People say that a picture says a thousand words. How much more do movies say? But how can a film cover the complex topic of regulatory chemical compliance? And how could anyone develop a meaningful plot based on it?
Regulatory chemical compliance appeals to our desire for safety and security, so it also deals with trust. Customers and users want trustworthiness and transparency. They want to be sure that a product actually contains what the label indicates and that the label indicates what a product actually contains– and they want to do both seamlessly. Those who take that to heart will have fans on their side. In short: Brands that want to be seen as likeable and reputable should at least do what the law requires.
But enough with the words: Let the pictures speak!
The EU Commission has published a draft modification of Annex XVII of REACH and defined new threshold values for 33 carcinogenic, mutagenic and reprotoxic (CMR) substances used in clothing, textiles, and footwear. When concentrations of the substances exceed the thresholds, they cannot be marketed in the EU.
Sections 7, 8, and 9 of the draft specify products exempted from the regulation, such as natural leather products, carpets, and protective equipment. Annex XVII lists the new thresholds. The regulation takes effect 20 days after its publication in the Official Journal of the European Union.
The EU has issued a press release on the changes. Please see our blog entry: Textiles: New Restrictions on CMR Substances.
We are ready to advise you about what you need to note and what measures you need to take in regard to a prohibited substance. Contact us at email@example.com.
Posted in REACH
Tagged CMR, EU, REACH
The REACH-En-Force (REF 5) monitoring project, aimed at improving the quality of safety data sheets (SDS), is entering a decisive phase. Its members will meet at the beginning of October to work out an overview of the problems with SDSs and advise about the appropriate countermeasures. In preparation for the meeting, inspectors from 28 EU countries examined the completeness and accuracy of SDSs and exposure scenarios. They then collected the results in a database.
According to a report from ChemicalWatch, Sinead McMickan, the vice chair of the REACH-EN-Force-Forum, criticized the quality of SDSs even before the meeting. At the Chemical Watch Enforcement Summit Europe 2018 at the end of September, she stated that the quality of the SDS was worrisomely poor. The final results are to be presented in November.
Meanwhile, the ECHA has published a new guideline for SDSs and exposure scenarios. It is available in 23 languages and can be downloaded free of charge from the EU Bookshop.
We can create safety data sheets in almost all country versions. If you have any questions, please contact us at firstname.lastname@example.org.
Posted in SDS
Tagged ECHA, REACH, SDS
At their 14th meeting, held in Rome in mid-September, members of the committee of the Rotterdam Convention of the United Nations suggested including the industrial chemicals hexabromocyclododecane (HBCD); perfluorooctanoic acid (PFOA), its salts, and all PFOA-related compounds; and pesticides phorate and acetochlor in Annex III of the Rotterdam Convention. All the chemicals on this list are subject to the prior informed consent (PIC) procedure.
According to the procedure, companies can import the hazardous chemicals listed in the Annex only after the member state involved has already been informed about the properties of the chemicals and their associated risks. The member state must expressly agree to the import. The EU hopes that the procedure serves as a control function. The importing states are often developing or emerging nations that have little or no capacity to evaluate and monitor chemicals.
The next meeting of the Conference of the Parties, to be held in Geneva from April 29 to May 10, 2019, will decide on the inclusion of the chemicals noted above in the list.
The Rotterdam Convention is the first international treaty on the import and export of chemicals. It was initiated in Rotterdam on September 10, 1998 and went into force on February 24, 2004. Currently,160 countries have ratified the Convention.
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Posted in SDS
Tagged PIC, SDS
A majority of the members of the EU Parliament has called for measures against the use of hazardous substances in products because such use makes recycling difficult or even impossible. That’s why they should disappear from the supply chain as quickly as possible. The members strongly support a Resolution that calls for active measures and supports the position taken by the EU Council of Ministers, The EU Commission, and the ECHA.
According to the Resolution, the first task is to trace substances of concern in the supply chain, particularly in imported products. Waste and chemicals policies must be aligned with each other and avoiding them should take priority over recycling. However, current legal regulations do not support this goal. That’s why regulatory gaps must be closed as quickly as possible, particularly for imported articles. Companies should be mandated to replace toxic substances in products and supply chains consistently.
The Resolution sketches a path for how things could look concretely. Transparency should be improved in the first step. That step requires modifying Article 9 of the Waste Framework Directive so that in the future, vendors would have to inform the ECHA of the presence of such substances.
The Resolution covers four key factors and options for action:
1. Insufficient information on substances of concern in products and waste.
- Substances of concern identified in REACH as SVHCs, prohibited by the Stockholm Convention (POPs), specific substances restricted in articles listed in Annex XVII of REACH, and specific substances subject to particular legislation (Option 1A).
- All substances of concern should be tracked “as soon as possible” (Option 2A) and information should be made available to all those in the supply chain, recyclers, and the public.
- All imported products are to be tracked, and “deeper collaboration” at the international level is required.
- The ECHA must ensure that chemicals with incomplete or incorrect REACH registration dossiers do not come to market.
2. A reduction in the amount of substances of concern in recycled materials.
- Whether products are manufactured from primary or secondary materials, they should be subject to the same rules to protect human health and the environment.
- Products that contain recycled substances may be managed only in secure registration, tracking, and disposal systems.
- No competitive disadvantage may exist between products manufactured in the EU and those that are imported.
- When determining the requirements for substitute chemicals, REACH and other productspecific law and regulations should be considered.
- It would be advisable to introduce a product passport to disclose all the substances present in products.
3. Uncertainties about when the Waste Framework Directive applies and when it does not.
- Clear, EU-wide rules must be defined to determine when the Directive applies and when it does not.
- The waste definitions in the Waste Framework Directive must be aligned at the EU level.
4. Difficulties in the waste classification methodologies that create uncertainties in the recyclability of materials.
- The rules for classifying waste as hazardous should be consistent with those of the CLP regulation.
- The EU Commission should clarify the correct interpretation of the CLP regulation to prevent incorrect classification of waste containing substances of concern.
- The lack of enforcement of EU waste legislation is “unacceptable” and must be improved.
We can support your compliance with all legal requirements when dealing with products containing substances that can be harmful to health. Please contact us at firstname.lastname@example.org.
Posted in CLP, REACH
Tagged CLP, ECHA, REACH
Germany has submitted a proposal for harmonization of the classification and labeling (CLH) of bisphenol A (BPA) to the ECHA as part of the CLP Regulation. The supplemental entries are stored in the Registry of Intention, a database containing information on the classification and labeling of declared and registered chemicals.
Germany classifies BPA into the following individual hazard classes:
- Serious eye damage, category 1
- Skin sensitization, category 1 – can cause an allergic reaction
- Reprotoxicity, category 1B – may damage fertility
- Specific target organ toxicity (single exposure), category 3 – can cause respiratory irritation
- Aquatic acute, category 1 and M-factor 1 – very toxic to aquatic life
- Aquatic chronic, category 1 and M-factor 10 – very toxic to aquatic life with long-lasting effects
BPA is counted among substances of very high concern (SVHC) and appears on the REACH candidate list. The substance is considered toxic to reproduction, affects the hormonal system, and has other negative properties.
BPA is used in the food industry for the inner linings of cans and lids and in plastic packaging. A current proposed law of the EU Commission seeks to lower the present migration limits for BPA in materials that come into contact with food – from 0.6 mg to 0.05 mg/kg. Simultaneously, a new working group of the European Food and Safety Authority, consisting of scientific experts, began evaluating the newest toxicological data on BPA in September 2018. The German Federal Institute for Risk Assessment (BfR) also provides an overview of Q&A on BPA.
Be attentive to the safe use of your products. If you have any questions, please contact us for answers and advice at email@example.com.
Posted in CLP, REACH
Tagged BPA, ECHA, EU
The ECHA has updated its Web site on poison centers and is offering new support services that simplify the preparation and transmission of information on hazardous mixtures. See the press release issued by the ECHA.
The Web site supports companies in complying with the requirements of Annex VIII of the CLP Regulation. The annex requires companies that market hazardous mixtures in the EU to notify the appropriate agencies of their activities.
The new part of the ECHA Web site helps companies answer these kinds of questions:
- What are the submission deadlines and what guidance is available?
- Which mixtures does the rule cover?
- What information must be included on chemical composition, toxicology, and product category?
- What information must companies supply on product labels?
- How can a unique formula identifier (UFI) be created?
The ECHA is currently developing a portal know as Poison Centers Notification (PCN). The Web app should enable companies to create information in the PCN format, which is compatible with UICLID. That would reduce the effort involved in having to transmit information in multiple member states. The agency plans to go live with the portal at the start of 2019. See also the information sheet of the ECHA, How to prepare and submit information to poison centres.
At KFT, we offer companies an emergency number service through our partners Chemtrec and Giftinfor-mationszentrum Nord (GIZ). We would be pleased to provide you with personal information about the details of the service.
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Posted in CLP
Tagged CLP, ECHA
By an overwhelming majority (597 to 15 votes), the European Parliament voted for a ban on microplastics by 2020. In particular, the prohibition applies to microplastic particles used in personal care and cleaning products, ostensibly to improve their cleansing properties. Mark Demesmaeker, a Belgian member of the European Parliament and responsible for the EU strategy on plastic, stated that it is high time for action. See the notice of the EU Parliament.
In January, the EU Commission asked the ECHA to create a restriction dossier in Annex XV of REACH for consumer and commercial products.
In addition, the Commission is considering prohibiting single-use plastics, such as party goods, plates, and balloon sticks and asking companies that package the goods to share the recycling costs. The Parliament will vote on those measures in October.
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