemes and amendments of the existing regulations
• General perception that the existing regulations were not adequate
• More stringent requirements driven by the need to manage risks
related to public health and environment
• Increasing interest in sustainability
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• The international regulations have impact on the Business
• increased cost of business (testing…)
• delay in marketing
• decision to discontinue business in partial market
International chemical control laws
• Development of an industrial strategic position must include
• regulatory compliance
• voluntary commitments
• Better knowledge of the hazards of substances and
identification of the appropriate risk management measures
to ensure their safe use.
• Higher protection for workers and environment
International chemical control laws
• A great has been written about REACH and TSCA
• What is doing in other parts of the world?
• Do other countries have chemical control laws?
• Are they similar to REACH?
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Some countries are developing chemical regulations that are
considered “REACH-like” that means they include Notification of new chemicals
Registration/or not of existing chemicals
Inventory based system combined with REACH-like elements
Periodic reporting of volumes
Data requirements depending on volume or hazard
Concept of recent “REACH-like” chemical control
regulations
• Some similarities but many differences (in important ways!)
• timing for notifications/ registrations
• tresholds
• exemptions available or not
• data requirements (local ecotox, acceptance of QSAR, defining product
composition/ impurities, etc)
• communication in the supply chain
• etc…
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What to do: think globally
1. Define your product and identify the markets
• new or existing chemical
• mono constituent or multi constituent
• industrial chemical
• consumer product
• sensitive applications (food contact; potable water..)
• biocides
• cosmetics…
2. Which countries?
for each country identify the laws,
the agency,
the local consultant
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What to do…
• Check if the substance is listed in the inventory
or if it is exempted
• If it is a new substance the first step is to ask to CAS Registry
Service for a new CAS number and name
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It is IMPORTANT to define a global strategy for registration
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For each country or region identify
• law(s) regulating your product(s)
• government agency/agencies
• stakeholders
• customers
• trade associations
• local experts/consultants
• company affiliates
• ensure CBI protection with non-company reps &
government departments
What to do…
• Authorities/Agencies evaluate new substances for potential impacts on
human health & the environment
• Typical data requirements
• toxicological
• physicochemical
• occupational exposure
• environmental release
• Time and expense for data generation, dossier preparation and review
period can vary from country to country
• Some countries requiere that the ecotox test are performed in the
same country
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Registration process
• The chemical legislations are complex and becoming ever more
complex.
• They involve substantial bureaucracy
• Many legal and policy issues have arisen
• Chemical Companies are required to dedicate effort, time and money
to the these topics
• What Federchimica is doing to help the italian chemical
companies?
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Working Group in Federchimica
• In May 2011 the Global Emerging Regulation Working Group was
created in Federchimica, within the Product Safety Area.
• Why?
• chemical companies operating in a global context must have
knowledge of the different chemicals control legislations
especially in emerging countries
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Working Group in Federchimica
Mission
• Monitor and understanding the emerging legislations in non EU
countries
• Facilitate the ability of companies to trade in world market in
compliance of legal requiremets
Activities
• Track legislation
• Working with trade associations
• Participating in conferences
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GER
GER
Federchimica GER members
• Associations: 6
• Federation: 4
• Industry: 40
Output:
Workshops in November 2011 “Global Chemical Regulations:
existing and new inventories”
Publications that are available in Federchimica website
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Inventories and notification rules in the following countries:
Australia Canada China Korea Philippine Japan, New Zealand Serbia USA, Switzerland Taiwan Turkey
GER
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Each card includes the following infiormation:
• The existing law (name, number, date of publication)
• Inventory name
• Name of the compertent Authority for the notification and the enforcement
• Need to have an agent or a legal representative
• Notification procedure including testing requirements
• Exemptions
• Fees
• IT tool or paper format for the submission – language
• Approval timing
• Usefull Links
GER
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GER
Countries: USA
Canada
Japan
Australia
Philippines
China
Switzerland
Turkey
Information: rules for polymer exemption
PLC definition
form to be submitted
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QUESTIONS ?