News

January 11, 2024 

We are delighted to announce a momentous collaboration between Global Product Compliance (GPC) and Vipragen Biosciences that marks a pivotal step forward in our pursuit of excellence and strategic expansion. The two industry leaders are uniting to offer unparalleled end-to-end solutions in the fields of regulatory compliance and contract research services across diverse sectors in Europe. By harnessing GPC's regulatory study management and monitoring expertise and Vipragen's research and development capabilities, this collaboration will uniquely bridge the gap, offering unprecedented regulatory compliance and pre-clinical services to the European market.  

Global Product Compliance (GPC) was established in 2008 in Sweden, GPC Group has been providing comprehensive global support and end-to-end compliance services for over 15 years. Operating across 50+ countries, complying with 75+ regulations, and serving 7 sectors, GPC has managed 1000+ regulatory management studies and is committed to excellence in regulatory compliance. 

Vipragen Biosciences is an end-to-end pre-clinical CRO offering Integrated Discovery and Development services to a global clientele. Renowned for its comprehensive suite of services catering to various industries, Vipragen boasts state-of-the-art laboratories with certifications including OECD-GLP, NABL, and AAALAC.

Shisher Kumra, Founder & Chief Executive of GPC, expresses enthusiasm for the joint venture, stating: "We look forward to this promising partnership with Vipragen. Our study management and monitoring expertise is complimented exceptionally by Vipragen’s high-quality contract research experience and together we are set to make the European regulatory compliance process efficient and seamless.” 

Dr. Chandrashekaran S, Chairman and Managing Director of Vipragen Biosciences, comments: "We are thrilled to collaborate with GPC to enhance the global impact of our services. This partnership strengthens our commitment to delivering high-quality solutions while ensuring stringent compliance with evolving regulatory standards."  

GPC and Vipragen are confident that this strategic alliance will not only elevate our capabilities but also significantly contribute to advancing global standards in our respective industries. We are excited about the possibilities that this collaboration brings and look forward to navigating the regulatory landscape and shaping the future together.  

If you have any questions or require further information, please do not hesitate to reach out to us.  

Read more here

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.  

The new name GPC Europe AB will be officially effective from 1st July 2020. Wherein,  

No change is applicable on the  

1. Legal Entity Number 

1. Bank name and Account Number 

1. Management, professional team and contact persons for your organization. 

The changes that would be affected are: 

1. Company Logo       

1. Website changed to gpcgateway.com  

1. Executives email changed to xyz@gpcregulatory.com  

1. LinkedIn page changed to GPC Group.  

Read more here

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 Indian Legal Entity has recently changed its registered name from Nagpur Sustainability Support Services Private Limited (NSSS) to GPC Regulatory India Private Limited (GPC India) as part of the recent acquisition by the Global Regulatory Compliance Holding. The name Global Product Compliance is also an indication of our global presence for supporting your company in different countries/regions for respective chemical regulations.

The new name GPC Regulatory India Private Limited (GPC India) will be officially effective from 1st Oct 2020.

Read more here

We are delighted to announce that Global Product Compliance (GPC) has joined hands with Auxilife Scientific Services Pvt. Ltd. as a part of the recent acquisition by GPC on the 1st of July 2020.

This alliance will strengthen our existing resources and expand our global presence in the agrochemical sector. We will now be able to comprehensively support your aspiration in different countries/regions for agrochemical regulatory compliance.

This teaming up strengthens GPC and Auxilife’s expertise, skills, and global reach across sectors:

• Complete regulatory compliance for plant protection products, biocides, drugs, cosmetics, medical devices, food, and feed additives.
• Team of experts positioned in India and Germany.
• Global agrochemical regulatory compliance support.

Read more here

The RoHS stands for the Restriction of Hazardous Substances, in specific, applies to electrical and electronic equipment (EEE). It aims to prevent pollution in product design, purchase, and production phases by restricting the use of harmful chemicals such as heavy metals, brominated flame retardants, and phthalates in such products. In the EU/EEA, the RoHS prevents the use of certain chemicals in EEEs above a threshold of 1000 ppm and sets out requirements to be applied by manufacturers, importers, and distributors throughout the supply chain.

Despite its undeniably positive impact, the RoHS is facing several challenges. Among these are RoHS’s repeated inconsistencies with REACH, and its inability to tackle the negative effects on human health and the environment of the global increase in E-waste. The increase is especially detrimental for low- and middle-income countries, which are often involved in the informal recycling and landfilling of E-waste. These issues, however, are being addressed: low- and middle-income countries are adopting legislation on E-waste management, and the EU Green New Deal will involve a review of RoHS aimed at enhancing consistency with REACH.

As of 2020, over 45 jurisdictions outside of the European Economic Area (EEA) consider adopting or already introduced RoHS-like regulations. The following sections introduce the RoHS regulation, and its impacts on the electronics industry, a global overview of the RoHS, and current challenges. This month, the Newsletter team at GPC brings to you a Global Overview on the RoHS and to stay updated on how increased concern over environmental and health impacts of electronics boost the RoHS-like regulations around the world.

Please click here to read our report 'A Global Overview on the RoHS'.

Recently in a personal communication with CIS Centre, Russia we got notified that due to the COVID-19 crisis the Russian Inventory Notification Deadline due on 1st May 2020 has been extended 3 more months till 1st August 2020.

Below is the full excerpt of the communication:
On the extension of the deadlines for the submission of information as part of an inventory of chemicals in connection with the spread of COVID-19.

In connection with the transfer of a number of enterprises to remote operation due to the threat of the spread of a new coronavirus infection and in order to provide industry support measures, the Ministry of Industry and Trade of the Russian Federation informs in addition to the letter dated February 17, 2020 No. IM-10702/13 about the extension of the deadlines for submitting information procedures for the inventory of chemicals (including as part of mixtures) in circulation and planned for circulation in the territory of the Russian Federation, until August 1, 2020

With detailed information on the chemical inventory procedure, please familiarize at methodological recommendations http://minpromtorg.gov.ru/common/upload/files/docs/Pismo_EVL_s_metod.rek-mi.pdf ) and on the website of the Association “NP KIC CIS” in the section “Preparation for inventory” (URL: https://ciscenter.org/tabstest/faq.php )

If you are exporting to Eurasian Economic Union (EAEU: Russia, ​Belarus, Kazakhstan, Kyrgyzstan, & Armenia) and has not yet notified your chemical(s) in the Russian Inventory then SSS within its Russian Legal entity can act as a Nominated Representative (located in the EAEU) for your company, and can free of charge submit your chemical(s) notification.

Please submit your CAS details here and for any specific queries reach out to our Regulatory Expert, Ketki Kulkarni at ketki@SSSEurope.onmicrosoft.com.

What happens if you miss this inventory notification deadline?

If your substance is not present in the inventory (notified by someone else) then it will be considered as new and will be subject to the submission of a comprehensive study of the properties with a chemical safety report.

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 to continue to comply with EU REACH in their current roles and in their supply chains. The UK authorities have indicated that, the extent to which the provisions in UK REACH will come into effect at the end of the transition period will largely depend on the outcome of the UK-EU trade deal negotiations. Based on the outcome of negotiations, the authorities might need to change some, or all the provisions and any transitional provisions will give sufficient time span for the companies to comply.

UK-REACH and the UK-REACH IT system ‘Comply with UK-REACH’ are not in operation currently. Guidance on how to register under UK-REACH is being prepared by the authorities. Details of the supporting services available to potential registrants (including account creation) for UK-REACH will be released in due course.

GPC (Europe) AB is in constant touch with relevant UK-REACH bodies and will keep you updated as and when the situation would change and/or there are any new advancements.

If you have any further questions then you can contact our UK-REACH manager Priyanka Manapure at priyanka.m@SSSEurope.onmicrosoft.com.

Taiwan’s Environmental Protection Administration (EPA) has amended its chemical control law ‘Toxic Chemical Substances Control Act (TCSCA)’ and renamed it to Toxic Chemicals and Concerned Substances Control Act (TCCSCA). This regulation has come into force from January 1, 2020. 

Companies that manufacture or import Existing Chemical Substance in an annual amount of 100 kilograms or more need to apply for Phase One Registration within 6 months from the date of exporting. Furthermore, if the chemical in a quantity that is above 1 tonne per year or more and falls under the list of 106 Priority Existing Chemicals (PECs) then companies need to do a Standard Registration. 

In the case of Confidential Business Information (CBI), exporters to Taiwan should communicate with their buyers and register via a Third Party Representative (TPR). 

As a TPR, SSS can communicate in the supply chain on behalf of your company and also assist you with Phase One & Standard Registration. 

If you have any further questions on TCCSCA compliance, please contact our Regulatory Manager Chia-Sui Hsu at chia-sui@SSSEurope.onmicrosoft.com

GPC is delighted to bring you our Newsletter October 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 countries. Over the past decades, many countries have adopted toy safety regulations or reinforced their current regulatory framework. The United States adopted the Consumer Product Safety Improvement Act (CPSIA) in 2008, and the European Union adopted Directive 2009/48/EC on the Safety of Toys in 2009. They were soon followed by the Eurasian Economic Union, which adopted regulation CU TR 008/2011 in 2011. Turkey adopted a regulation based on the EU Directive on Toy Safety in 2016, and India’s Toy Quality Control Order was enacted in early 2020.

In countries where comprehensive toy safety regulations have been adopted, toys are most often subject to a two-tier regulatory framework. First, a legislative act sets out the general obligations placed upon the industry. Public authorities then request an authorised standardisation body to draft detailed safety requirements in the form of standards. For example, the European Union, the United States, and the Eurasian Economic Union all have both a regulation and a set of safety standards.

Regulatory frameworks applicable to toy safety may vary from one jurisdiction to another. They tend, however, to share some common features. Such features typically include a requirement to comply with safety provisions in relation to the toys’ physical, mechanical, electrical, radioactive, flammability-related, and, of course, chemical properties. The latter generally include lists of substances that may not be contained in toys, substances that may be contained under certain concentrations, and migration limits.

Other common features often consist of a requirement for manufacturers to affix warnings, ensure the toys’ traceability, and perform a conformity assessment prior to placing the toys on the market. Conformity assessment may be performed according to various modalities (e.g. self-assessment or third-party assessment) and normally results in the issuance of a declaration of conformity.

• India - BIS Certification for Safety of Toys
• South Korea restrictions on heavy metals and phthalates in Children's products
• Denmark implements EU Directives
• The EU Commission published a draft amendment of the Toy Safety Directive laying out specific limit values for aniline
• The EU Commission published a draft amendment - adding three new entries to the list of prohibited allergenic fragrances
• The EU Commission published a draft amendment - adding sixty-one new entries to the list of allergenic fragrances
• Ukrainian updated toy regulation in line with Directive 2009/48/EC of the EU
• Four years since Turkey Adapted Toy Regulation
• Brazil Sets Deadlines for Compliance on Toy Regulation

On February 24, 2022, the Latin America and the Caribbean Circular Economy Coalition launched a document envisioning a stronger Circular Economy vision for the region. It intends to inspire governments, stakeholders, and initiatives towards a common goal of sustainable economic development based on circularity.

The Circular Economy in Latin America and the Caribbean: a shared vision considers the regional characteristics when proposing transitional activities from a linear economy to a circular one. The initiative is spurred on by the growing global drive to pursue long-term economic prosperity.

Just after a year of its launch (February 2021), the Latin America and the Caribbean Circular Economy Coalition has brought together dozens of government officials, representatives from relevant international institutions, businesses, and academia to accelerate the transition to a circular economy and imagine the future of the region based on a circular economy functioning at scale.

The document is believed to facilitate dialogue, engagement, and exchange, resulting in

·       alignment of policies from developing common standards to developing international policies such as trade and in turn enhance development opportunities

·       interoperability of policy and business schemes, for example by aligning on the collection and sorting schemes to sharing a classification or taxonomy scheme.

·       help nurture an inclusive and just transition within countries and regions, for example through the exchange of best practices and understanding of investment needs.

The document is available in English, Spanish, and Portuguese.

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 improve their chemicals management and more specifically, improve their national implementation of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Launched on April 4, 2022, this project is a collaboration between the European Union, the Strategic Approach to International Chemicals Management (SAICM), the International Council of Chemical Associations (ICCA), UN Environment Programme (UNEP), the European Chemicals Agency (ECHA), and the UN Institute for Training and Research (UNITAR), who will all work as partners with each concerned country’s government.

The implementation of GHS is a long process that needs several years to be put in place and the next four years will be used for this pilot project. According to Marco Mensink, the Council Secretary of ICCA, the pilot project will test and evaluate the benefits of a long-term approach in supporting countries through the implementation and adoption process.

The key activities of the project include setting the legislation for GHS implementation, required training and guidance as well as the needed tools for implementation. In Africa, only three countries have implemented GHS so far and these countries are Mauritius, South Africa, and Zambia.

Also, Rwanda recently started the process to implement GHS. A notification of the draft standard was sent to WTO and the feedback was opened till March 17, 2022. The draft first edition can be viewed here.

The "Study on industry involvement in the integrated approach to financing the sound management of chemicals and waste" is the most recent report elaborated by the Strategic Approach to International Chemicals Management (SAICM) to capture a complete description of industry activities towards an integrated approach to sound management of chemicals.

The report, published in April 2022, builds the context and recommendations to inform stakeholders to have the fifth session of the International Conference on Chemicals Management (ICCM) in mind. The session was expected to be held by July 2021 but was postponed until further notice due to the COVID-19 crisis.

The document further communicates identified flaws in the industry involvement, such as the lack of clarity defining what constitutes industry involvement and the absence of a mechanism for monitoring progress. In addition, there are difficulties in implementing the polluter pay principle, the development of legislation, and a subsequent funding deficit compose the landscape.

That said, the report brings options for action at various levels and a variety of actors, aiming to help raise financing along value chains and accelerate the transformation of economic models and industrial practices to internalize the cost associated with chemicals.

The next ICCM meeting will consider these points in the discussion to adopt new instruments and modern chemical frameworks for the sound management of chemicals.

At the United Nations Triple Conferences of the Parties to the Basel, Rotterdam, and Stockholm Conventions (BRS COPs) held from June 6 to 17, 2022, the parties agreed to ban perfluorohexane sulfonic acid (PFHxS).

PFHxS is a persistent organic pollutant (POP), a toxic chemical that poses risk to human health and the environment. All UN countries agreed to ban PFHxS globally and it has been added to Annex A of the Stockholm Convention on POPs.

PFHxS is an industrial chemical used in firefighting foams and in manufacturing stain coatings for carpets, paper, and cloth. It has over the years raised concern due to its persistence in the environment and in water. Under the Stockholm Convention, there are currently 30 POPs which deal with hundreds of chemicals and countries need to take action to stamp them out.

According to Ecetoc, an expert group from the industry research organization, the lack of mechanistic data on endocrine pathways in invertebrates is really challenging when using organisms for regulatory assessment of the environment for endocrine disrupting chemicals (EDCs).

Ecetoc showed their concerns on potential EDCs to enter into effective regulatory action while the fundamental knowledge of invertebrate endocriology was missing. The commonly used invertebrate toxicity tests could show adverse effects that might result from an endocrine mode of action without actually identifying the mechanisms lying within; in vivo and in vitro tools are lacking to determine the mechanisms.

A compiled list of endocrine-related molecular initiating events across different invertebrate groups is suggested as an urgent priority to develop Adverse Outcome Pathways (AOPs), which is also strongly believed to benefit the regulation of such substance use. The relevant regulation is currentl unavailable, and the expert group including industry scientists, Steve Dungey from the UK Environment Agency, and Adam Lillicrap from the Norwegian Institute for Water Research in Oslo, Norway, are calling for strong attention on this topic, which is likely to affect the future restriction policy-making on the chemicals that are involved.