need for global thinking: the support of federchimica in ... · solvay ppt template - specialty...

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

© 2013 Solvay Specialty Polymers 2

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

• …


• Monitoring and compliance of world wide regulations can pose

changelles due to:

• complexity of regulations

• increasing supporting data requirements (in-country test)

• languages


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


• 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



• The international regulations have impact on the Business

• increased cost of business (testing…)

• delay in marketing

• decision to discontinue business in partial market


• 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


• 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?


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…


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


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


It is IMPORTANT to define a global strategy for registration


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


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?


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


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


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



Inventories and notification rules in the following countries:

Australia Canada China Korea Philippine Japan, New Zealand Serbia USA, Switzerland Taiwan Turkey

GER

© 2012 Solvay Specialty Polymers - 18 -

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


GER

Countries: USA

Canada

Japan

Australia

Philippines

China

Switzerland

Turkey

Information: rules for polymer exemption

PLC definition

form to be submitted


QUESTIONS ?

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