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In September 2020, the Ukrainian government published a draft resolution of changes to the Ukrainian Technical regulation on Toy’s safety. The changes in the Technical Regulation are prepared to bring the provisions of the Technical Regulation i
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With Brexit being implemented, The UK has formally left the EU on 31st January 2020 with a withdrawal deal and has now gone into an 11-month transition period which is most likely to end on 31st December 2020. The negotiations between the UK and the
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We are delighted to announce that Sustainability Support Services (SSS) Europe AB has recently changed its registered name to Global Product Compliance (GPC)Europe AB as part of the recent acquisition by the Global Regulatory Compliance Holding. T
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We are excited to share important news regarding the evolution of our company and if this change will affect any of your on-going or future activities with us. We are delighted to announce that our company has recently changed its registered name
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In the context of the COVID-19 pandemic, European states are encouraged to apply derogations to the normal product authorisation requirements of the Biocidal Products Regulation (BPR)
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11th – 12th November, 2020 | Koelnmesse, Germany. Chemspec Europe, which is Europe’s major sourcing and networking event for fine and speciality
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Ministry of Agriculture and Forestry has announced a new draft regulation regarding pesticides on food of plant or animal origin, adapted from European regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on m
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Turkey’s REACH-like regulation KKDIK, adapted from EU REACH as a European adaptation policy, is yet in the first phase – pre-registration phase as known. There have been queries from many organizations regarding the chance of having a late-pre-re
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In a private and recent communication from June 2020, the Health and Safety Executive (HSE) has communicated to GPC (Europe) AB that during this transition period, the UK will remain within the EU-REACH regulatory framework and the UK businesses need
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Taiwan’s Environmental Protection Administration (EPA) has amended its chemical control law ‘Toxic Chemical Substances Control Act (TCSCA)’ and renamed it 'Toxic Chemicals and Concerned Substances Control Act (TCCSCA).' This regulatio
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With Brexit being implemented from 31st January 2020, the UK has formally left the EU with a withdrawal deal and it is currently into an 11-month transition period. The UK is no longer a member state of the EU and until the end of the transition p
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GPC is delighted bringing to you our October Newsletter with a summary of toy regulatory updates around the world and other chemical compliance news.  Toys, both imported and locally manufactured, constitute a significant market for many cou
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Australia issued new legislation for toys containing magnets,” Consumer Goods (Toys Containing Magnets) Safety Standard 2020.” This new legislation will repeal the existing “Consumer Product Safety Standard for Children’s Toys Containing Magn
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With Brexit being implemented from 31st January 2020, the UK has formally left the EU with a withdrawal deal and it is currently into an 11-month transition period. The UK is no longer a member state of the EU and until the end of the transition pe
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On October 14 the European Commission published the comprehensive Chemical strategy (EU Chemicals Strategy for Sustainability). The Strategy is the first step toward a zero pollution ambition outlined in the European Green Deal. The strategy covers
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FCMs regulations are fast-moving to improve the protection of public health. Food contact materials (FCMs) refer to all materials and articles intended to come into contact with food, for example, packaging and containers, machinery to process fo
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  The UK will exit the transition period on December 31, 2020.  From 2021, the EU REACH Regulation will be brought into UK law under the European Union (Withdrawal) Act 2018 and this chemical regulation is also known as UK REACH. REACH, and
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The recent MSDS amendment in South Korea was enforced on 16 January 2021. This amendment requires chemical manufacturers and importers to deliver and submit an MSDS to the competent authority (Korean Occupational Safety and Health Agency, KOSHA
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The European Commission announced the EU Chemicals Strategy for Sustainability on 14th October 2020, as a key commitment policy to the European Green Deal. The ambition of the European Green Deal is to ensure climate neutrality and circular econo
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The Ministry of Health and Welfare in Taiwan circulated a list of Prohibited ingredients in Cosmetic Products on 3 December 2020. After 60 days of publication consultation, the list is now expected to come into force on 1 July 2021. Cosmetic prod
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The Ministry for Development of Economy, Trade and Agriculture of Ukraine has notified the draft resolution, On Approval of the Technical Regulation on Safety of Chemical Products, to the WTO. This draft resolution lists out requirements for registra
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In the context of the authorization process, Member States Competent Authorities and/or the European Chemicals Agency (ECHA), on request of the European Commission, could prepare Annex XV dossiers for the identification of Substances of Very High
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The European Chemicals Agency (ECHA), on behalf of the European Commission (EC), is running its fifth project under the Instrument for Pre-Accession Assistance (IPA). These projects are targeted at assisting European Union (EU) candidate countrie
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On April 14, 2021, ECHA recommends for the European Commission to add seven substances to the Authorisation List (Annex XIV of REACH). Once on the list, companies will need to apply for authorisation to continue using them. The seven substance
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Colombia incorporated GHS guidelines in 2018 based on the Decreto 1.496/2018. The regulation provides guidance for ministries to implement the standard in each sector. In 2021, the Ministry of Labor is the first sector to adopt GHS under Resol
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As convenient as single-use plastic seems to be, the challenges and adverse effects far outweigh its benefits. One of such is that 80 to 85% of marine litter in the EU is plastic material.    On the 31st of May 2021, the European
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A Global NGO network, International Pollutants Elimination Network (IPEN), based on its research, has found levels of Persistent Organic Pollutants (POPs) in almost all the free-range chicken eggs it collected near plastic waste disposal sites in 14
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REACH (EC 1907/2006) is a regulation aimed at improving the protection of human health and the environment through a better and earlier identification of the intrinsic properties of chemical substances. (Source: EC) The EC clarification and amendm
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ECHA added new updates in the Guidance on Registration in August 2021. The new updated version of the guidance document offers advanced support to the companies with their registration obligations.  The Guidance on Registration was first pu
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On the 5th of  August, the Government of Canada nominated long-chain PFCAs, their salts and related compounds (also known as precursors) for consideration under the Stockholm Convention on Persistent Organic Pollutants (POPs). The Stockholm Conventi
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The Ministry of Health, Turkey published on their webiste the draft regulation on the amendment of Turkish Biocidal Product Regulation.  Current Biocidal regulation came into force on 31.12.2009 in Turkey. The regulation aims to assess the effe
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The European Chemical Agency (ECHA) announced the SCIP Database in September 2021; this is a public database for Substances of Very High Concern (SVHC) in EU products. SCIP database is aimed at helping consumers make informed purchasing choice
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On the 28th of October 2021, the European Commission adopted the proposal on protecting human health and the environment by tightening the limits for POPs. Persistent Organic Pollutants (POPs) are the most harmful chemicals in waste, and the proposal
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The European Commission adopted its new Circular Economy Action Plan (COM/2020/98 final) in March 2020.  The plan – which is one of the first deliverables under the European Green Deal (COM/2019/640 final) – lays out more in detai
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The European Commission published a Regulation amending several annexes of the cosmetics regulation, prohibiting certain substances from use in cosmetics. This regulation was published on the 3rd of November and came into effect on November 23, 20 da
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On the 16th of December 2021, the commission confirmed that the exemption for mercury in linear fluorescent (LFL) lamps and single capped (compact) fluorescent lamps will be revoked. This is because the uses of mercury can be sufficiently substitute
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On the 11th of January 2022, the European Commission granted a temporary exemption for the use of lead in the following electronic materials: bismuth strontium calcium copper oxide superconductor cables wires and lead in their electrical co
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In December 2021, the European Commission adopted the proposal of a new EU Directive aimed at reducing environmental crime. This proposal defines new environmental crimes, obliges Member States to take criminal law measures and sets the minimum level
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European Union (EU)  A new Chemicals Strategy for Sustainability was presented by the EU in 2020 as part of the EU Green Deal. This year, there are major implementations that will be made to achieve this strategy as Europe transitions to a toxi
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Under EU Cosmetics Regulation, the commission banned some uses of methyl-n-methylanthranilate as a fragrance ingredient. This is an ingredient usually used in the production of shampoos, soaps, and other beauty products. In alignment with the initi
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The European Commission, after a serious struggle, recently declared resorcinol as an SVHC. This decision was made based on the endocrine-disrupting properties of human health. This decision was made by a voting process where 19 member states vote
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In January 2022, Cosmetic Alliance (CA) and a representative from their allied stakeholder coalition met with Health Canada (HC) officials to discuss the ban of cosmetics testing on animals in Canada. HC is currently working on publishing a policy
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On the 23rd of February 2022, the REACH Annex XV restriction dossier was published addressing PFASs’ risks in firefighting foams to human health and the environment. The European Chemicals Agency (ECHA) proposes an EU-wide restriction on all per
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European Commission publishes 12 delegated acts to end the exemptions for the use of mercury in lamps. These lamps include general-purpose compact (CFL) and linear fluorescent (LFL) lamps. Considering the wide availability of mercury-free altern
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Australia Competition and Consumer Commission (ACCC) reviews the voluntary Australian standard and proposes a new compulsory safety standard on February 25, 2022. This new rule mandates suppliers’ compliance to the newest standard called Austral
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On the 7th of March 2022, the EU notifies the decision to not approve N-(3-aminopropyl)-N-dodecylpropane1,3-diamine as an existing active substance for use in biocidal products. This decision was made due to the human health risks posed by the sub
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On March 4, 2022, Sweden proposes to ECHA to identify N-(hydroxymethyl)acrylamide (with CAS No 924-42-5) in the list of Substances of Very High Concern (SVHC). SVHC list consists of substances considered to have serious effects on human health an
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On March 11, 2022, the commission announces its decision of a biocidal product in line with Regulation (EU) No 528/2012 of the European Parliament and of the Council. A product that contains capsicum oleoresin expeller pressed to be used as a rep
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On March 22, 2022, the European Commission held its second stakeholders’ workshop on “Safe and Sustainable by design (SSbD) criteria for chemicals and materials”. The development of criteria to assess the safety and sustainability of chemical s
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The EU has announced that the ban on Per- and Polyfluoroalkyl Substances (PFASs) will not include the essential use criteria. This is because the essential use criteria will not be ready at the right time for the restriction proposal. The essential c
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The European Commission recently added five SVHCs to the authorisation list, REACH Annex XIV due to their reprotoxic, carcinogenic or endocrine-disrupting properties.  These substances include: tetraethyl lead, 4,4'-bis(dimethylamino)
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On the 29th of March 2022, the European Commission opened a public consultation for the Cosmetic Products Regulation (Regulation (EC) No 1223/2009). The objective of this revision is to ensure human health and improve the functioning of the inter
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In March, the European Commission adopted REACH authorization decisions for the use of four chemicals that are listed in Annex XIV of the law. CTPht is on the REACH authorization list for its carcinogenic, persistent, bioaccumulative and toxic (P
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The European Commission published, on April 25, 2022, a list of substances and substance groups for which restrictions under the REACH Regulation are being proposed, prepared, or considered.   One of the lines of action under the European Uni
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Opposition against the proposed draft changes on ECHA’s intermediates guidance from the German industry body has been strongly expressed. Their claim was that the modified original proposal defies a 2017 court ruling. This modification made earlier
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On May 3, 2022, the European Parliament voted on a European Commission proposal to tighten the limits for the presence of Persistent Organic Pollutants (POPs) in waste. The proposal was earlier adopted by the European Commission. The presence of P
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A leading European research institute, Oeko-Institut opened a consultation to exempt lead restriction under the EU RoHS Directive for medical devices’ production. The expectation is to develop lead-free alternatives, which have been delayed due to
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On May 2, 2022, the European Union released a draft to amend Annex XVII to Regulation (EC) No 1907/2006. The new amendment mainly concerns articles in which production includes the use of formaldehyde or formaldehyde-releasing substances that release
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Exports and products involved with perfluorooctanoic acid (PFOA), its salt forms, and PFOA-related compounds are banned after the European Commission makes addition to Annex V of the Prior Informed Consent (PIC) Regulation. Echoing the Stockholm Conv
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The European Chemicals Agency (ECHA), together with the Member States reviewed a group of 148 bisphenols, of which 38 bisphenols have potential reprotoxic or hormonal effects. Bisphenols are commonly known as endocrine disrupters for human health
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The European Commission updates the glossary of ingredient names commonly used in cosmetics production. This was done to correct the names of ingredients that were written incorrectly while some were updated to comply with the recent changes made in
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The European Chemicals Agency (ECHA) and the European Food and Safety Authority (EFSA) announced on May 10, 2022, that an ongoing assessment of the health and environmental risks of glyphosate will be delayed. Glyphosate-based herbicides are the most
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Recently, the opinions of the Committee for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) were made available publicly on the ECHA website for undecafluorohexanoic acid (PFHxA). An initial proposal was made by Germany to set restrictions f
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The European Commission on June 1, 2022, announced its proposal to approve didecyldimethylammonium chloride (DDAC) as an active substance for use in biocidal products of product-types 1 and 2. It was proposed under the Biocidal Products Regulation (B
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On June 8, 2022, the European Commission published a proposal on Polyvinyl chloride (PVC) articles that contain lead and lead compounds. The draft proposal amends Annex XVII, specifically entry 63, prohibiting the use of lead and lead compounds in PV
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The International Council of Chemical Associations (ICCA) has announced a new four-year pilot project between four African countries. These four African countries, Cote d’Ivoire, Ghana, Kenya, and Nigeria collaborated to start a project that will
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With the purpose to facilitate the “One substance, one assessment" process, the European Commission plans to review and improve the current way of how chemicals’ required data are gathered and disseminated under different EU laws. This proposal i
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On the 10th of June 2022, ECHA added an entry on n-(hydroxymethyl)acrylamide (NMA) to the REACH candidate list. This addition was done due to the carcinogenic and genotoxic properties of the chemical, posing possible threats to cause cancer or geneti
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ECHA’s Committee for Risk Assessment (RAC) has expressed its support for restricting the use of lead in ammunition for hunting, outdoor sports shooting, and fishing by adopting its opinion on ECHA’s proposal to restrict the use of lead for releva
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On the 15th of June 2022, the European Commission notified its draft decision to not approve methylene dithiocyanate as an existing active substance to be used in biocidal products of product-type 12. This is in accordance with Regulation (EU) No 528
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The European Commission plans to put a stop to the REACH restriction procedure for cobalt salts while focusing on setting occupational exposure limits (OELs) for the compound. This decision follows a debate on how best to manage risks for the compoun
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The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) consults on its opinion regarding the safety of titanium dioxide in toys until July 4, 2022. Considering the classification of titanium dioxide i
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The European Commission opens consultation till July 8, 2022, on the exemption of hexavalent chromium usage. According to the proposal, the exemption of the use of hexavalent chromium as an anticorrosion agent in gas absorption heat pumps (GAHPs) wil
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On June 22, 2022, the European Parliament and Council reached an agreement on a proposal by the European Commission to review Annexes IV and V of Regulation (EU) 2019/1021, on persistent organic pollutants (POPs). The allowable limits were discussed
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On 10 June 2022, the European Commission released a new recommendation updating the definition of nanomaterials that should inform EU legislation on the topic. A deliverable of the EU Chemicals Strategy for Sustainability, this new recommendation upd
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On June 22, 2022, the European Parliament adopted its negotiating position on the European Commission’s proposal for a regulation establishing a Carbon Border Adjustment Mechanism (CBAM). In the EU, certain industrial sectors must purchase the
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Chemspec Europe’s 35th International Exhibition for fine and specialty chemicals industry will take place from May 31 to June 1, 2022, in Messe Frankfurt, Germany. This is Europe’s major sourcing and networking event for the chemical indust
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Welcome to our webinar on "Comply with UK-REACH: How can companies prepare" organized by Global Product Compliance(GPC) and Indian Chemical Council(ICC). The EU REACH Regulation was brought into the UK law on 1 January 2021, and this is known as U
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European Unions (EU) Registration, Evaluation, Authorization (Restriction) of Chemicals (REACH) Regulation Background : REACH is a regulation of the European Union, adopted to improve the protection of human health and environment from the risk
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REACH will be governed by a nodal agency known as European Chemical Agency (ECHA). ECHA is the driving force among regulatory authorities in implementing the EU's ground-breaking chemicals legislation for the benefit of human health and the environm
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REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies need to register their substances and to do this they need to work together with other companies who are registering the same
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The total registration costs mainly consist of three parts: Data fees paid to lead registrant or Consortium to purchase letter of access to refer to the common parts of registration dossier. The fee is tonnage dependent. Data fee v
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Cosmetics Directive - The Directive 76/768/EC has been governing the composition, labelling and packaging of finished cosmetic products in the European Union since 1976 and is now replaced by the Cosmetics Regulation (EC) 1223/2009. Cosmetics Regu
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Regulation (EC) No 1272/2008 states that it applies to all substances and mixtures supplied in the European Community except where other community legislation “lays down more specific rules on classification and labelling”. The labelling of c
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Scope Regulation (EC) 1223/2009 on cosmetic products covers cosmetics defined as: Any substance or mixture, Intended to be placed in contact with The external parts of the human body (epidermis, hair system, nails, lips and external genital
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A list of Competent Authorities for every Member State may be found here Regulation (EC) 1223/2009 is enforced by a “Competent authority” in each member state, Each member state their own authority and enforcement Each Manufacturer/Distribu
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The competent authorities of the Member States shall cooperate with each other and with the Commission to ensure proper application and due enforcement of this Regulation and shall transmit to each other, all information necessary with a view to appl
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Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the information to the commission on the online portal i.e., Cosmetic product Notification Portal. Only one notification is necessary to
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The UK has formally left the EU at 23:00 GMT on 31st January 2020 with a Withdrawal deal. This has only marked the next step in the Brexit process. Post-Brexit, the UK has now entered a transition period until 31st December 2020 (also known as the
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UK REACH - What needs to be done? Post transition period, the EU REACH Regulation will be brought into UK law by the European Union (Withdrawal) Act 2018. This Regulation, and related legislation, will be retained in the UK with the changes necess
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Switzerland is not a member of the EU or the European Economic Area (EEA) and all new substances must be notified, registered and/or declared in Switzerland before they are placed on the market. This is so even if they are already registered in the E
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A new substance is defined a substance that is not listed on EINECS (European Inventory of Existing Commercial Chemical Substances). This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and
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1. Did the EU ban Single-use plastics? Yes, the EU has banned single-use plastic products to reduce the danger these non-recyclable products pose to our environment. 2. What is the new EU Single-use Plastic Directive about? The new EU Single
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Single-Use Plastics Directive (SUPD) On the 31st of May 2021, the European Commission released a new directive on single-use Plastics. The new EU Single-Use Plastic Directive aims to make further clarifications about plastic products that fall
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The regulation of medical devices is primarily concerned with enabling patient access to high quality, safe and effective medical devices, and avoiding access to products that are unsafe. When appropriately implemented, regulation ensures public heal
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The regulation of medical devices is primarily concerned with enabling patient access to high quality, safe and effective medical devices, and avoiding access to products that are unsafe. WHO has a mandate, as outlined in the World Health Assembly (W
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Chemicals Strategy for Sustainability  The European Commission presented its Chemicals Strategy for Sustainability in October 2020, with an overarching goal of eliminating or minimizing the use of hazardous substances. This is expected to bring pos
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Chemicals Strategy for Sustainability The European Commission presented its Chemicals Strategy for Sustainability in October 2020, with an overarching goal of eliminating or minimizing the use of hazardous substances. This is expected to bring posit
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The European Medical Devices Regulation (MDR) replaced the previous Medical Device Directive (MEDDEV), which was lagging the current state of the art. The MDR will be:  Introduced progressively  Updated regularly by means of Implementi
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A notified body is an organization designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislat
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EU Regulation1107/2009 established the plant protection industry. Plant protection products (PPPs) in the European Union under Regulation (EC) No 1107/2009 Data requirements have increased, and risk assessment schemes have become more complex. The Eu
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Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and
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EU Regulation1107/2009 established the plant protection industry. Plant protection products (PPPs) in the European Union under Regulation (EC) No 1107/2009 Data requirements have increased, and risk assessment schemes have become more complex. The Eu
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Following provisional clearance for limited use, the pesticide registration procedure begins with two years of testing and inquiry. An advisory committee comprised of representatives from several ministries, including Environmental Protection, Health
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To get approval of an active substance at the EU level,  An applicant must select a Member State (MS) that will act as the Rapporteur Member State (RMS) for the active substance.   When the chosen MS agrees to do the evaluation, the a
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All the substances used in making plant protection products have been audited regularly by the audit team of both the member state and the Commission. Rules and Regulations are dynamic and keep on evolving with rapid growth in scientific and technolo
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Mercosur i.e. the common market of the south, is the largest trading blocking South America. It comprises Argentina, Brazil, Paraguay, Uruguay and Venezuela. Its associate countries include Bolivia, Chile, Colombia, Ecuador, Guyana, Peru and Surin
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The basic Framework in the Mercosur countries closely resembles the Food Contact Material and Articles regulations to that of the European Union and to some measures of the US-FDA. MERCOSUR's executive body is the Common Market Group. It is comp
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FCM
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Community legislation on FCM covers the following: - 1. Materials already in contact (packaging of prepacked food) 2. Materials intended to come in contact with food (cups, utensils) 3. Materials expected to come in contact (table top, refrigerato
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Circular Economic aims to Reduce Waste by keeping the products in use, which signifies each product's importance. The circular economy seeks to make the most of the material resources available by applying three basic principles: reuse, reduce, a
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The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH, 2018) is an EU regulation created to protect human health and the environment from the risks posed by chemicals. REACH applies to substances on the nanoscale according t
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Special considerations for a set of tests and standards have been stated based on EU legislation for food-related nanotechnology applications (ESFA, 2011). Another aspect of nanomaterial’s regulation is the economic parameters for using nanotechn
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The main regulatory framework for cosmetics in the EU is EU Regulation 1223/2009. Based on this structure, a list of all NMs used in cosmetics should be available to all consumers. Most recently (i.e., October 2019), the EU updated the existing guida
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In May 2012, the Regulation on the marketing and use of biocidal products was enacted. The European Chemicals Agency oversees the biocidal product authorization procedure. The definition of the word "nanomaterial" provided by the European Commission
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The EU is a party to the United Nations Economic Commission for Europe (UNECE) Air Convention (renamed in 2020; previously the UNECE Convention on Long-Range Transboundary Air Pollution (CLRTAP)). The Air Convention’s 1998 Aarhus Protocol on Persis
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Producers and importers of hazardous substances and mixtures to the Norwegian market have to follow the Regulations on declaration of chemicals to the product register (declaration regulations), enforced on June 1, 2015. Applicants need to submit in
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Toys, both imported and locally manufactured, constitute a significant market for many countries. Over the past decides, many countries have adopted toy safety regulations or reinforced their current regulatory framework. The United States adopted th
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The European Union's Cosmetics Directive regulation requires that cosmetics products placed on the EU market be safe; that is, they "must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use." As
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EU cosmetics regulation 1223/2009 provides a definition of the cosmetic products in the EU: “‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, n
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Yes, the requirement applies to all cosmetics as defined under Article 2 of the Cosmetics Regulation.
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Yes, it applies to all existing products still placed on the market as of 11 July 2013 and all new products subsequently placed on the market [Article 11(1) & 11(4)]. It does not apply to products still on shelves, but no longer being placed on the m
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Responsible person can be any legal or natural person who is based within the EU. Therefore, if the manufacturer is from the EU, they usually act as the RP themselves. Cosmetics manufacturers from outside of the EU, on the other hand, can’t act as
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Each product placed on the EU market needs to have a responsible person assigned. The regulation established this obligation by saying: “Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible
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CPSR stands for “cosmetic product safety report”. Cosmetic product safety report content is described in Annex I of the EU cosmetics regulation 1223/2009. It consists of 2 parts: cosmetic product safety information and cosmetic product safety ass
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Responsible person (RP) is a legal or a natural person, who has to be established within the EU. The primary task of the RP is to ensure compliance of the cosmetic product placed on the market with the EU cosmetics regulation.
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There is phase-in, non-phase-in concept in this regulation. If a cosmetic product is placing first time in the market has to be notified and complied under this regulation by every Responsible person.
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You do not need to relabel your mixtures if they were notified under national schemes as the notification remains valid until 1 January 2025, unless you need to make an update. When you are required to submit information according to Annex VIII (i.e.
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