global emerging regulations (ger) network of experts · global emerging regulations (ger) network...

Global Emerging Regulations (GER)Network of Experts

2017 Annual Report

January 2018

1

This report covers those non-EU countries where regulatory reform has occurred or continuedduring 2017. Those Cefic Members who only wish to refer to selected regions may click on thelist in the table of contents for immediate access.

In case members would like to have information on other countries, Cefic should becontacted for information (Maria Ruiz-Cuevas [[email protected]])

Disclaimer: The information contained in this document is for Cefic’s members only and furtherdistribution beyond that is not allowed. Whilst the information is provided in utmost good faith andhas been based on the best information currently available, it is to be relied upon at the user’sown risk. No representations or warranties are made with regard to its completeness or accuracyand no liability will be accepted by Cefic nor any company participating in Cefic for damages ofany nature whatsoever resulting from the use of or reliance on the information.

GER 2017Annual Report

2

TABLE OF CONTENTS

MAINLAND CHINA (PEOPLE’S REPUBLIC) 3

SOUTH KOREA 3

JAPAN 6

TAIWAN 6

THAILAND 7

INDONESIA 8

INDIA 9

PHILIPPINES 10

VIETNAM 10

LAOS 10

AUSTRALIA 11

NEW ZEALAND 13

EURASIAN ECONOMIC UNION (EAEU) 14

SWITZERLAND 14

TURKEY 15

UKRAINE 17

SOUTH AFRICA 17

US 18

BRAZIL 20

COLOMBIA 21


3

MAINLAND CHINA (People’s Republic)

The data requirements part of the Order 7 technical guidance has been updated and published,but not the full document. The new data requirements came into force on15th October in 2017.

Changes include:- Only relevant exposure route (primarily the oral route) is now required for acute toxicity at

level 1.- 28 day repeat dose study is required only starting at level 2.- 90 day repeat dose study is required only starting at level 3.- Full toxicokinetics is no longer required for level 2 and above.- New waiving criteria for chronic toxicity and carcinogenicity introduced for level 4.

The outcome of Order 7 compliance checks by local Authorities in the Shanghai area have notbeen made publically available, or to MEP-SCC.The CEFIC membership is reminded that a comprehensive revision of Order 7 is planned, whichincludes comparison with other international regulatory schemes (e.g. REACH, revised TSCA,South Korea, Canada, etc.), with the aim of more effectively managing new chemical substancesin China. This is probably one of the reasons why the full guidance document has not beenupdated.The Chinese Ministry of Environmental Protection (MEP is drafting a new regulation calledRegulations on Environmental Management of Chemicals to cover both new chemical substancemanagement and existing chemicals management. It is anticipated that a new legal instrumentwill be used with “increased status” (e.g. regulation by State Council or law by National People’sCommittee).On 29th December 2017, MEP published the Catalogue of Priority Chemicals (1st Batch) andoutlined the risk control measures on these chemicals.On the same date MEP also published the Inventory of Severely Restricted Toxic Chemicals(2018) together with the instructions on the “Notification for Customs Clearance forImporting/Exporting Toxic Chemicals”.

SOUTH KOREA

As previously reported, the Korea government has announced the measures they would take forchemicals management including registrations for all existing chemicals. This was announced atthe Cabinet Council of Government on November 29 2016. Following the humidifier disinfectantand other chemical accidents, the Office of Government Policy Co-ordination had consulted andworked to find relevant measures to manage chemical products with relevant ministriesincluding MoE, MoEL, MoTIE, KFDA. So that its membership is fully aware of the proposedchange, Cefic believes that it is worthwhile re-iterating the following taken from a translatedversion of MoE Notice 2016-869, dated 28th December 2016:A. Abolishing annual reporting and introducing a pre-registration scheme (amendment of Article8): Annual reporting required under ARECs and statistical survey under Chemicals Control Act(CCA) is redundant.B. Abolishing designation of PECs (Priority Existing Chemicals) (deletion of Article 9) andintroducing a grace period for registration of all existing chemicals (amendment of Article 10).


4

The current PEC designation system among exiting chemicals is somewhat inappropriate forthe long-term management of existing chemicals and thus a grace period is adopted forregistration of all existing chemicals manufactured or imported in quantities of 1 ton or above.C. Improving designation and control of chemicals subject to authorization (amendment ofArticle 25). Exempt uses are designated for chemicals subject to authorization andmanufacturing, importing and using such chemicals for other uses is banned withoutauthorisation.D. Extending information provision of chemicals (amendment of Article 29). In addition,information is required to be provided to downstream users (customers) for hazardoussubstance and the mixture containing them.E. Amendment of Article 32: Notification of risk concerned substances (CMR and PBT) inproducts are required in addition to hazardous substances.F. Penalties (Article 37, Paragraph 2). In case manufacturers or importers of unregisteredchemicals cause harm to human health or the environment, penalties equivalent to a certainportion of the revenue of those chemicals is imposed.The Korea Ministry of Environment has confirmed the K-REACH deadlines for registration:The first set of Priority Existing Chemicals need to be registered in accordance with the originalK-REACH legislation i.e. prior to the amendment. This will involve 510 substances, by June 2018.The current draft amendment comes into force directly afterwards, requiring all existing chemicalsubstances above 1 ton of annual production or import are to be registered as follows:- >= 1000 ton volume band and carcinogens: by 2021 (for approx. 1,100 subs.)- 100 ~ 1000 ton volume band: by 2024 (for approx. 1,100 subs)- 10 ~ 100 ton volume band: by 2027 (for approx. 2,000 subs)- 1~10 ton volume band: by 2030 (for approx. 2,300 subs)The amendment also introduces a pre-notification system for existing chemical substances. Pre-notification is due in 2019, the exact date is not yet confirmed.It is understood that the authorities are attempting to ensure there is alignment of K-REACHwith the new TSCA and EU REACH. Data access and mutual recognition are being considered.Cost sharing concepts and the procedures on study reports however need to be formallydeveloped.It should be noted that English language reports are acceptable but summaries have to be inthe local language.For biocides, it is recognised that there is duplication in K-REACH and the biocide regulation.Additional requirements for biocides will be implemented by the “Act on Safety Management ofHousehold Chemical Products and Biocides”. The Act will come into force on Jan 1, 2019.One major problem that the Cefic membership should be aware of is that under the formerTCCA, substances <100 kgs/year were exempted from notification and therefore they werenever inventory listed. Consequently they have to be registered under the current K-REACH asnew substances (simplified <100kg). For this, NIER is asking for registration including data intight timeframes. However it was announced that the situation could be made easier in thefuture as it is expected that by 1st June 2018 the system for <100kg chemicals will be via anotification with limited data i.e. not a registration. In the interim, registration and providing dataare not a serious concern, but testing (Ames and Acute Toxicity) is causing significant problems,with respect to timing.Two important meetings have recently taken place:On November 10 the European Chamber of commerce organised a meeting attended by Ceficand Korea’s MoE.Information and explanations were shared to achieve mutual understanding. Enforcement as ofJuly 2018 will remain; document submission must be done within the deadline on the IT systemeven if the data is incomplete. The registration deadline cannot be extended.Regulatory development:


5

On November 15, 2017, Korea’s National Institute of Environmental Research (NIER) proposedNIER Public Notice No. 2017-401, amending the regulation on risk assessments for riskconcerned products under K-REACH.The objectives of this amendment are as follows:•Add five products to the list of risk concerned products. These include windshield washer fluidsfor automobiles, candles, dehumidifying agents, engine antifreeze coolants and crack filler;•Provide the exposure factors of newly designated risk concerned products; and•Revise the exposure factors of the existing six risk concerned products, including cleaningagents, adhesives, coating agents, synthetic detergents, bleaching agents and fabric softener.The Toxic Chemical Substance List (TCSL), Hazard Evaluation Results under K-REACH andthe GHS Classification List are fairly dynamic; seeing almost monthly updates. The ExistingChemical Substances Inventory is also sometimes amended.Concern remains about polymer registrations, as polymers will not be exempt generally, as thehumidifier incident substance was a polymer.

The following scenario on polymers could be useful for the Cefic Membership:1. If company “X” had exempted a polymer “A” under TCCA, under the draft

amendment of K-REACH, company “X” needs to make a notification - even if thepolymer still meets with K-REACH exemption criteria, or to register if the polymerdoes not meet with K-REACH exemption criteria.

2. If company “Y” had received the exemption certificate from company “X” andimported the polymer prior to an enforcement of K-REACH, under the draftamendment of K-REACH, company “Y” needs to make a notification - even if thepolymer still meets with K-REACH exemption criteria, or to register if the polymerdoes not meet with K-REACH exemption criteria.

3. If company “Z” had received the exemption certificate from the company “X” butNOT imported the substance prior to an enforcement of K-REACH, if the polymermeets with K-REACH exemption criteria company “Z” should apply for anexemption under K-REACH prior to an importation. If the polymer does not meetwith K-REACH exemption criteria, the company “Z” should register the polymerwithin the grace period until Dec-31-2017.

Non inventory listed polymers for which all the monomers are listed on the inventory were notexempt under TCCA and are not exempt under K-REACH. These polymers are subject toeither register or exempt under K-REACH.It should be noted that this information is based on the current draft amendment and so may ormay not change in a final amendment. Also the MoE’s amendment proposal has not yetapproved by the National Assembly. However MoE still hopes to be approved and promulgatedby the end of this year, and then draft amendments of relevant subordinate enforcementordinance and rule can be announced in early next year for public consultation.For Case No 3 above, this has already been in place as a transitional measure from formerTCCA under current K-REACH. But this transitional measure will not be valid under the revisedK-REACH as the grace period ends at the end of this year.


6

JAPAN

On 7 March 2017, Japan’s Ministry of Economy, Trade, and Industry (METI) announced that thecabinet will submit a proposal to amend the Chemical Safety and Control Law (CSCL) to theDiet (Japan’s parliament).The amendment is expected to cover the following 4 items:i. Low volume notifications for <1MT and <10MT are to change the limit from the total quantityplaced on the Japanese market per annum to a total environmental release per annum, usingemission factors established for various uses. This could lead for example under the SmallQuantity Exemption category to each company being able to manufacture or import up to1MT/annum as long as the total emissions do not exceed 1MT for the whole of Japan.Previously the 1MT per annum had to be shared when two or more companies applied for thesame substance.ii. A new category of specified chemical substances that do not currently fit into a current classcould be implemented. The chemicals in question are those that are deemed to be highlyhazardous based on exposure and PNEC. They will most likely be subject to risk assessmentand restrictions.iii. It is also understood that the authorities are considering relaxing their demands on certainenvironmental studies. It could be that in the future an OECD 301F study for biodegradationwould be acceptable whereas the 301C is currently required. There may also be somerelaxation in requirements for identifying all degradation metabolites above 1% and perhapshaving to test these substances as well as the new substance being introduced. For the fishaccumulation study, there could be amended methodology concerning the feeding techniquesfor poorly soluble substances. They are considering introducing a single concentration levelconcept for establishing the BCF rather than two concentration levels.iv. For polymers, it is thought that the authorities may extend the 98% existing exemption rule(when the non-included monomers in a listed polymer are themselves inventory listed) to 90%.This would appear to allow for multiple occurrences of monomer/reactants present below 2%being covered by an existing polymer listing. Other more minor changes to the Polymer flowscheme for notifications are also under consideration.Assuming these proposals are adopted, some of the amendments are expected to be finalisedand published in early 2018, coming into force for 1st April 2018 whereas others may be later2018/early 2019. The situation will be critically monitored and reported during 2018.During the yea, the inter-ministerial committee (MHLW, METI and MoE) announced proposalsto add Decabromodiphenyl ether (decaBDE) and short-chain chlorinated paraffins (SCCP) tothe Class I Specified Chemical Substances list. This would implement a complete ban on theirmanufacture, import and use within Japan. Products containing these substances would also bebanned from import to Japan in future.

TAIWAN

Taiwan's cabinet has approved a draft set of revisions to the Toxic Chemical SubstanceControl Act, for submission to the national legislature

The Executive Yuan approved the bill in a regular weekly meeting on 9 November 2017. Thename of the law has changed to the Toxic and Chemical Substances of Concern Control Act.


7

The change was driven by the new category of 'chemical substances of concern' added to Classfour toxic chemical substances.The original Act had 44 articles grouped into five chapters. The new draft has 72 articles in eightchapters. There are also additional sections on the evaluation, prevention and regulation ofchemical substances of concern, the registration and reporting of chemical substances andauditing, testing and finance.The first draft of the Priority Existing Chemicals (PECs) list is now available. It contains 122substances; the final list is expected to be adopted at the end of the year. Two further batchesare expected to be issued in the future, making the total number of substances about 450.Standard registration shall be done within 3 years for annual volume above 1 ton. Someendpoints could be omitted if adequate information is available in the public domain. It ispossible to choose between Joint or Individual registration. Periodic reporting on chemicalvolumes is expected to be introduced.

Taiwan's Environmental Protection Administration (EPA) is consulting on changes tonew and existing chemical registrations

The new draft is harmonizing registration types and data requirements between the ToxicChemical Substances Control Act (TCSCA) and the Occupational Safety and Health Act(OSHA). It is also setting a trigger for obligatory Phase I registration. For an existing chemicalsubstance M/I in annual volume of 100kg or more, the phase one registration must be madewithin 6 months of first time manufacturing, or import.A voluntary phase 1 registration may be made for existing chemicals manufacture or imported inannual volume of less than 100kg.The draft enforces standard registration for chemicals in any volume that are found to be"carcinogenic, mutagenic, or toxic to reproduction."A registration form will be required for companies using new chemicals in research anddevelopment.Under the new Article 22, the period for confidentiality protection is standardized to five years forboth Phase1 registered existing chemical substances and standard registration and two yearsfor simplified and small volume registrations. The maximum period for CBI protection will be 15years, unless the substances are transferred to the inventory, in which case it will be 10 years.Annual reporting on new and existing substances will be required.New registrants, who have objections to the results of the reviews, will be able to submit writtenappeals within 30 days under the newly added draft Article 31.

THAILAND

The Cefic Membership is alerted to the following issues:

Thailand requires a chemical product notification under list 5.6 to the DIW. This is a one-time notification for manufactured/imported hazardous product greater than 1ton/annum, if they are not already regulated by DIW. Notification of volumes < 1ton/annum is voluntary. Some products may have to be registered twice. Once with DIW(for industrial use) and also with FDA (e.g. cleaning product). The FDA registration mustbe renewed every 6 years. In addition, a separate import licence is required, which mustbe renewed every 3 years.


8

The Authorities are still working on the draft inventory. Industry should makenominations on the first import/manufacture. It is expected that the inventory will bereleased next year. A decision on what happens next is still unknown, but it isunderstood other established schemes are being considered as models

List 5.6 will be used to build the existing substances inventory from submission of‘hazardous’ chemicals. Hazardous however means everything, the authority will thendecide what is hazardous or not.

To ensure a successful notification, it requires the disclosure of the full chemicalformulation to the authority. For companies not willing to share the full formulation withthe importer it is possible to submit confidential business information directly to theauthority. For CBI, companies need to proceed with the online consultation requestbefore initiating the CBI claim step. This requires a registration number from the onlinesystem to give DIW together with the confidential information. However, since the end of2016 it has been mentioned that submissions under a CBI have not been processed.

The Authorities are still working on the draft inventory. Industry should make nominationson the first import/manufacture. It is expected that the inventory will be released early nextyear. A decision on what happens next is still unknown, but it is understood otherestablished schemes are being considered as models.

Developments will be closely monitored.

INDONESIA

MoEF No 36 Year 2017 Regulations on Registration and Notification of Hazardous andToxic SubstancesThe Ministry of Environment and Forestry (MoEF) released Regulation 36/2017 that has been inforce since 8 June 2017 and now repeals and replaces Regulation 2/2010 to regulate theregistration and notification of hazardous and toxic substances.Regulation number 36/2017 covers:-B3 (Bahan Berbahaya dan Beracun / Hazardous and Toxic substance) registration-B3 Notification.With regards to the registration for imported and locally produced products, the submission isachieved through an online system. Documents required include business license, warehouseand packaging pictures, import permit, shipping document and notification approval from countryof origin, SDS and certificate of analysis. Based on the application, the authority will performadministration and technical verifications. There is a maximum 2-day time line from the date ofapplication for verification and issue of the registration letter.For the notification, this only applies to imported/exported B3 or B3 chemicals which are importedto Indonesia for the first time. There is a 30-day time line from the date of application forverification. Regulation 36/2017 will pose various challenges for industry that will need to beaddressed.Indeed there are some concerns from associations that this regulation will cause high economicimpact, increase lead time and long bureaucratic process.The Regulation covers the technical guidance for companies with respect to the process forregistration and notification the regulated substances (how to do the process). This technicalguidance also covers timelines, the documentation required to process the registration, etc.

Regulation Number 74 (Year 2001)


9

The Indonesian authority is currently revising Regulation Number 74 (Year 2001) concerning theManagement of Hazardous and Toxic Substances. In the new regulation, the number ofregulated substances (B3 chemicals) will be expanded and will include mixture products, whichare not covered in the list. Regulation 74 Year 2001 (and the updated version) covers themanagement of Hazardous and Toxic Substances for example classification of the hazardoussubstances, SDS requirement, packaging requirement, and list of regulated substances. ThisRegulation also covers the obligation of registration and notification but not the technicalguidance.

The following points should be noted:

1. Products that are not listed in Regulation 74 list need to be categorized or classified as:can be used, prohibited, or require notification.2. The categorization would be organized by a B3 (Hazardous and Toxic substances)Commission, which needs to be formed through President decree. As the B3 Commission hasnot been established yet, the registration for mixture products that are not listed in Regulation74/2001 Year is not required until this happens.3. Registration numbers for mixture products are no longer applied and such products can beimported without registration (including products for which the registration number hasexpired). Mixtures which contain forbidden substances will remain prohibited and not allowedto be imported or used in Indonesia.

INDIA

India ratified the Stockholm Convention on POPs on the 13th Jan 2006.The Government of India (Ministry of Environment, Forest and Climate change) has issued adraft notification dated 29th August 2017 to regulate the manufacture, trade, use, import andexport of seven chemicals which have been listed as Persistent Organic Pollutants (POPs) inthe Annex 'A' of the Stockholm Convention. These are- Chlordecone;- Hexabromobiphenyl;- Hexabromodiphenyl ether and heptabromodiphenyl ether (commercial octa-BDE);- Tetrabromodiphenyl ether and pentabromodiphenyl ether (commercial penta-BDE);- Pentachlorobenzene;- Hexabromocyclododecane and- Hexachlorobutadine

The India's (MoEF & CC) Ministry Environment, Forests and Climate Change is working on aNational Action Plan (NAPC). Industry opinion is being sought and it is expected to have a draftearly 2018. This NAPC covers the review of current legislation, registration of chemicals, phaseout of certain chemicals.NAPC is different from the draft National Chemical Policy (NCP) developed by Ministry ofChemicals and Fertilisers (MoC&F). On the NCP there have been no further developments withregards to the chemical policy, and inventory.A presentation around Responsible Care is available if on request.


10

PHILIPPINES

Small Quantity Import Petition:Cefic Members are reminded that SQIs may only be renewed 3 times. Previously, renewalswere required every year but without limitation for number of times renewed. The newprocedure impacts low volume chemicals and potentially valuable high-tech products ormaterials and due to the required detailed compositional disclosures gives rise to CBI concerns.

Polymer Notification and/or exemption:A new draft policy on polymers would remove the top 2 monomer exemption rule. A Polymer ofLow Concern (PLC) may be exempt if the “2% rule” applies or if all monomers are listed onPICCS. However, if a monomer is on the Priority Chemical List, that polymer is not eligible forexemption. The status or timing of the draft policy is not clear, but it seems the provisions arealready being enforced. Companies have experienced rejections for polymer exemptions madefor polymers containing PICCS listed PCL monomers. However, DENR has no clear way to notifya polymer without a full data set generally associated with a chemical notification.A CEFIC position paper has been submitted covering polymer policy; SQI; compositionaldisclosures; criteria for Abbreviated PMPIN; PMPIN review periods and 3rd party submissions.

Philippine EMB Clarified Confusions on Chemical Permits.On Dec 7th 2017, the Environmental Management Bureau (EMB) of the Philippines issued adocument, clarifying some confusions that enterprises encountered when trying to apply forpermits for their chemicals. This is available on request.

VIETNAM

The compilation of an existing chemicals inventory continues with the local version expected tobe finalized during Q1/2 2018. The third draft is expected later with some 16,000 chemicals onthe list.Decree No. 113/2017/ND-CP (Law on Chemicals) has been published. This includes 5annexes of chemicals requiring control measures.

LAOS

As reported in Q2, an English language version on the Laos Law on chemicals has beensourced and circulated. It is understood that there is an Indo-China cooperation with annualmeetings on chemical management supported by the Swedish KEMI. This includes Thailand,Vietnam, Laos, Cambodia and possibly Myanmar. The Laos outline looks very similar to theVietnam Chemical Law i.e. high level and details to be filled in later.


11

According to the translated draft, the law shall become effective within 120 days from the datethat the President of the Lao PDR issues a Presidential Decree promulgating the law and 15days after it has been posted in the Official Gazette. The situation continues to be closelymonitored but no further information has been sourced since Q2.

AUSTRALIA

The Australian Government is reforming the National Industrial Chemicals Notification andAssessment Scheme (NICNAS) aand the fifth NICNAS consultation was released. Ceficprovided comments on the consultation in line with the stated deadline.Detailed information is available on request, a summary of the consultation paper featuresbelow:Aim:To provide stakeholder opportunity to feedback on matters to be included in the delegatedlegislation. (Other elements of the reforms, which will not be part of the delegated legislation areto be consulted on later this year which includes evaluations initiated by AICIS and how the newCBI protection will work).Overview of content:Details for unlisted chemicals when determined as being exempt reported or assessed. Detailsare provided on the hazard and exposure criteria for categorisation. Human health andenvironmental risks must be considered.Human Health Exposure bands – Key changes since consultation paper 3

Change to terminology – end uses that will and will not result in “intentional humanexposure” to recognise it is not only cosmetics which are associated with intentionalexposure to the public

Low volume threshold (<10kg/annum) added R & D criteria have been refined

Human Health Hazard bands – Key changes since consultation paper 3 Nanomaterials removed and how to deal with these materials is covered in part 7 of

consultation paper 5 Addition of some non-GHS hazard statements applicable in Australia Physical hazards omitted from band B Categorisation outcomes for polymers and chemicals with sequences of fully fluorinated

carbon atoms have been refined.

Environment Exposure bands – Key changes since consultation paper 3 Change in terminology to refer to “treated release volume” Addition of a low volume threshold band The “irreversible bound within an inert matrix” criterion in exposure band 5 was removed

Environment Hazard bands – Key changes since consultation paper 3 Nanomaterials removed and how to deal with these materials is covered in part 7 of

consultation paper 5 Synthetic greenhouse gas chemical added to hazard band E Hazard band B refined criteria for polymers and inorganic chemicals Refined and clarified the categorisation outcomes for polymer and chemicals containing

sequences of full fluorinated carbon atoms


12

Explicit details are given on the international assessments accepted for introduction of potentiallyhigher risk chemicals as reported, which would otherwise be categorised as assessed.Details on the hazard information requirements are given in part 5. This includes details of optionson how to demonstrate a chemical is not hazardous for human health per exposure band andthose required to categorise a chemical for the environment as assessed or not (or exempted).The supporting material(https://www.nicnas.gov.au/__data/assets/pdf_file/0011/50060/CP5_supporting-material-FINAL-01062017.pdf) gives further details on the specifics of information requirements to categorisechemicals for introductions.Part 6 provides details on additional requirements for specified chemical introductions where it is

deemed that the minimum information requirements will not be enough to determine the indicativerisk.Nanomaterials as mentioned above are discussed in part 7 as to how unlisted chemical will beintroduced at the nanoscale. Nano-scale chemicals will have their own hazard and exposure bandcriteria for categorisation, they have moved away from the option that all nanomaterials beinglooked at as assessed however the thresholds are low for not being assessed;∙ Exempted if introduced at ≤10 kg/annum for the purposes of research and development, or as

a contained import/export introduction∙ Reported if introduced at >10 kg/annum and ≤100 kg/annum for the purposes of research and

development∙ Assessed in all other circumstances.

The categorisation criteria are discussed in the paper and looks at the following elements asopposed to having a static definition of nanomaterial;∙ size and distribution∙ intentionally manufactured∙ size-dependent properties∙ aggregates and agglomerates∙ solubility/dissolution rateCommercial evaluation authorisationBan on the use of new animal test data for cosmetic ingredientsAmendment to the 2% rule for polymers, additional criteria to use the rule;

- any such additional monomers and reactants that constitute no greater than 2% weight of theunlisted polymer must not be known or suspected of being:

- persistent, bioaccumulative and toxic (PBT) according to the national PBT criteria; or- chemicals containing a sequence of one or more fully fluorinated carbon atoms; or- chemicals that contain mercury, lead, cadmium or arsenic

Key changes to the PLC criteria are detailed including; criterion relating to fluorinated polymers,stability criterion, reactive function groups and polyesters.

The Industrial Chemicals Bill is now with the Australian Parliament to be debated by the Senate.The outcome of several consultation papers are being progressed through senate. At presentthere has been no communication on a change to the implementation date of the reforms(planned as July 2018).


13

NEW ZEALAND

EPA notices are the new tool to set out the rules staying under the HSNO regime and aredesigned to make it easier to comply with the HSNO ACT containing almost all of the rules youneed to know about a particular subject in one place.The below offers an update on the status of the notices issues thus far;

Notices issued which come in to act 1st December 2017

There are eight new notices which will come in to force from 1st December 2017, they are; Minimum Degrees of Hazard Notice The Classification Notice The Labelling Notice The Safety Data Sheets Notice The Packaging Notice The Disposal Notice The Hazardous Property Controls Notice The Forms and Information Notice

Those highlighted are those that could potentially have the greatest impact given they containthe greatest changes from previous regulation, as such the New Zealand EPA has createdsummary to documents to illustrate “what’s changing” on these topics, available from theirwebsite (https://www.epa.govt.nz/industry-areas/hazardous-substances/rules-for-hazardous-substances/epa-notices-for-hazardous-substances/)

Individual approvalsGenerally, substances approved before 1 December 2017 do not need to comply with the newNotices until their approvals have been legally reissued. Once reissued, you will have a timeperiod of between two and four years to comply with the new requirements in the Labelling, SafetyData Sheet and Packaging Notices.New hazardous substances approved after 1 December 2017 will need to comply with allNotices immediately.

Group StandardsHazardous substances allowed under an existing group standard will have four years to complywith the new Labelling, Safety Data Sheet and Packaging Notices. Therefore, these substanceswill need to be fully compliant by 1 December 2021.

Notices already in force Hazardous Substances (Importers and Manufacturers Information) Notice 2015 Hazardous Substances (Enforcement Officer Qualifications) Notice 2015

Revised Group StandardsAll group standards have been reissued to take into account the new EPA Notices.The updated group standards will have the same:

name (with one exception), but updated year approval number classifications currently covered by the group standard.


14

More information can be found: https://www.epa.govt.nz/industry-areas/hazardous-substances/group-standards/2017-group-standards/Hazardous substances covered under reissued group standards will have four years to complywith the Labelling, Safety Data Sheet and Packaging Notices.

EURASIAN ECONOMIC UNION (EAEU)

The Eurasian Economic Union (EAEU) consists of 5 countries namely; Russia , Kazakhstan,Belarus, Kyrgyzstan and Armenia.As previously reported, according to the EEU Council’s decision dated May 17, 2017, theTechnical Regulation on Chemical has been adopted. The regulation will come into force as of02.06.2021 under a specific condition i.e. the regulation will come into force only if requirementsto the state Register and Order of Notification (i.e. second tier legislation) is developed andcomes into force before 01.12.2018. By 01.03.2021 the national parts of the Register must beready.Progress and trends have been comprehensively reported during the year. If the Ceficmembership requires earlier reports they can be made available on request.

SWITZERLAND

Revision of the Ordinance on Chemicals (ChemV; SR813.11): The public consultation periodended in May 2017. In early July 2017 the BAG invited industry representatives to hear theconclusions of the BAG drawn from consultation and discuss proposals on the way forward.The main elements that industry has to expect from the revision are:

Introduction of a notification requirement for marketed, dangerous intermediates inquantities of more than 100 kg / year;

Expansion of the current notification requirement for marketed dangerous chemicals to"potentially dangerous" synthetic nanomaterials (technical definition for fibre- and tube-like nanomaterials will be part of the regulation);

Introduction of the UFI for mixtures for private consumers; The following points have been dropped from the revision proposal:

Change of the definition of "Nanomaterials"; Change of sales restrictions, especially with regard to schools (Art. 64); Introduction of notification requirement for different uses by further downstream

users. This has been skipped due to strong criticism by industry, academia andalso by enforcement authorities since it would have been problematic forenforcement (Art. 71a-71c).

Current developments can also be reviewed on the BAG homepage:https://www.anmeldestelle.admin.ch/chem/de/home/themen/recht-wegleitungen/revisionen-des-chemikalienrechts/modernisierung-des-schweizer-chemikalienrechts.html)Further to be expected is the amendment of Annex 3 of the Ordinance which represents theSwiss version of the candidate list. It is likely that the entries to the REACH candidate list ofJanuary and July 2017 will be copied.


15

The entry into force of the main revision has been pushed back by one month to 1st March 2018,however the content remains as stated above.Additionally, the Federal Office for Public Health has informed of revisions of the annexesChemV; SR 813.11, as well as on the chemicals risk reduction ordinance (ChemRRV, SR814.81):Ordinance on chemicals (ChemV; SR 813.11)

Annex 2: Adaption of technical regulations on classification, labeling and packaging ofsubstances and mixtures. This implements changes in the EU CLP up to the 10th ATP(EU V 2017/776) including the dates when they become mandatory in the EU.

Annex 2: Test methods: Implementation of EU V 2017/775 Annex 3: Swiss Candidate List (SVHC): New and adapted entries of the EU REACH

candidate list of January and July 2017 are implemented into the Swiss candidate list. Annex 4: Technical dossier: the adaption of EU V 2017/706 (REACH Annex VII Test

requirements on skin sensitization) is implemented into this annex.Chemicals risk reduction ordinance (ChemRRV, SR 814.81):

Annex 1.10: Restrictions on making available to the wider public of CMR substances andmixtures according to EU V 2017/1510. The grace period for selling stocks is short (until31.08.2018) but slightly longer than in the EU (01.03.2018). Industry is supposed to beaware of the changing rules on this chemical since the publication of the 9th ATP inDecember 2016.

The changes in the above mentioned annexes will enter into force by 01st March 2018.

TURKEY

Turkey REACH (“KKDIK = Kimyasalların Kaydı, Değerlendirmesi, İzni ve Kısıtlanması) waspublished in Turkish language on 23 June 2017(http://www.resmigazete.gov.tr/eskiler/2017/06/20170623M1-18.htm) and entered into force on23 December 2017. The legal text (By-Law) and its annexes are available onhttp://kimyasallar.csb.gov.tr/mevzuat/54. The titles I –I X are the same as EU REACH. Titles X-XII correspond to EU REACH titles Xii, XIV and XV. Titles X, XI and XIII of EU REACH do notexist under Turkey REACH.KKDIK has 18 annexes:I General provisions for assessing substances and preparing chemical safety reportsII Requirements for the compilation of Safety Data SheetsIII Criteria for substances registered in quantities between 1 and 10 tonnesIV Exemptions from the obligation to register in accordance with art. 2(7)(a)V Exemptions from the obligation to register in accordance with art .2(7)(b)VI Information requirements referred to in art. 10VII Standard information requirements for substances manufactured or imported in

quantities of 1 tonne or moreVIII Standard information requirements for substances manufactured or imported in

quantities of 10 tonnes or moreIX Standard information requirements for substances manufactured or imported in

quantities of 100 tonnes or more


16

X Standard information requirements for substances manufactured or imported inquantities of 1000 tonnes or more

XI General rules for adaptation of the standard testing regime set out in annexes VII to XXII General provisions for downstream users to assess substances and prepare chemical

safety reportsXIII Criteria for the identification of persistent, bio-accumulative and toxic substances, and

very persistent and very bio-accumulative substancesXIV List of substances subject to authorisationXV DossiersXVI Socio-economic analysisXVII Restrictions on the manufacture, placing on the market and use of certain dangerous

substancesXVIII Conditions for receiving certificate of competency of chemical assessment expert

English translations are available for the By-Law and Annexes XVII and XVIII. A specificrequirement which is different from EU REACH is described in Annex XVII: “Conditions forreceiving certificate of competency of chemical assessment expert”. A certificate of competencyhas to be given by an institution that has been accredited by Turkish Accreditation Institution(TÜRKAK) for personnel certification on chemical assessment or who has worked in the Ministryin the field of chemicals management for at least 10 years shall be defined as “chemicalassessment expert” in the scope of the By-law.

A pre-registration phase is foreseen from 23 December 2017 until 31 December 2020. From 1January 2021 until 31 December 2023 all substances made or imported between 1 ton to >1000 tonnes/year have to be registered within these 3 years.The pre-registration will be done via the online portal that existed before, but it is not clearwhether this functionality is already operational. The submission will be free of charge. The pre-registration will lead into the formation of substance information exchange fora (= SIEFs underEU REACH) called “ön-MBDF”, which will enable future joint registration submissions.The standard registration fees for individual/joint submissions are 3680/2588 TL (10-100 t/a),9840/6900 TL (100-1000 t/a) and 26560/18675 TL (> 1000 t/a). Registrations for 1-10 t/a arefree. There will be reductions for medium and small enterprises.The concept of Only Representatives (OR) is the same as in EU REACH, i.e. companies fromoutside Turkey who want to import into Turkey can nominate an OR to handle the registrationon their behalf in Turkey.The implementation of KKDIK is just about to start. It is expected that further clarifications will beneeded along with the pre-registration and registration phases.As a consequence of KKDIK the following regulations have been or will be replaced:

The Inventory and Control of Chemicals (has been immediately replaced by KKDIK); Regulation on Safety Data Sheets for Hazardous Substances and Mixtures (will be

replaced by KKDIK on 31 December 2023); Regulation on Restrictions for the Manufacture, Marketing and Use of Certain

Dangerous Substances & Preparations (will be replaced on 23 December 2017).


17

UKRAINE

An English language translation of Ukraine’s draft “Technical Regulation for the safe circulationof hazardous chemicals in the internal market”, published 21 Oct. 2016, has been received andcomments submitted.The Cherkasky Institute planned to submit the draft regulation to the government in late2017/early 2018. After this the developers of the regulation will no longer be involved.In the meantime, close monitoring will be required as the government may introduce changesthat may need further advocacy. CLP is currently planned to be introduced by 2019 whileUkraine-REACH should commence 2020/21. Ukraine is exploring the idea of simplifiedregistration of ECHA-registered substances, providing that a solution to CBI and data ownershipissues can be found.

SOUTH AFRICA

As reported in Q1, on 23 September 2016, the Minister of Health published the Group I,Category B Hazardous Substances Draft Declaration, which expands the list of Group I,Category B Hazardous Substances (HCS) to include pesticides. Once the Draft Declaration isadopted, all pesticides listed under the Rotterdam and Stockholm Conventions as wellpoisonous (toxic) substances specified in Annexure E of the South African Bureau of Standardslatest Code of Practice 10228 will be considered as Group I Category B HCS that are subject tothe provisions of Regulations relating to Group I hazardous substances. It follows that thosefacilities that engage in the sale of Group I Category B hazardous substances will have to obtaina license prior to the sale of the regulated substances and keep an up to date record of suchsales. The Draft Declaration will repeal the Hazardous Substances Act, 1973 GovernmentNotice 452 as amended by Government Notice 1381 in Government Gazette 15907 dated 12August 1994.GERSouth African Department of Environmental Affairs has published a Draft National ChemicalsManagement Policy. The draft policy outlines existing chemicals legislation in South Africa,emphasising a lack of specific legislation for the environment. Five policy proposals are given:

1. Explicit implementation of international treaties in South African legislation (e.g.Basel, Rotterdam, Stockholm and Montreal).

2. Creation of horizontal legislation for the risk assessment of chemicals, inparticular including for the environment.

3. Creation of a multi-stakeholder committee on chemicals management, tocoordinate the current and proposed chemicals related activities of variousgovernment departments.

4. Development of information management system on chemicals in South Africa.5. Review of South African chemicals legislation, in particular environment related,

to establish whether they are currently administered by appropriate departments.The Chemical and Allied Industries Association has been challenging the policy positions whichhave been put forward.


18

US

In Q2 it was reported that it had been a year since the LCSA was signed. The Frank R.Lautenberg ChemicalSafety for the 21st Century Act (LSCA) substantially amended TSCA, was signed intolaw 22 June16, Since then EPA has been going through the regulatory process to finalizethe framework rules to implement the changes to TSCA (e.g. public stakeholder meetings,seeking comments on draft rules, etc.).The following provides an insight into what has transpired since and other regulatorydevelopments.

• Labelling prohibition for formaldehyde products was removed by EPA in July:https://www.epa.gov/formaldehyde/formaldehyde-emission-standards-composite-wood-products

TSCA Prioritization- The LCSA contains provisions for risk-based prioritization of existing chemicals- EPA published the final rule “Procedures for Prioritization of Chemicals for Risk

Evaluation Under the Toxic Substances Control Act.” [82 FR 33753-33764, July 20,2017]

TSCA Risk Evaluation- Under the LCSA, EPA will conduct risk evaluation of high priority chemicals and to regulate if

it determines that a chemical presents an unreasonable risk- EPA published the final rule “Procedures for Chemical Risk Evaluation Under the Amended

Toxic Substances Control Act.” [82 FR 33726-33753, July 20, 2017]

TSCA Risk Management- Under the LCSA, EPA will develop risk management requirements if it determines that a

chemical presents an unreasonable risk.- EPA has published several proposed rules under TSCA Section 6(a)- EPA released Guidance to Assist Interested Persons in Developing and Submitting Draft Risk

Evaluations, and the scope documents for risk evaluation for the first 10 chemicals to undergorisk evaluation

TSCA Inventory and PMNs (existing chemicals)- “New” chemicals not on the TSCA Inventory require pre-manufacture notification (PMN) to

EPA before commercial manufacture or import may begin, unless exemption applies.- EPA announced that it has eliminated the backlog of new chemical review cases that

developed following June 2016 enactment of the LCSA- EPA announced that in Fall 2017, EPA’s Office of Pollution Prevention and Toxics (OPPT)

intends to release, for public comment and stakeholder engagement, draft documents that willprovide the public with more certainty and clarity regarding how EPA makes new chemicaldeterminations and what external information will help facilitate these determinations.

TSCA CDR and Inventory reset- The Chemical Data Reporting (CDR) rule requires submission of chemical information

through EPA’s online system once every four years. [76 FR 50816 - 50879, August 16,2011]


19

- EPA is planning to revise CDR reporting requirements before the 2020 reportingperiod. The target date for a proposed rule is May 2018.

- LCSA requires EPA to publish a rule to require manufacturers and possibly processors toreport chemicals manufactured or processed in the past 10 years.

- Reporting under TSCA Inventory Notification (Active-Inactive) Requirements, aka the TSCAInventory Reset is now open. [82 FR 37520-37544, August 11, 2017].Manufacturer / Importer deadline is 7 February 2018. Joint submission process available.

Current data call in for 5 PBTs.* Decabromodiphenyl ethers (DecaBDE) used as a flame retardant in textiles, plastics, wiringinsulation, and building and construction materials;* Hexachlorobutadiene (HCBD), used as a solvent in the manufacture of rubber compoundsand as hydraulic, heat transfer or transformer fluid;* Pentachlorothiophenol (PCTP), used as a mercaptan (sulfur) cross-linking agent to makerubber more pliable in industrial uses;* Phenol, isopropylated, phosphate (3:1), used as a flame retardant in consumer productsand as lubricant, hydraulic fluid, and other industrial uses; and* 2,4,6-Tris(tert-butyl) phenol, an antioxidant that can be used as a fuel, oil, gasoline orlubricant additive.EPA has established five separate dockets, which are currently open, for each of the PBTchemicals to be regulated. All information submitted to the dockets must be received byDecember 9, 2017. There are several ways that information can be submitted to thedocket. More guidance on submitting comments to EPA dockets can be foundat: https://www.epa.gov/dockets/commenting-epa-dockets.

TSCA CBI- The LCSA includes confidential business information (CBI) substantiation requirements and

10-year duration/expiration for CBI (renewable).- EPA published a notice interpreting revised TSCA section 14(c) (3). [82 FR 6522 – 6525,

January 19, 2017]

TSCA Fees- The LCSA provides for fees to support EPA’s chemical regulation program. Target date of

August 2017 for a proposed rule. By June 2018, EPA must report to Congress on feescollected and funds dispersed

Nanotech- EPA issued a final TSCA section 8(a) rule for reporting and recordkeeping of existing

exposure and health and safety information on nanoscale chemical substances [82 FR 3641– 3655, January 12, 2017]. Effective date extended to August 14, 2017. [82 FR 22088 -22089, May 12, 2017]. New EPA’s guidance published on gathering information and reportingof nanomaterials:

https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/working-guidance-epas-section-8a

EPA developing strategic plan for vertebrate TSCA testingAs required by the Section 4(h) of the 2016 amendments to TSCA, the EPA is in the process of

preparing a strategic plan “to promote the development and implementation of alternative testmethods and strategies to reduce, refine, or replace vertebrate animal testing.” Under thesection, the alternatives and strategy must provide information of equivalent or better scientific


20

quality and relevance that will support TSCA regulatory decisions, the final strategy is due byJune 2018.On November 2, EPA held a public meeting to obtain input from interested parties and the

public on the Agency's development of the Strategic Plan The meeting was co-organized byEPA and NICEATM (Division of the National Toxicology Program, National Institute ofEnvironmental Health Science). The Agency will consider input from the meeting and fromwritten comments to develop a draft Strategic Plan that will be shared with the public forcomment.

Recording of plenary session webcast on National Institutes of Health Video cast site:https://videocast.nih.gov/summary.asp?Live=26469&bhcp=1

For access to documents and to provide written comments please follow link:https://www.regulations.gov/docket?D=EPA-HQ-OPPT-2017-0559Sources:- NTP website: https://ntp.niehs.nih.gov/pubhealth/evalatm/3rs-meetings/past-

meetings/tsca-2017/index.html- EPA website: https://www.epa.gov/assessing-and-managing-chemicals-under-

tsca/alternative-test-methods-and-strategies-reduce- Chemical Watch: https://chemicalwatch.com/60985/us-epa-has-first-public-input-on-

alternative-test-methods-for-tsca

EPA proposes TSCA mercury reporting ruleAs required under section 8(b)(10)(D) of TSCA, EPA is proposing reporting requirements in

order to prepare an “inventory of mercury supply, use, and trade in the United States,” where“mercury” is defined as “elemental mercury” and “a mercury compound”.On October 26, 2017 EPA published the proposed rule to require reporting from persons whomanufacture or import mercury or mercury-added products, or otherwise intentionally usemercury in a manufacturing process.

Source: EPA website.

BRAZIL

Background and Public ConsultationA Working Group under the National Commission on Chemical Safety (CONSAQ) assessedalternative schemes from various countries. The outcome was that industry should provide datafor government assessment, with a focus on prioritisation. An inventory will be set up to providea pool of substances for prioritisation. A subset will be selected for review by a technicalcommittee formed from the Ministries of Environment, Health, Labour, and Industry.Manufacturers and importers will be requested to provide information on the substances, thetechnical committee will perform a risk assessment, with risk management measures (or otherregulatory control measures) an outcome. At this stage it appears limited information would berequired for setting up the inventory, and new substances would enter the prioritisation pool,rather than require upfront registration. Prioritisation criteria are proposed as Persistence,Bioaccumulation, Ecotoxicity, CMR, Endocrine Disrupters, relevant human health and


21

environment exposure, and “international alerts” (note criteria appear to be more stringent thanPBT)..A useful opinion of the planned chemical legislation in Brazil can be found in the following link:https://www.linkedin.com/pulse/understand-better-brazilian-politics-industrial-jairo-andrade-junior

Situation as currently UnderstoodThe National Commission on Chemical Safety (CONASQ) is currently reviewing the 1023comments received during the public consultation of the draft legislation that took place betweenJune and September 2016. A document with responses to the contributions stating itsacceptance or rejection was expected by the end of 2017. CONASQ is holding regular andextraordinary meetings to meet this timeline and have divided the inputs into four categories: amatter of law, a matter of regulations (secondary level law), out of scope, and doubts and otherissues. In addition, an independent study on the regulatory risk is being performed byconsultants to evaluate the impacts on economy and society before, during and after entry intoforce of the draft legislation. This document aims to support the political approval process.Once the CONASQ response to the comments is published, an amended draft including theaccepted contributions will be produced. This document will need to be approved as a final draftby CONASQ and subscribed by the Ministers of Environment, Health, Labor and Industry.Afterwards, the final draft Law is to be sent to the Congress for approval and will only enter intoforce after final approval by the President of the Republic. The approval timeline is uncertain.

COLOMBIA

Progress continues on the Chemical Management Decree in their bid to become an OECDmember. Work is ongoing to establish an inventory and risk assessment procedures.It is understood that there is a Latin America project ongoing in which Argentina is taking a leadrole. The group agreed that this is important to the network members.In the Q2 report, a comprehensive interpretation of the Draft Decree was provided. This isprovided below. Since Q2 and following a meeting with the Colombian Ministry of Environment´sAuthorities (CME) that took place on September 14th in Bogotá the following information has beenreceived:

- CME’s goal is to publish the regulation by the end of November, in which they proposeto start developing a 2 years’ chemical inventory of Colombia from January 2018 to Dec2019.

- CME continues with the idea of including homogeneous mixtures (probably trying to usethe UVCB concept). However, the "homogeneous mixture" definition needs to be clarified.

- The inclusion of flavours and feeding as exemptions remains unclear. (In most regulationsworldwide they are normally covered by other pieces of legislation).

- It is likely that Risk Assessment and Risk Management activities will be carried out bythe companies and published on their web pages. This aspect gives rise to concern forthe protection of CBI.


22

- Risk Assessment and Risk Management regulations will be discussed in 2018 anddefined by the guidelines that will be established. Several workshops are planned for thesetopics.

- GHS: Companies raised the need to establish the GHS criteria for classification beforebeginning the inventory. It is understood that the GHS decree will be submitted for publicconsultation soon with a view for publication this year.

- Although the government used the IOMC tool box(http://iomctoolbox.oecd.org/default.aspx?idExec=19460334-202b-4bd8-9028-6b0251e78fb2 ) to build the chemical management law proposal, there are manytechnical concepts regarding chemical prioritisation, risk assessment and riskmanagement, data property, impacts on supply chain competitiveness (specially forsmall and medium sized businesses) and innovation, criteria for acceptance of data andinternational cooperation that need to be considered further.

Interpretation of the Draft Decree.The Decree is only available in Spanish but available on request.Version: 0102_2017ScopeRegistration of chemical substances for industrial usage.

Risk evaluation to health and the environment and according to the specific usage Program for risk (health and / or environment) management.

Industrial usageThis refers to any transformation, formulation, consumption, storage, preservation, treatment,packaging, transfer, mixing, production of an article or any other use of chemicals in the industry.RegistrationAll manufacturers and/or importers of industrial chemicals are requested to classify and identifythe hazards of the substances according to GHS.Such a hazard identification and classification of the substance, the potential use of the

substance in the country, as well as additional information determined by the competent authority,should be included in the Register of Chemicals for Industrial Usage by the manufacturer and / orimporter.GHS has not been implemented in Colombia yet. The Colombia GHS draft regulation wentthrough public consultation from December 15th to December 26th. According to article 28, theperiod for GHS implementation will be: Substances: 36 months and Mixtures 48 months form thepublication in the Colombia Official Gazette.The deadline for Registration is January, 2020. There is no mention to a specific month nor dayin the regulation.Self-assessments on risks to health and environment of chemical substances for industrialuse (article 6, second paragraph):As of 2020, chemical substances for industrial use that are intended to be imported ormanufactured should be registered.Those chemicals which fall under the classification as CMR, PBT or Acute (short-term) hazard tothe environment, require environmental and health risk reduction management programs carriedout by the manufacturer and / or importer.Self-assessment on risk to environment (article 7): All manufacturers or importers of chemicalsubstances for industrial usage referred to in article 6 should undergo a self-assessment of riskto environment based on guidelines issued by the Ministry of Environment and SustainableDevelopment.


23

Self-assessment on risk to health (article 8): All manufacturers or importers of chemicalsubstances for industrial use referred to in article 6 should carry out the self-assessment of riskto health based on guidelines issued by the Ministry of Health and Social Protection.Inspection on self-assessment of risk to the environment (article 9): The NationalEnvironmental Licensing Authority (ANLA) may at any time require importers or manufacturers tosubmit their self-assessments of chemical environment risk in order to verify its compliance withthe provisions and in case of default will impose the preventive and sanctioning measures.Inspection on the self-assessment of risk to health (article 10) The Ministry of Health and

Social Protection may at any time require importers or manufacturers to submit their self-assessments of chemical health risk in order to verify compliance with the provisions and in caseof default will impose the preventive and sanctioning measures.Program for risk (health and / or environment) management (articles 11 and 12): Allmanufacturers or importers of chemical substances for industrial use referred to in article 6 shouldperform programs for the reduction and management of risk to the environment and/or healthbased on the guideline issued by the Ministry of Environment and Sustainable Development /Ministry of Health and Social Protection.Tasks and duties: Importers or Manufacturers (article 20)

a) Integral management of chemical substances of industrial usage which it imports ormanufactures;

b) Identification, classification, labeling and Safety Data Sheet (SDS) of chemical substancesfor industrial usage, according to the Globally Harmonized System of Classification andLabeling of Chemicals (GHS);c) Provide information required by the Ministry of Commerce, Industry and Tourism throughthe mechanism defined for this purpose;d) Perform self-assessments of risk to environment and health of chemical substances forindustrial use, in accordance with guidelines issued by the Ministry of Environment andSustainable Development and the Ministry of Health and Social Protection;e) Develop and implement programs containing risk management actions to health andenvironment of chemical substances for industrial use, in accordance with guidelines issuedby the Ministry of Environment and Sustainable Development and the Ministry of Health andSocial Protection;f) Carry out the adjustments in the risk assessments and in the risk management programsfor health and environment requested by the competent authorities;g) Prepare the annual report on compliance with the risk management programs for health

and environment and make it available to the competent authorities;h) Submit the information required by the competent authorities with respect to the annual

compliance report, using the mechanism designated for this purpose;i) Support and participate in research processes on risk management related to industrial

chemicals;j) Comply with Decree 1079 of 2015 when shipping chemical substances of industrial use;k) Manage the waste of chemical substances for industrial usage as Decree 1076/2015