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In 2017/18, Chemical Watch is celebrating its 10 year anniversary. In this time, we have worked closely with the chemical regulatory and compliance community, informing businesses globally on product safety.

In 2007, when Chemical Watch started publishing news alerts, they contained perhaps a couple of stories. In 2017, on average, each one lists 30 or more. This trend is testament to the rapid evolution globally of chemicals regulation.

Companies continue to face unprecedented challenges in keeping up with and understanding new developments, and Chemical Watch will continue to provide

the best news and analysis on the market to help them.

One of our proudest internal metrics is that year on year since our launch we have maintained a subscriber renewal rate of over 90%. It tells us we are getting it right but also that there is a compelling need for the information we provide, which drives us to keep on getting better at what we do. We intend to reflect our customers’ loyalty.

To mark the 500th edition of our weekly News Alert (published on 24 August 2017), we have produced this keepsake collection of 10 stories covering some of the key milestones since Chemical Watch started reporting in 2007.

Keeping up with news and analysis 10 key articles from the past 10 years


10 key articles from the past 10 years

With nearly 3,400 phase-in substances

registered in 24,675 dossiers, and no

major technical hitches reported, the

first REACH deadline, which passed

at midnight last night, was described

as a success by authorities, industry

and some NGOs.

Geert Dancet, executive director of the

European Chemicals Agency (ECHA), said

“This is a momentous day – something that

many people inside and outside Europe

have been working towards since the

REACH regulation was published at the

end of 2006.” He congratulated companies

for rising to the challenge to comply with

REACH and not push for an extension

to the deadline, especially against the

backdrop of the difficult economic

situation. He also thanked colleagues in EU

Member States; the European Commission

for its support to companies; and to his

own agency and staff “who have performed

magnificently in enabling this to happen.”

He noted that the final number of

registrations and substances, including

a breakdown of ‘phase-in’ and ‘non

phase-in’, will be available when all

submitted dossiers have been processed

in the coming weeks. ECHA will regularly

update its list of substances intended to

be registered, which is published on its

website. In addition to identifying

registered substances, Mr Dancet said

the agency is committed to going through

the list to investigate why substances were

not registered and whether it is a concern.

He said the agency had agreed to do this

over the coming months for the REACH

Directors’ Contact Group. He acknowledged

that downstream users are nervous

regarding continued supply of materials.

But he said there were many reasons why a

substance had been on the list but had not

been, and did not need to be, registered.

One amendment to the overall registration

figure will come once substances and

dossiers submitted in 2008 and 2009 have

been added in to figures released today –

which just cover 2010 submissions.

Mr Dancet noted that there had been

a rush of registrations in the last week –

the number of dossiers submitted was

a record. But overall he said the submission

process and IT system had held up.

He added that in the last four hours of

registration, some 300 dossiers were

submitted, and that because many of these

were from more inexperienced companies

there was some “agitation”. However, with

the system it has installed, the agency said

it could see why submissions were failing

and it was able to telephone companies to

offer assistance. Still he said it appears 67

dossiers did not get through – including

one lead.

The agency has provided advice on what

companies should do next if they achieved

registration, or failed.

Mr Dancet said the process seemed to

have worked well for all players, including

SMEs and Only Representatives. While

approximately 86% of registrations were

made by large companies and 14% were

SMEs. Only Representatives of non-EU

manufacturers made 19% of registrations,

which, the agency says “demonstrates the

ability of non-European companies to

participate successfully in Substance

Identity Exchange Fora (SIEF).”

The number of companies seeking special

treatment under the solutions proposed

by the DCG was somewhat lower than

expected. Out of 50 companies that used

the webforms provided by ECHA, only

17 followed through with documentation.

In addition, the number of data or cost

sharing disputes were low – with a handful

relevant to the deadline.

One of the next key phases for the

registration dossiers is the dissemination

of the data. The agency is planning to add

Nearly 3,400 substances pass “momentous” REACH deadlineECHA to investigate shortfall in expected substance registrations

1 December 2010



substances to its current dissemination site

in the next few days – however, the bulk

of data will be uploaded automatically

from 1 March next year when it has fully

developed a data “extraction” tool. Mr

Dancet said the delay would also allow

companies to use the dissemination

plug-in tool to check for themselves what

data would be disseminated, and if they

should pursue a confidentiality claim. At

present the system is not set up to reveal

registrant identities, as this was ECHA’s

understanding of the Regulation. However,

Mr Dancet noted that the issue would be

discussed with the agency’s Management

Board and further legal advice would be

sought from the Commission. Mr Dancet

said the agency would be happy to change

the system to enable registrants’ identities

to be revealed, if necessary.

Another major challenge for ECHA is

handling the 1,548 testing proposals

contained in 580 of the submitted

dossiers; Mr Dancet expected it would

take about six months to publish all the

proposals prior to the public consultation

and discussion.

Regarding the international implications of

the first REACH deadline, Mr Dancet noted

that it was clear a number of agencies

around the world were now keen to

cooperate with ECHA. In addition to a

Memorandum of Understanding signed

with Canada earlier this year, he noted an

agreement with the US Environmental

Protection Agency would be signed in

two weeks time in Washington. In addition

discussions are taking place with Japan

and Australia.

Celebrating the deadline, Antonio Tajani,

European Commission vice-president and

Commissioner for Industry said companies

had taken up the challenge to comply with

high demands and tight deadlines: “We

should all be aware and grateful for the

effort.” He also thanked and congratulated

ECHA noting that “its staff, their

professionalism, seriousness and reliability

have made possible this first phase.”

He added that REACH reconciles the

objectives of competitiveness and

protection of consumers and the

environment and is “a notable advance

for our consumers and workers across

Europe, since they can now use most of

the volume of chemicals produced and

imported into the European market under

better conditions for health and

environment.”

While he described REACH as a pioneer

in many fields, and added that many

solutions had had to be found to problems

encountered on the way, he recognised the

difficulties faced by small and medium

sized enterprises (SMEs). He said they

should benefit from the registration system

as REACH provides for increased

communication within the supply chain,

but he said these benefits came at a price.

With the number of SMEs likely to be

impacted by the next two registration

deadlines in 2013 and 2018 set to be

much larger, he said: “We must learn from

this first step to see how to help them

overcome the [issues] as easily as

possible.” He appealed to large producers

and importers to treat SMEs in a fair,

transparent and non discriminatory way,

particularly in sharing costs associated

with the use of data owned by other

companies.

He also said the Commission would

monitor closely the possible disappearance

of certain substances from the market.

While not thought to be many substances

at this stage, he added: “there is a lot of

uncertainty about this.”

From industry’s perspective, Cefic

president Giorgio Squinzi commented:

“Today’s deadline is an important step

for the effective application of REACH.

I want to thank EU organisations,

particularly vice president Antonio

Tajani and Commissioner Janez Potočnik,

for their collaborative approach and wish

for cooperation to continue.”

The group used the occasion to ask for

REACH “to become less burdensome and

more workable as the next phases will be

more difficult, especially for small- and

medium-sized firms, and downstream

users.”

Mr Squinzi added: “We are already

focusing on phase two, as we want REACH

to become a success. All related existing

and future chemicals legislation must be

consistent and coherent with it.”

Erwin Annys, Cefic’s REACH director

noted: “it is a nice moment. But realistically

it is the first step, now we have to facilitate

the next steps.”

The metals group Eurometaux recognised

the day as “the first important registration

milestone under the REACH Regulation!” It

reports that its members have successfully

registered their substances manufactured

or imported over 1,000 tonne/year,

including a series of complex inorganic

intermediates. It estimates the European

non-ferrous metals industry has invested

around € 200 million to make REACH work

for its substances and to meet its

obligations under the Regulation.

To ensure “efficient and cost-effective

implementation of the next REACH

Requirements”, Eurometaux calls for:

» Stability of the legal framework

and avoidance of changes in the

interpretation of definitions, existing

guidance documents and concepts

» Balanced and pragmatic

implementation of the Regulation



» Reasonable timing for the

implementation of new and changed

rules and interpretations, such as for

intermediates and “strictly controlled

conditions”

» A proportional and realistic approach

to the review of the REACH Regulation

» Recognition of the data and knowledge

generated under REACH in chemicals

and other legislation

Meanwhile the service provider

REACHReady said it was redeploying its

expertise to help companies deal with the

fall out of registration – updating Safety

Data Sheets, communicating the presence

of Substances of Very High Concern, as

well as helping companies cope with the

effects of substance withdrawals. Its

director, Jo Lloyd added: “From the new

year we will also have the 2013 deadline

firmly in our sight and look forward to

helping our subscribers get their 2013

SIEFs moving as there is no time to waste.”

She added that people are asking why the

substance numbers fell some way short of

the 4,700 substances that were expected

to be registered in 2010. While she

thought it is unlikely that a complete

answer to this question would be found,

she made the following observations:

» Several of the missing substances have

been swept up under other EC numbers

as a result of the sameness discussions.

These include many sugars, petroleum

and coal distillates, natural extracts as

well as many residual substances listed

as slags and slops.

» Many of the substances on the list have

since been judged as exempt by the

SIEFs such as nicotine, natural gases

and some natural extracts.

» One thousand CMRs that met the criteria

for 2010 registration – as listed in Annex

VI to the CLP regulation – still appear in

ECHA’s 2010 list even though many of

these are no longer on the market.

Likewise many will be out of scope of

registration – either because they are

manufactured or imported in quantities

less than the 1 tonne/year or used in an

application outside of the scope of

REACH. Comparing ECHA’s 2010 [list of

substances intended to be registered]

and Annex VI to CLP reveals that some

400 plus of the known CMRs were not

registered.

ReachCentrum, the Cefic service provider

said that it managed 400 lead dossiers for

105 consortia.

Outside the EU, Lynn Bergeson of

Washington-based law firm Bergeson

& Campbell, who works closely with US

industry clients noted that ECHA had

provided good support, although she

believes the agency should have opened

REACH-IT for lead registrants “24/7” from

the beginning of the year. Further, she said:

“Those of us here in the US, encountered

the expected challenges posed by

currency issues. Conversion was not

error-free. We did have issues with the

ECHA fee tool. It was not available until

late in the programme.”

She added: “The global sense of urgency

contributed to problem solving and getting

the job done. That said, impacted entities

will likely start earlier on the 2013 deadline

in light of the 2010 experience.” She said

there was a “collective relief over getting

the job done, but industry was keenly

aware of the CLP deadline, looming large.”

Meanwhile, Richard Denison, senior

scientist at Environment Defense Fund,

stated: “This is 11 years in the making and

this represents a real watershed in modern

chemicals policy.” He said it had been most

interesting to watch the evolution or shift in

industry views that REACH has brought

about in Europe, and following that in the

US. Industry started off saying there is

not a problem, he said. But as REACH

was being formulated that shifted to

“this is not workable and will be too

burdensome.”

Then, as REACH moved through

Parliament we heard “it will never get

adopted; it will never be implemented or

enforced.” From there we have seen the

front edge of companies recognising the

business benefits of REACH.

He recounts how DuPont back in 2007

described REACH as a business

opportunity for a science-based company

like itself that would be innovating new

chemicals. And Evonik noted that the data

requirements under REACH were being

considered by some to be a problem but

that their company saw it as a blessing -

that the data could be used as the

evidence needed to market and defend

their products as safe.

He added that while there was still much to

do, REACH requirements for minimal data

sets, limiting the use of most dangerous

chemicals, and sharing information

throughout the supply chain is “irreversible

at this point. I think REACH has changed

the landscape radically.”

David Andrews, senior scientist at

Environmental Working Group added: “This

is very much an initial step in the process....

an important first step.” He added that the

milestone provides “a foundation from

which US chemicals policy can move

forward in a complementary fashion.”

The Humane Society International/Europe

commented that “millions of animals risk

being subjected to unnecessary toxicity

testing because the regulation has yet

to incorporate recently approved

alternative tests.”



Measures overhauling China’s regulatory

regime for the manufacture, storage and

transportation of hazardous substances

will come into force on 1 December

2011 following the recent publication

of a revised version of the Regulation

on the Safe Management of Dangerous

Chemicals. The changes were

announced in State Council Decree 591,

which was published on 12 March by

the State Administration of Work

Safety (SAWS).

The adoption of the revised regulation

gives legal force to two mandatory Chinese

national standards that introduce rules in

accordance with the second revised

edition of the UN Globally Harmonised

System (GHS) for chemicals classification

and labelling – GB 13690-2009 on the

general rules for the classification and

hazard communication of chemicals, and

GB 12528-2009 on precautionary labelling.

The standards were implemented on

1 May 2010 with a 12-month transition

period, and so should come into force on

1 May 2011; however the 1 December

date on which the decree enters into force

will take precedence – and it is possible

that, as on previous occasions,

supplementary guidance containing

transitional periods could be issued after

the date the decree comes into force.

The standards require companies to

classify chemical hazards and

communicate those hazards in accordance

with the GHS requirements, and give

examples of precautionary labels, transport

symbols and precautionary statements for

different categories of chemicals that

comply with these requirements.

The updated decree also introduces new

registration requirements for different

categories of dangerous chemicals,

including for their manufacture, import,

export and storage (CW Briefing,

March 2010).

According to REACH24H Consulting, for

the first time non-Chinese companies as

well as Chinese companies will have to

register “dangerous” or “hazardous”

substances, and the government will issue

guidance on how to classify hazardous

chemicals according to their physico-

chemical, environmental hazard and

toxicological properties.

Another change, it says, is there will be a

broader definition of dangerous/hazardous

substances. Under the current regulation,

Chinese companies must register any of

the chemicals on the Dangerous Goods

List (GB 12268-2005), while those

classified as “highly toxic” must be

registered by Chinese and non-Chinese

companies. However the Dangerous

Goods List is being updated by SAWS,

and is expected to double in capacity.

According to Greenpeace China, for the

first time the term “dangerous chemicals”

will include environmental, as well as safety

hazards such as flammability and

corrosion, and greatly increases the

authority of the Ministry of Environmental

Protection (MEP). In particular, it says,

the MEP will receive the power to regulate

“dangerous chemicals for priority

environmental management”, which

will allow it to regulate existing, as well

as new chemicals.

This new authorisation, says the

environmental group, will allow the MEP

to produce a list of priority chemicals and

require companies producing or using

them to register them and report

information concerning “environmental

release and other aspects”. The MEP will

also be able to impose risk management

measures to such chemicals. How the

ministry will draw up the list of priority

chemicals and assess their environmental

hazards and risks is due to be specified

in implementing measures that the MEP

will promulgate later. The SAWS is also

expected to introduce a series of

implementing measures.

According to Regulatory Services

International, “the decree shows the

increasing level of attention which is being

paid to chemical legislation in China, and in

particular the prominence of penalties and

enforcement.”

Meanwhile, the MEP has finalised

membership of the expert committee

known as the Chemicals Environmental

Management Review Committee, that will

be responsible for the review of

applications for the notification of new

substances under the Measures for the

Environmental Management of New

Chemicals (CW Briefing, November 2010).

It will probably also be responsible for

reviewing existing chemicals after relevant

regulations come into place.

China introduces classification and labelling rulesAll companies will have to register “dangerous” or “hazardous” substances for the first time

25 March 2011



Regulations requiring consumer product

designers, manufacturers and importers

in California to carry out detailed studies

of whether alternatives exist to products

containing chemicals of concern, could

become law by the end of the year

following the publication of the proposed

regulations on 27 July by the state’s

Department of Toxic Substances

Control (DTSC).

The proposals contain a number of

significant changes compared to the draft

regulations issued by the department last

autumn (CW 24 May 2012 and CW Briefing

December 2011/January 2012):

» the chemicals of concern list has been

narrowed to about 1,200 chemicals

compiled from comparable recognised

existing lists;

» the idea of using a numerical “de

minimus level” to trigger the need for an

alternatives analysis has been replaced

by an “alternatives analysis threshold”.

This will be determined on a case-by-

case basis for each chemical of concern

in a “priority product”;

» the removal of a distinction between an

“assembled” and a “formulated product”;

» a revised definition of the term “a

technically and economically feasible

alternative” that eliminates cost

assessments for which reliable data

is not available;

» occupational health impacts are now

included in definitions of “adverse health

impacts” and “sensitive subpopulations”;

» a chemical’s ability to degrade or

metabolise into another chemical has

been incorporated into the regulations;

and

» the clarification that trade secret

protection cannot be claimed for hazard

trait information submissions.

The proposed regulations state that the

first list of priority products, for which the

DTSC will issue a work plan by January

2014, will contain no more than five

product-chemical combinations. Priority

products can be listed as such only if they

contain chemicals that meet certain hazard

traits and exposure criteria.

DTSC director, Debbie Raphael, called the

proposed set of regulations

“groundbreaking”. They “will be good not

only for the health of our consumers but for

our economy,” she said, insisting they had

been designed to “bring in the best

available science and reduce the likelihood

of regrettable substitutions”.

About three dozen businesses and

organisations have signed a letter urging

California Governor Edmund (Jerry) Brown,

Jr to support the DTSC in finalising the

regulations. While “not perfect”, the

regulations have the potential to help

California businesses capture the “growing

global market for green products and

services,” said the groups, which includ the

American Sustainable Business Alliance,

the environmentally responsible healthcare

network Health Care Without Harm and the

medical and public health group Physicians

for Social Responsibility.

The Green Chemistry Alliance (GCA), a

group of manufacturers, retailers, and trade

associations, said in a statement that its

review of the proposed regulations would

focus on impacts to California’s economy.

“It is our hope,” it said, “that this proposed

draft of the regulations reflects a

willingness on the part of regulators in

Governor Brown’s administration to achieve

California’s green chemistry goals without

endangering jobs or placing new burdens

on consumers”.

Comments on the proposed regulations

must be received by 11 September 2012,

the day after a public hearing on the

proposed regulations is due to be held in

Sacramento. DTSC says it expects the

regulation to be finalised by the end

of 2012.

California issues proposed Safer Consumer Products RegulationsList of chemicals of concern expected to be around 1,200 rather than 3,000

30 July 2012



Walmart, the world’s largest retailer,

has announced a major initiative to

tackle chemicals of concern in consumer

products. Starting with a list of ten

“priority” substances, the company

will work with suppliers to eliminate

the chemicals.

The list will not be published until Walmart

has discussed the chemical selection with

its suppliers. The sustainable chemistry in

consumables initiative targets substances

used in household cleaning products,

cosmetics and other personal care

products sold by both Walmart and its

subsidiary Sam’s Club, throughout the US.

The priority substances have been chosen,

based on their use in products, the

availability of viable alternatives, and which

will make the most impact, says the

company’s senior vice president for

sustainability, Andrea Thomas.

Under the policy, Walmart will also begin to

label its own brand cleaning products,

using US Environmental Protection Agency

(EPA) Design for Environment (DfE)

guidelines. From January 2015, the policy

will require suppliers to provide public

online ingredient disclosure for products in

the categories covered. Walmart will then

extend the disclosure requirement to

product labels but it “will take a while

to get there, and work through existing

packaging,” Ms Thomas explains.

Beginning in January 2018, any products

still containing “high priority” chemicals will

have to disclose these ingredients on

package labels.

Walmart will review the priority chemical

list regularly and consider extending it,

as well as applying DfE recommendations

to additional product categories. The

company will begin monitoring progress

on the reduction, restriction and

elimination of high priority substances

in January 2014, and report publicly

on this progress from January 2016.

Consumer and environmental health

advocates welcomed the initiative. The

Environmental Working Group calls the

policy “a sea change event on behalf

of public health and the environment.”

While Safer Chemicals, Healthy Families

describes the move as, “a meaningful

down payment on an enhanced chemicals

policy.” Campaign for Safe Cosmetics

co-founder, Stacy Malkan, calls it “a loud

and clear signal to companies that people

do not want to buy products made with

toxic chemicals.”

“No other company is requiring the all-

important, but often forgotten, second

step to truly transformational phase-outs:

putting a system in place that avoids

regrettable chemical substitutions. EDF

commends this aggressive new policy,”

says Environmental Defense Fund (EDF)

environmental health programme director,

Sarah Vogel.

Ms Thomas stresses that the policy has

been created to enable Walmart “to get

ahead of consumer concern” and “lead

in the option of green chemistry”. This is,

she says, “an opportunity to better serve

consumers”. The chemicals policy is part

of the company’s Sustainability Index that

currently involves 1,000 suppliers; a

number expected to increase to about

5,000 by the end of the year.

Walmart targets ten substances of concern in consumer productsNGOs welcome policy that focuses on green chemistry

13 September 2013



The revisions to Taiwan’s Toxic Chemical

Substances Control Act (TCSCA) were

promulgated by President Ma Ying-jeou

on 11 December, according to an

Environmental Protection Administration

statement, and will therefore take effect

in December 2014. The revisions were

approved by the Legislative Yuan on 22

November (CW 22 November 2013).

The changes allow the government to

“have effective control over manufactured

or imported chemical substances through

a chemical substances registration system

and by bolstering the regulation of Class 4

toxic chemical substances.”

The EPA said a number of implementation

regulations will have to be revised or

drafted and approved by 11 December

2014. These include:

» rules for the registration and regulation

of chemical substances;

» enforcement rules for the regulation

of toxic chemical substances;

» regulations for the review and

determination of Class 4 toxic chemical

substances;

» rules for the commissioning of the

examination of chemical substance

registration applications;

» regulations on the disclosure and

storage of substance safety data; and

» regulations for the setting of standards

for fees for application to the transport

of toxic chemicals and for the

management of toxic chemical

substance disaster emergency vehicles

(to be drafted jointly with the Ministry of

Transportation and Communications).

The EPA hopes that the implementation

of the revisions will more or less coincide

with the official formation of the new

Ministry of Natural Resources and

Environmental Protection (MNREP).

The ministry will include a chemicals

and pollution control agency (CW 28

November 2013).

The EPA said it is now actively planning

for the formulation of drafts for such

regulations and would hold public hearings

and seminars on the drafts from

September 2014.

This article has been revised since it was

first published on 12 December to say the

law was promulgated on 11 December

not 13 December.

Taiwan adopts revised TCSCAPublic hearings on implementation regulations expected next autumn

12 December 2013

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The National Assembly of South Korea

has adopted K-REACH, which will

require substances to be registered and

evaluated from 1 January 2015.

The Act passed through the National

Assembly’s Legislation Committee, and

then the plenary session of the National

Assembly, on Tuesday of this week. The

final version is understood to be little

changed from the version adopted by the

Environment and Labour Committee last

week (CW 25 April 2013).

The obligation to report risk information on

substances to the Ministry of Environment

only applies to manufacturers and

importers. The proposal adopted by the

Environment and Labour Committee had

included substance users under this

obligation.

Requirements on communication on safe

use down the supply chain have been

modified, with the plenary adopting

comments from the Legislative Committee.

It suggested removing specific

requirements on communicating

registered tonnage, substance properties,

registered uses and safe use information in

favour of more generic language saying

manufacturers, importers and companies

that sell substances and mixtures in the

supply chain shall provide information on

safe use to downstream users as

requested in order to fulfil the registration.

A 1tonne/year overall use threshold, rather

than 0.1% product specific weight ratio,

has been introduced for the reporting of

hazardous chemicals in articles. Articles

that do not release hazardous chemicals

during use are exempt.

The obligation to report annually has been

dropped for substances manufactured in

volumes of less than 10tonne/year that are

solely exported.

South Korea adopts K-REACHLegislature makes few changes to latest version

The OECD, the US EPA and the

European Commission’s Joint Research

Centre have jointly launched a web tool

called the Adverse Outcome Pathway

Knowledge Base (AOPKB), which aims

to bring together information on how

chemicals can cause adverse effects

(CW 4 June 2014).

The first module to be launched is an AOP

wiki, through which knowledge can be

shared and commented on. The OECD

invites researchers from academia,

government agencies and the chemical

industry to use it. It also strongly

encourages people to post comment and

content. “It is through such ‘crowdsourcing’

that the AOPKB will ultimately evolve,”

says an OECD statement.

AOPs in the wiki are represented by

interlinked articles and tables, describing

molecular initiating events, intermediate

events and adverse outcomes. Pages on

key event relationships highlight

associations between different events and

adverse outcomes. Those interested in

gaining access to insert their own AOPs

need to make a project proposal to the

development programme.

“We currently have eight AOPs available

for comments,” says Joop de Knecht from

the OECD’s Environment Directorate. “The

rest [31] are still under construction, giving

developers the opportunity to further

develop them.” Although the wiki is

currently “somewhat limited”, the OECD

has opted for early public release in the

hope of engaging as many potential AOP

developers and contributors as possible,

the organisation says.

In future, the knowledge base will include

an “effectopedia” to show AOPs in a

graphical way, together with an “AOP

Xplorer” to help visualise them. It will also

contain an intermediate effects database,

which will aim to put AOP components

in a regulatory context.”

The AOPs ready for comment are:

» alkylation of DNA in male pre-meiotic

germ cells, leading to heritable

mutations;

» AHR1 activation, leading to

developmental abnormalities and

embryo lethality;

» androgen receptor agonism, leading

to reproductive dysfunction;

» aromatase inhibition, leading


» cholestatic liver injury, induced by

inhibition of the bile salt export pump;

» oestrogen receptor antagonism, leading


» protein alkylation leading to liver fibrosis;

and

» sustained AhR activation, leading to

rodent liver tumours.

OECD and US EPA launch AOP wikiReady for perusal and comments

2 May 2013

25 September 2014



Chemistry runs through all SDGs, says Unep head

Commenting on the UN General

Assembly adoption of the 2030 Agenda

for Sustainable Development, along with

a set of 17 Sustainable Development

Goals (SDGs), Achim Steiner, executive

director of the UN Environment

Programme said: “The SDGs are

quantitatively and substantively a step

ahead from what we have had before

anytime in the past 30 years.”

Speaking at the International Conference

on Chemicals Management (ICCM4),

Mr Steiner said chemical products play

a direct role in several of the SDGs.

These include clean water, good health

and responsible consumption and

production, however “chemistry occurs

in them all.”

He added that in the past sustainable

development has been dealt with through

“trade offs” between industrial growth,

and environment and human health.

Often though these have been unjust,

resulting in different groups benefiting

while others fall victim, he said. “If the

world is going to sustain ten billion people

… we need sustainable chemistry to ensure

our footprint is reasonable.”

He added there is a need to move away

from dealing with chemicals on the market,

one by one. “We have to go downstream

and think how we redefine the criteria we

use to support sustainable chemistry and

reconfigure the way governments then

deploy them.”

He noted that the International Sustainable

Chemistry Collaborative Centre (ISC3) –

recently announced by Germany (CW 29

September 2015) – should help in this

process of moving to more intelligent

and empowering approaches to

sustainable chemistry.

1 October 2015

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US President Barack Obama has signed

into law a bill to modernise the Toxic

Substances Control Act (TSCA).

The Frank R Lautenberg Chemical Safety

for the 21st Century Act updates the US’s

chemicals management law for the first

time in 40 years, and reflects years of

congressional effort to get the law

reformed.

The measure cleared Congress in a Senate

voice vote on 7 June. The final bill came

after months of negotiation between

Senate and House leaders on both sides

of the aisle, who sought to reconcile

bills passed by the respective chambers

last year.

“This is a good law, it is an important law,”

said President Obama, at its signing. “For

the first time in our history, we’ll actually

be able to regulate chemicals effectively.”

Senator Tom Udall (D–New Mexico) said

the challenge will now be to “ensure the

new programme is a success”. As the

lead Democrat on the Appropriations

subcommittee that oversees the EPA’s

budget, he said he was “putting the

EPA and the industry on notice:

I will be watching”.

The law’s enactment now sets into motion

a series of “very ambitious deadlines”

to implement the measure.

Implementation begins

In just the first year, for example, the EPA

must complete several formal rulemakings,

including to establish processes for

prioritisation, risk evaluation and “resetting”

the inventory of chemicals in commerce.

Meanwhile, the Lautenberg Act requires

the agency to work on risk evaluations for

at least ten substances, within the next six

months. Additional guidance documents,

policies and activities prescribed by the

law must also be completed.

EPA’s leader Gina McCarthy said the law is

a “huge win for public health”, and that the

agency is “eager to get to work”.

Administration’s priorities

The President’s signature was all but

assured, given the administration’s public

endorsement of the bill shortly before the

House’s vote on the measure.

A 23 May Statement of Administration

Policy said the bill “is a clear improvement

over the current TSCA and represents a

historic advancement for both chemical

safety and environmental law”. It had urged

“quick action on this landmark reform”.

The statement said that “while not perfect,

the bill meets the high goals set by the

administration for meaningful reform,”

in order to address “flaws” under existing

TSCA that have limited the EPA’s ability

to provide sufficient protections against

chemical risks.

Ms McCarthy echoed those sentiments,

saying the original law “fell far short of

giving EPA the authority we needed

to get the job done”.

“The updated law gives EPA the authorities

we need to protect American families from

the health effects of dangerous chemicals,”

she added.

These include such changes as:

» requiring the EPA to evaluate new and

existing chemicals against a risk-based

safety standard, with explicit

consideration for vulnerable populations;

» empowering the agency to require the

development of chemical information

to support risk assessment;

» establishing “clear and enforceable

deadlines” for prioritisation and any

necessary risk management;

» increasing transparency of chemical

information by limiting “unwarranted

claims of confidentiality”; and

» providing more funding for the EPA

to carry out its new responsibilities.

TSCA reform signed into lawPresident’s signature sets implementation in motion

22 June 2016

TSCACoverage highlights

chemicalwatch.com/tsca-highlights


Work on Brazil’s planned industrial

chemicals regulation is moving forward

again after Conasq, the country’s

National Chemical Safety Agency, met

on 6-7 July to review responses to last

year’s consultation on a draft policy.

This sets out provisions covering the

registration, evaluation and control of

chemicals, as well as plans to establish a

national chemicals register and technical

committees for selecting substances and

imposing regulatory measures.

At the meeting, Conasq divided comments

submitted in the consultation into four

categories: a matter of law; a matter of

regulations (secondary level law); out of

scope; and doubts and other issues.

The comments touched on a wide range

of subjects, including:

» the need for the proposed regulation

to be more far-reaching and take in,

among other things, nanomaterials,

pharmaceuticals and veterinary

products;

» the use of an only representative

legal entity;

» the nature and protection of confidential

business information (CBI);

» the need for a formalised annual

notifying period;

» lowering the threshold for reporting

a substance to 100kg/year (from one

tonne/year);

» the establishment of an appeals board

to allow decisions to be challenged; and

» a ban on animal testing.

The meeting also discussed lead in paints,

mercury and raising awareness on

chemical safety.

The agency is scheduled to meet again on

12-14 September. However, it may meet

on 16 August to finalise the screening

process and discuss the contributions

classified as a ‘matter of law’.

Next steps

Conasq is currently evaluating and

providing public justifications for its

acceptance or rejection of all of the

responses. When this process is complete,

it will approve the final text of an amended

draft law. The environment, health, labour

and industry ministers will then review it

and put their names to it before sending

it to Congress.

Here it must be submitted to one or more

parliamentary commissions, and to the

Chamber of Deputies and the Senate,

before being sent to the President of

the Republic.

Conasq says it has been “holding regular

and extraordinary meetings to accomplish

these tasks by the end of 2017”.

The consultation document says the policy

is needed because despite Brazil having

established regulatory schemes for

specific types of chemical products, such

as pesticides, sanitisers, food additives,

medicines and cosmetics, a large number

of substances, especially those used in

industrial processes, are not covered.

It estimates that 10-15,000 substances

are placed on the national market and

used “without any kind of monitoring

or systematic control of public power –

a gap that this draft law aims to remedy”.

Brazil moves forward on industrial chemicals regulationConasq evaluating consultation responses

Thank you for your support over the last decade, and we look forward to providing you with the facts and perspectives you need to achieve safer chemicals in products for the next 10 years.

22 July 2017

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