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September 1, 2018

Global Regulatory Update for September 2018

The ACTA Group

New Book Provides Vital Guidance Regarding Chemical Regulation In The Middle East: The Acta Group (Acta®) and Bergeson & Campbell, P.C. (B&C®) are pleased to announce the publication of Chemical Regulation in the Middle East, written by Michael S. Wenk, M.S. This first of its kind handbook offers an essential guide to the patchwork of chemical regulatory programs and the complex system of permits and licenses that manage chemicals in the countries of the Middle East. It also explores the range of ministry, legislative, and other decrees that encompass pesticides, occupational safety and health, as well as safety data sheets (SDS) and product labels that address regulation to widely-varying degrees. Readers of the book will gain a thorough understanding of the regulatory programs, the agencies and entities involved, the legislation in force, and the key areas of concern for compliant and commercially successful operations across the Middle East. An Executive Summary of the book is available on Acta’s website. Chemical Regulation in the Middle East is available for purchase via the John Wiley and Sons Ltd. website.


Technical Regulation On Agricultural Fertilizers Released: The Ministério da Agricultura, Pecuária e Abastecimento (Ministry of Agriculture, Livestock and Supply; MAPA) has issued Instrução Normativa Nº 39, de 8 de Agosto de 2018 (Technical Regulation). The Technical Regulation, which revokes the previously applicable Instrução Normativa Nº 46, de 22 de Novembro de 2016, establishes rules on definitions, requirements, specifications, guarantees, products, authorizations, packaging, labeling, tax documents, advertising, and tolerances of fertilizers intended for agriculture. The manifest purpose is the protection of human, animal, and plant life and health.

Bill To Reduce Pesticide Risk Considerations Moves Forward: The Special Commission of the Câmara dos Deputados (Chamber of Deputies; the lower house of the National Congress of Brazil), responsible for analyzing changes suggested to Brazil’s 1989 national pesticide law, has approved Bill 6299/2002 (Bill). The Bill changes the manner in which pesticide registration applications are evaluated in the country, specifically by allowing pesticides having teratogenic, carcinogenic or mutagenic characteristics, or that cause hormonal disturbances and damage to the reproductive system, to be registered. Further, it would adopt a “risk analysis” evaluation, instead of the current assessment that prioritizes the identification of (the) dangerous substances. The Bill replaces the currently in force national pesticide law’s ban terminology with the phrase “unacceptable risk”; that is, it authorizes registration in situations where the use remains unsafe even when implementing risk management measures. The Bill also removes the criminal liability of an employer in cases of non-compliance.

As might be imagined, a wide cross-section of public and private citizens, non-governmental organizations (NGO), activist groups and others are significantly alarmed by the passage of the Bill. The Ministério Público Federal (Federal Public Ministry; FPM), the Brazilian body of independent public prosecutors at both the federal and state levels, has asserted that the Bill is unconstitutional, citing two specific reasons (and alluding to multiple others): it exempts sellers of the duty to warn consumers about the harm resulting from the use of pesticides, and it prohibits states and the Federal District from legislating on the matter. In this vein, the FPM’s Câmara do Meio Ambiente e Patrimônio Cultural (Chamber of Environment and Cultural Patrimony) provided the Congress with a “technical note” that outlines at least six articles of the Constitution it believes have been violated.

The Bill now moves to the plenary of the Câmara dos Deputados, and then to the Federal Senate.

Brazilian Judiciary Bans Glyphosate: A Brazilian federal judge has issued a ruling that further sales of glyphosate-containing products are prohibited, as are registrations of new products containing the substance, until the government re-evaluates its toxicology. Glyphosate-containing products are widely used in soybean production in the country, and Brazil is the world’s largest exporter of the product. The ruling particularly affects Monsanto, which produces a glyphosate-resistant GMO soybean product extensively marketed in the country. The decision also applies to the insecticide abamectin and the fungicide thiram.


Canada Publishes Laboratory Test Method To Identify Microbeads In Toiletries: On September 6, 2018, Canada published a laboratory test method to identify microbeads in toiletries. Canada has determined that microbeads are toxic to the environment under the Canadian Environmental Protection Act, 1999 (CEPA). The Microbeads in Toiletries Regulations prohibit the manufacture and import of microbead-containing toiletries in Canada. The laboratory test method is used to support the analysis of microbeads in toiletry products. Canada states that the method uses water, a mixture of water and organic solvents, or pure organic solvents to dissolve the non-plastic components of the product and by using sieving and/or filtration, the undissolved components are isolated. The presence of plastics is confirmed using Fourier Transform Infrared Radiation (FT-IR). The manufacture and import of all toiletries that contain plastic microbeads was prohibited as of July 1, 2018. The sale of toiletries that contain plastic microbeads is also prohibited, unless the toiletries are also natural health products or non-prescription drugs, in which case the prohibition will begin July 1, 2019.

Assessment Collaboration Framework Between EPA, ECCC, And HC Published: The Assessment Collaboration Framework between the U.S. Environmental Protection Agency (EPA), Environment and Climate Change Canada (ECCC), and Health Canada (HC) was published on September 7, 2018. In 2011, the U.S. and Canada launched the Regulatory Cooperation Council (RCC) to facilitate closer cooperation between Canada and the U.S. on the development of more effective approaches to regulation that strengthen the economy, enhance competitiveness, and provide greater protection to public safety and welfare. The Framework notes that EPA, ECCC, and HC have common policy objectives under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and CEPA to reduce risks posed by chemicals to human health and the environment. According to the Framework, the agencies share similar principles with respect to the assessment of chemicals, including:

  • Protection of the environment and human health;
  • Risk-based approaches;
  • Scientific integrity;
  • Cooperation in support of efficient and robust decision-making (e.g., fit-for-purpose);
  • Transparency, engagement, and continued communication with stakeholders, including the public; and
  • Commitment to process (e.g., ongoing identification of priorities, continuous improvement/modernization, accountability, reporting, performance measurement, continuing collaboration).

The participating agencies recognize that the Framework focuses on areas of technical collaboration on science and regulatory issues and practices related to chemical assessments. Issues pertaining to policy development in this area are generally considered beyond the scope of the Framework. Work under the Framework may identify or inform policy issues, however. The overall goal of the Framework is to facilitate and enhance collaboration between the three agencies for the risk-based assessment of chemicals within their respective legislative and regulatory context. Stakeholder engagement and broad communication to the public are additional goals of the Framework. The Framework states that it will enable enhanced alignment on risk assessment of chemicals, including identification of risk assessment priorities, information gathering and sharing, risk assessment methodologies, work sharing, and joint assessments. The goals will be achieved through the implementation of a Rolling Work Plan, published in an appendix to the Framework. According to the Framework, Rolling Work Plan elements will be reflected in the annual operational plans of each government.


Björn Hansen Responds To ChemSec’s Letter: As reported in Acta’s August Update, the International Chemical Secretariat (ChemSec) issued “A letter to Björn Hansen” on July 3, 2018. In its letter, ChemSec suggested that “[the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation] is not delivering at the pace that could be expected” and expressed concern in this regard. ChemSec’s letter posed to Björn Hansen, Ph.D., the European Chemicals Agency’s (ECHA) Executive Director, several specific questions. On July 17, 2018, Dr. Hansen responded to ChemSec’s letter, stating:

As stipulated in Article 1 of REACH and articulated in the Commission’s REACH General Report, I will, within the mandate of ECHA, focus on protecting human health and the environment and preserving the internal market. In doing so, innovation and competitiveness will be enhanced. I will also promote non-animal test methods, for example, through the [Organization for Economic Cooperation and Development (OECD)] [Quantitative Structure-Activity Relationship (QSAR)] Toolbox. Whether this focus is greater than before is best left to you and others to judge.

Dr. Hansen provides that he agrees “with the findings of the Commission’s REACH General Report, in particular that implementation of REACH has to become more efficient and needs to deliver quicker.” Dr. Hansen further stated that “[t]his does not contradict the finding that the implementation of the [Substances of Very High Concern (SVHC)] Roadmap is ‘progressing beyond expectations’ nor that this part of REACH has promoted innovation and substitution … Much of REACH needs to improve, but the SVHC Roadmap is doing well.”

Regarding the specific questions posed to Dr. Hansen, the letter provided the following responses:

ChemSec: ECHA’s progress report on the SVHC roadmap states “all currently known relevant [SVHCs] have been addressed. Which substances are seen as relevant and which are not? Do you agree that non-registered substances could also be relevant for the Candidate List?

ECHA: The definition of “relevant” was set jointly by the [European Commission (EC)] and Member States. ECHA implements it. Up to 2020, non-registered substances should not have priority for Candidate Listing, unless they form part of a group. In fact, ECHA itself listed several of such substances.

ChemSec: In your view, are classified [carcinogenic, mutagenic, or toxic for reproduction (CMR)] substances adequately regulated through the requirements that apply following their classification?

ECHA: CMRs are not necessarily adequately regulated through the requirements that apply following classification. The purpose of risk assessment, by industry or authorities, is to assess if this is the case for each CMR. As part of the SVHC Roadmap, authorities have assessed (not risk assessed) all substances with a CMR classification to see whether they need further regulation. Once this assessment is done we say the substance has been “addressed.” They concluded for a number of them that, at the moment, there is no need for further action at the EU level. This relates, for example, to the fact that these substances have often had a harmonized classification as CMRs for many years, and hence are highly regulated under REACH and other legislation, or they are not registered. These conclusions are reviewed regularly to observe any changes in use patterns or other information that would change this conclusion.

ChemSec: What is your view on listing restricted substances on the Candidate List and vice versa?

ECHA: Except for CMRs, the identification as an SVHC can facilitate the discussions of a restriction proposal. Conversely, existing restrictions are taken into account when considering the need for further measures, including inclusion in the Candidate List. However, apart from those for which a full ban is in place, no substances are excluded from the screening based exclusively on an existing restriction.

ChemSec: What is your plan to assure that the discussions in the expert groups actually bring substances closer to the Candidate List and will not continue to serve as a way of keeping substances off the regulatory radar for a number of years?

ECHA: We are generating data for or assessing 750 substances, many of which have so far not been on the radar screen of the authorities. As you state, information generation is time-consuming when it concerns long-term effects. We are continuously working with national authorities to keep the timelines as short as possible, including effective use of the expert groups and we have started implementing the REACH General Report actions to significantly speed up the evaluation processes. However, as a science-driven agency we need scientifically valid information to identify substances as SVHCs.

ChemSec: According to a statement by Geert Dancet, an important reason for the slow pace of listing substances on the Candidate List is huge pressure from industry. How will ECHA assure that it resists this pressure more effectively and sticks to the scientific hazard criteria for Candidate Listing?

ECHA: I am not sure in which context my predecessor said this, but I can assure you that it is our goal to bring the authorization process, including the Candidate List, to its effect, to protect citizens and the environment, and to stimulate substitution and innovation. As an independent Agency we are well set up for being resilient against external pressure.

Dr. Hansen states in the letter that ECHA will be developing further its “Integrated Regulatory Strategy” to take into account the learnings from the first years of applying REACH with the aim to further streamline the work and push for further integration of evaluation, restriction, and authorization work and speed up identification of and regulatory actions on new substances of concern. Dr. Hansen highlighted that addressing groups of structurally similar substances is a key feature of this strategy.

Anne-Sofie Andersson, ChemSec Executive Director, responded to Dr. Hansen on August 24, 2018. Andersson stated that she is not reassured by Dr. Hansen’s answers on question number four and five, relating to how ECHA “will ensure that substances do not get stuck in expert groups, but that SVHCs gets listed at a higher pace; and on how to assure that certain industry strategies to slow down the system will not be successful.” Andersson acknowledges that data generation takes time, but ChemSec “would like to see ECHA’s committees and expert groups to more often act on the available data without routinely asking for more information. Asking for more data is very effectively slowing down substance evaluation and identification of new SVHCs, not only because data generation takes time, but because requirements for new data are routinely overruled.” Andersson notes that there is a need to change the organizational culture, and suggests that “a better use of the precautionary principle will help to speed up the identification of SVHCs.”

Member States Highlight Concerns Regarding European Chemicals Policy Delays: On July 27, 2018, environment and health ministers from Finland, France, Germany, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Slovakia, and Swedenissued a letter to several high-ranking officials at the EC. The letter starts with the following statement: “[i‌]n the past four years you have enabled us to make progress on EU environment policy, especially focusing on climate change and circular economy, which we intend to continue to take forward ambitiously. With this letter we would like to stress the importance of progress in EU chemicals policy.”

The letter cites the 7th Environmental Action Plan (EAP) and reminds EC officials of the EU’s commitment to safeguarding the health and well-being of its citizens, including by strengthening chemicals policy. The letter further states “[i‌]ndeed, the sound management of chemicals is not only vital to protect our citizens and environment, but also to strengthen EU competitiveness and innovation … It is a challenging policy area that urgently requires us to develop and enhance policy frameworks and provide direction to citizens and industry … The 7th EAP sets out clear actions with timelines on how to achieve this.”

The letter provides that, “[a]s we reach the end of this Commission’s term,” the ministers are seriously concerned regarding the delay of several initiatives that are foreseen to advance chemical policy, and that are necessary to achieve a circular economy. In particular, the letter refers to:

  • The strategic approach to pharmaceuticals in the environment (announced for 2015).
  • The strategy for a non-toxic environment (announced for 2018) including the horizontal measures announced in the EAP for 2015 to ensure: (1) safety of manufactured nanomaterials and materials with similar properties; (2) minimization of exposure to endocrine disruptors; (3) appropriate regulatory approaches to address combination effects of chemicals; and (4) minimization of exposure to chemicals in products with a view to promoting non-toxic material cycles and reducing indoor exposure to harmful substances.
  • The integrated product policy framework (announced for 2018, the circular economy action plan).
  • The strategy on endocrine disruptors to minimize exposure of EU citizens to endocrine disruptors, beyond pesticides and biocides, covering cosmetics, toys, and food packaging.

In the letter, the ministers note that “some progress is made” on certain elements of chemicals policy, such as criteria for endocrine-disrupting substances, the REACH review, and the REACH annex for nanomaterials. Despite this progress, the ministers assert that “important gaps in our legal and policy framework remain.” In conclusion, the letter states “[i‌]n order to achieve the goals we have set for 2020 and to avoid any further delay, we hereby urge you to facilitate the swift development of EU policy and to present these proposals within the term of the current Commission …. We are ready to cooperate and to contribute to the development of these initiatives.”

Lower Concentration Limit Proposed For Eight PAHs: On August 16, 2018, ECHA issued a press release entitled “Lower concentration limit proposed for [polycyclic aromatic hydrocarbons (PAH)] found in granules and mulches.” In its press release, ECHA provides that the Netherlands has prepared a proposal to support a possible restriction to address the risks from eight PAHs found in granules and mulches used in synthetic turf pitches, or in loose forms at playgrounds and other sports facilities. The proposal, prepared by the Dutch National Institute for Public Health and the Environment (RIVM) in cooperation with ECHA, states that the general concentration limits set under REACH for eight carcinogenic PAHs in mixtures are insufficient for protecting those who come into contact with the granules and mulches while playing at sports facilities and playgrounds.

The proposal suggests a combined concentration limit for the eight PAHs of 17 mg/kg (0.0017 percent by weight). The current concentration limits applicable for supply to the general public are set at 100 mg/kg for two of the PAHs and 1000 mg/kg for the other six. The PAHs are:

  • Benzo[a]pyrene;
  • Benzo[e]pyrene;
  • Benzo[a]anthracene;
  • Dibenzo[a,h]anthracene;
  • Benzo[‌b]fluoranthene;
  • Benzo[j]fluoranthene;
  • Benzo[k]fluoranthene; and
  • Chrysene.

The Netherlands’ proposal outlines that the suggested reduction in the concentration limit would: (1) ensure the cancer risk from PAH exposure remains very low for those coming into contact with the granules and mulches; (2) decrease societal concerns about the negative health impacts caused by the PAHs; (3) lead to no major additional administrative burdens on public authorities in terms of costs for implementing the lower concentration limit; and (4) cause relatively limited and affordable societal costs.

ECHA’s committees will assess whether the restriction dossier conforms to the requirements of REACH. If so, a six-month long consultation period will begin in September 2018. ECHA’s scientific committees will assess the proposal and formulate their opinions, which will be submitted to the EC. In addition to processing the Netherlands’ proposal, ECHA will assess “as requested by the [EC] — the health risks of other substances that may be contained in granules and mulches used as infill in synthetic sports pitches.”

EP Committee Approves Rules Intended To Ensure Better Checks And Safety Of Consumer Products: The European Parliament (EP) Committee on the Internal Market and Consumer Protection approved on September 3, 2018, two legislative proposals intended to ensure better checks and the safety of goods sold in the EU. According to the Committee’s September 3, 2018, press release, the legislation includes provisions that address:

  • Stepping up cooperation to detect faulty products: The proposed regulation on compliance and enforcement provides for the authorities responsible for market surveillance to cooperate and coordinate better, based on an increased exchange of information on faulty products and ongoing investigations, and through the creation of an EU Network;
  • Online sales: The new rules require EU Member States to ensure proper market surveillance of products sold online to protect consumer health and safety;
  • Reference person required for non-EU companies: All companies selling products in the single market, including those from non-EU countries, will have to designate a person in the EU who can be contacted directly about compliance issues and must remedy any case of non-compliance; and
  • Improving mutual recognition: The mutual recognition principle requires that a good that is lawfully marketed in one EU Member State should not be banned in another EU Member State. The proposed regulation on mutual recognition aims to reduce trade barriers within the single market, simplify procedures for companies and national authorities, enhance cross-border cooperation, and improve problem solving.

The Committee’s approval of the proposed legislation gives rapporteurs a mandate (still to be green-lighted by plenary) to begin talks with the Council of the EU to reach an agreement on the final legislation. The Council reached a general approach on the mutual recognition proposal on May 28, 2018, but it still must agree on its position on the compliance and enforcement proposal. Three-way talks between the EP, Council, and EC can only start after that.

Registration Numbers Granted To 32,515 REACH 2018 Registrations: On September 3, 2018, ECHA issued a press release entitled “Registration numbers granted to 32 515 REACH 2018 registrations.” In its press release, ECHA states:

Registration numbers have been granted to 32 515 dossiers out of the 33 363 dossiers that were submitted by the final REACH registration deadline on 31 May. These registrations cover 10 708 chemicals. The other dossiers still lack information and ECHA is waiting for companies to update them before granting registration numbers.

ECHA provides that, under REACH, it is required to check the completeness of each registration within three months of the registration deadline if the registration for an existing (phase-in) substance was submitted in the last two months before the deadline. ECHA completed this task for 2018 registrations by August 31, 2018. ECHA indicates that the vast majority of companies were able to submit complete dossiers. For remaining incomplete dossiers, ECHA is awaiting further information from companies. Remaining 2018 incomplete submissions include 477 cases where companies faced exceptional circumstances as defined by the Directors’ Contact Group (DCG). In these cases, companies submitted their dossier with a DCG solution and were granted an extension for submitting the missing information.

ECHA expects to conclude on all pending cases by May 2019. ECHA indicates that “[t]he non-confidential data of 99.7 [percent] of all completed registrations has already been published on ECHA’s website.” In conclusion to its press release, ECHA reminds companies of their legal responsibilities regarding ensuring safe use of chemicals and keeping registrations up to date (e.g., production volumes, new uses).

ECHA indicates that further advice and information on keeping registrations up to date will be provided in November 2018, when ECHA launches Phase 7 of the REACH 2018 Roadmap. ECHA reminds registrants to check regularly their REACH-IT accounts for communications from ECHA. Additional information is available in ECHA’s REACH 2018 statistics.

ECHA Begins Public Consultation On Identification Of SVHCs: ECHA began a public consultation on September 4, 2018, on the identification of six substances as SVHCs:

NameProposing AuthorityReason for Proposing
2,2-bis(4’-hydroxyphenyl)-4-methylpentaneSwedenToxic for reproduction (Article 57c)
Benzo[k]fluorantheneBelgiumCarcinogenic (Article 57a) Persistent, bioaccumulative, and toxic (PBT) (Article 57d) Very persistent and very bioaccumulative (vPvB) (Article 57e)
FluorantheneBelgiumPBT (Article 57d) vPvB (Article 57e)
PhenanthreneFrancevPvB (Article 57e)
PyreneFrancePBT (Article 57d) vPvB (Article 57e)
Undecafluorohexanoic acid and its ammonium saltGermanyEquivalent level of concern having probable serious effects to human health and environment (Article 57f)

ECHA states that comments are particularly welcome on PBT or vPvB properties and on properties giving rise to an equivalent level of concern. Comments and further information related to uses, volumes per use, exposure, alternatives, and risks of the substance are also welcome. ECHA notes that this further information will not be used to confirm the SVHC identification, but will be used during the next step in the authorization process to help ECHA decide if the substance should be recommended for inclusion in the Authorization List. Registration dossiers are the main source of information for the recommendation of substances from the Candidate List to the Authorization List, however. According to ECHA, the Member State who submitted the SVHC proposal or ECHA will respond to any comments received. Comments relevant for the identification of the substance as an SVHC will be forwarded to the Member State Committee (MSC), and the Committee will assess whether the substance should be identified as an SVHC. Comments are due October 19, 2018.

ECHA Proposes 18 Substances For REACH Authorization List: On September 5, 2018, ECHA issued a press release entitled “Public consultation on 18 substances proposed for authorisation under REACH.” In its press release, ECHA states that it is considering recommending the EC to include 17 substances in the Annex XIV REACH Authorization List. The substances, listed in the Annex to ECHA’s press release, are:

  • Bisphenol A;
  • Dechlorane plus;
  • Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) with ≥0.1% w/w 4-heptylphenol, branched and linear (4-Hbl);
  • 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia4-stannatetradecanoate (DOTE);
  • Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4- octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE);
  • 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol with ≥ 0.1% of Michler’s ketone or Michler’s base;
  • Dioxobis(stearato)trilead;
  • Fatty acids, C16-18, lead salts;
  • Trilead dioxide phosphonate;
  • Sulfurous acid, lead salt, dibasic;
  • [Phthalato(2-)]dioxotrilead;
  • Trilead bis(carbonate) dihydroxide;
  • Lead oxide sulfate;
  • Cyclohexane-1,2-dicarboxylic anhydride [1], cis-cyclohexane-1,2-dicarboxylic anhydride [2], trans-cyclohexane-1,2-dicarboxylic anhydride [3] (HHPA);
  • Hexahydromethylphthalic anhydride [1], Hexahydro-4-methylphthalic anhydride [2], Hexahydro-1-methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] (MHHPA);
  • Tetraethyllead;
  • 2-methoxyethanol; and
  • 2-ethoxyethanol.

ECHA invites comments and further information on the uses of these substances and possible exemptions from the authorization requirement, and information on the structure and complexity of supply chains. Comments can be provided until December 5, 2018. In parallel to ECHA’s public consultation, the EC is “calling for information on the possible socio-economic consequences of including these 18 substances in the [Authorization List].” Information received in this regard will be “passed on directly to the [EC] and will not be considered by ECHA.”

MSC will prepare an opinion on ECHA’s draft recommendation, taking into consideration the comments received during the public consultation. Based on MSC’s opinion and the public consultation, ECHA will provide its final recommendation to the EC. The EC will decide on which of the substances to include in the Authorization List, and on the respective conditions applicable for each substance.

EU-OSHA Publishes Infosheets On Dangerous Substances: On September 10, 2018, the European Agency for Safety and Health at Work (EU-OSHA) announced that as part of the 2018-2019 Healthy Workplaces Campaign, it published two infosheets, each available in several languages:

In August 2018, EU-OSHA launched a new database on practical tools and guidance on dangerous substances, with links to key resources and audiovisual tools. The database includes several new case studies created for the current Healthy Workplaces Campaign, providing “real-life examples of good practice in dealing with dangerous substances.”


Israeli Authority Revises Water Treatment Regulation: The Ministry of Industry, Trade and Labor (MOITAL) has revised Part 12 of its Mandatory Standard SI 5438, addressing the use of calcium carbonate to treat drinking water intended for human consumption. The revision, still in Draft status, proposes to adopt the European Standard EN 1018:2013 and Amendment 1: March 2015, with the following changes to protect human health and safety: Adds new references to the normative references appearing in paragraph 2; Removes the column dealing with Type B from Table 3 of paragraph 5.4 dealing with chemical parameters; Adds new test methods to paragraph 6.2; Adds to paragraph 7, which addresses labelling, transportation and storage, a new reference to Israel’s Transportation Regulations; and changes the marking requirements for calcium carbonate described in paragraph 7.4. At present, there is no proposed date for entry into force.

Draft Revision Of Dangerous Substances And Mixtures Standard Amended: Israel has amended and replaced its draft revision of the 2013 Mandatory Standard SI 2302 Part I (SI 2302), titled “Dangerous Substances and Mixtures: Classification, Labelling, Marking and Packaging.” The replacement draft revision is generally based on European Regulation (EC) No. 1272/2008, which itself is based upon the United Nations (UN) document “Globally Harmonized System of Classification and Labelling of Chemicals (GHS).”

The major changes comprising the amended draft revision are:

  • The R and S phrases have been replaced by Hazard Statements (H) and Precautionary Statements (P); and
  • There are no longer separate requirements for domestic and non-domestic uses of dangerous substances.

SI 2302 and the amended draft revision will both apply for a three-year period from the date the revision enters into force. This date is still to-be-determined, but the final date for comments to be submitted is October 27, 2018.


Mexican Authority Updates Food And Beverages Additives Lists: The Comisión Federal para la Protección contra el Riesgo Sanitario (Commission for the Protection Against Sanitary Risk; COFEPRIS) within the Ministerio de Salud (Ministry of Health) has issued updates to Annexes I, II, and III of its Acuerdo Por el que se Determinan las Sustancias Permitidas Como Aditivos y Coadyuvantes en Alimentos, Bebidas y Suplementos Alimenticios, Su Uso y Disposiciones Sanitarias (Agreement By Which Allowed Substances are Determined as Additives and Coadjuvants in Food, Beverages and Food Supplements, Their Use and Sanitary Provisions). Among the updates are additives of several functional classes and additives as colorants.


OECD Requires Implementation Of GHS In Its Member Countries: OECD has recently made it mandatory for its 36 Member countries, as well as those working toward membership, to implement GHS as part of a larger Act designed to reduce the risk from chemical substances. The “Decision-Recommendation of the Council on the Co-operative Investigation and Risk Reduction of Chemicals,” adopted on May 24, 2018, also requires Member countries to establish or strengthen programs designed to reduce the risks posed by existing hazardous chemicals. A specific timeframe for implementation by the Member countries has not been provided.


Greener UK Raises “No Deal” Brexit Concerns: Greener UK, a coalition of major environmental organizations working on Brexit, issued a statement entitled “Environment faces ‘multiple risks’ from a no deal Brexit.” In its statement, Greener UK “[warns] against the potentially harmful impact of a ‘chaotic no deal’ on the environment.” Greener UK refers in the statement to its more detailed paper entitled “What would a no deal Brexit mean for the environment?,” and states that a no deal Brexit is likely to have a damaging impact on areas from “climate to chemicals.” Greener UK further states that a no deal Brexit raises significant fears of harm to nature, animal welfare, human wellbeing, and accountability.

Greener UK projects that, in the agriculture sector, a no deal departure of the UK from the EU would allow trade deals to “force the import of goods produced to lower standards than those in the UK.” Greener UK provides this could undercut domestic producers and increase pressure to “water down British standards.” Greener UK states it is likely that failure to reach a UK-EU customs deal would lead to a hard border in Ireland. Greener UK states “[t]his could lead to delays in border crossings and potentially [jeopardize] the welfare of the 800,000 pigs and lambs that currently cross the border each year.”

Regarding chemicals, Greener UK suggests that the UK leaving ECHA abruptly could threaten the environment and business. Greener UK highlights costs for “a business to re-register chemicals in the EU,” and states that chemicals banned in Europe could find their way to the UK if domestic legislation does not keep pace. Greener UK suggests it is “highly unlikely” that the UK will be able to replicate the EU’s existing chemicals regime, “often considered the gold standard for chemical regulation.”

Greener UK states “a no deal Brexit raises questions about accountability.” Greener UK states that environmental laws and protections are currently upheld by the EC and European Court of Justice, with the UK government “planning to replace their role with a domestic ‘green watchdog’ before exit day.” Greener UK emphasizes that “should the UK leave without a deal and the transition period be [canceled], the new body will not be ready in time and there will be no independent legal authority to hold the UK government and public authorities to account.”

Shaun Spiers, Chair of Greener UK, stated:

A no deal Brexit is becoming more likely by the day. The EU is preparing for it and some backbench [Members of Parliament] seem to welcome the prospect. But make no mistake, there can be no green Brexit if the UK crashes out of the EU without a deal.

There are multiple risks of harm in the event of no deal, including lower environmental standards, poor food safety, and a reduced ability to tackle climate change. For the environment, no deal is the worst possible outcome of Brexit.


Vietnam Announces National Chemical Database System: On August 2, 2018, the Ministry of Industry and Trade (MOIT) announced the availability of the National Chemical Database System. The National Chemical Database System will:

  • Support the management of administrative procedures on chemical management;
  • Share management information between MOIT’s Department of Chemicals and the Departments of Industry and Trade in the field of chemicals;
  • Synthesize and process statistical data for chemical risk assessment and other management needs;
  • Share information on hazardous properties and the classification of chemicals for businesses and communities; and
  • Prepare data to support the provision of information in response to chemical incidents.