Single-use Plastic and Microplastics Regulations
The cosmetics and personal care products industry is growing, but with this growth comes a major concern: plastics pollution. The European Commission has published the Directive (EU) 2019/904, known as Single-Use Plastic Directive, which addresses the reduction of the impact of certain plastic products on the environment. In line with what is happening in the EU, different countries around the globe are following the same path.

SINGLE-USE PLASTIC AND DIRECTIVE (EU) 2019/904

Single-use plastic (plastic bags and microbeads) are a considerable cause of marine plastic pollution. Since the 1970s, plastics have been reported as potentially harmful for the marine environment. Nowadays, marine plastic pollution has become a significant environmental concern not only for scientists and non-governmental organizations, but also for government officials and the general public.

According to ECHA (European Chemicals Agency), microplastics “are very small particles of plastic material (typically smaller than 5mm and often much smaller including nano plastics)”. They can unintentionally be formed through the wear and tear of larger pieces of plastic or manufactured and intentionally added to products. We can find microplastic particles in a wide range of products available in the European market, like cosmetics, detergents, cleaning products and paints. Some plastics contain hazardous chemicals (e.g., bisphenol A, phthalates) that can have a negative impact on nature and human health. Microbeads (microplastics) are commonly used in cosmetics as an exfoliating or scrubbing agent, particularly in products such as facial cleansers and scrubs, shower gels and toothpastes.

Microbeads are not biodegradable and can persist for long periods of time in the environment. They can be ingested by living animals in the polluted environment. They are not toxic or irritating to humans, but can represent a human health hazard due to their bioaccumulation in marine organisms that are consumed by people.

In response to this global problem, the European Union has issued the Directive (EU) 2019/904 (on the reduction of the impact of certain products on the environment), commonly known as Single-Use Plastic Directive. The main objectives of this Directive are “to prevent and reduce the impact of certain plastic products on the environment, in particular the aquatic environment, and on human health, as well as to promote the transition to a circular economy with innovative and sustainable business models, products and materials, thus also contributing to the efficient functioning of the internal market”. The main products referred in the Directive are food containers, cups for beverages, cutlery, plates, straws, cotton bud sticks, and other products, including plastic materials used in cosmetics (you can find more information on our previous post).

Marking requirements referred in Article 7 of the Directive are particularly relevant to cosmetics and personal care products. Article 7 states that “each single-use plastic product listed in Part D of the Annex placed on the market bears a conspicuous, clearly legible and indelible marking on its packaging or on the product itself informing consumers” (about the presence of plastic in products and its negative impact and appropriate waste management). Placing cosmetic products made of oxo-degradable plastic in the EU market is prohibited. Furthermore, wet wipes need to follow the marking specifications set out in the Commission Implementing Regulation (EU) 2020/2151.

ECHA has already proposed in 2019 a wide-ranging restriction on intentional uses of microplastics placed on the EU/EEA market (consumer or professional use products) to avoid or reduce their release to the environment. This restriction proposal was developed in the context of the EU Plastics Strategy, which “aims at circular economy and contributes to reaching in 2030 sustainable development goals, the global climate commitments and the EU’s industrial policy objectives”.

ECHA’s Committee for Risk Assessment (RAC) supported the proposed restriction for microplastics and further recommended more stringent criteria for biodegradable polymers. The European Parliament final validation is expected in the first half of 2022 and transition periods will be granted, according to the type of product: rinse-off products, leave-on products, make up products, nail polishers and lipsticks. This last group of products is considered to have lower environmental impact, so a longer transition period is expected to be granted.

EU MEMBER STATES REGULATIONS ON MICROPLASTICS

Microbeads in products intended to be rinsed-off are a major concern due to their impact in the environment. Several EU Member States, have legislated in order to restrict/prohibit some types of microplastics in cosmetics (like microbeads). In response, cosmetic companies are are increasingly using natural alternatives.

According to the Portuguese Constitution, “everyone has the right to a humane, healthy and ecologically balanced living environment and the duty to defend it” (Article 66). It is up to the State to ensure the right to the environment, within the framework of sustainable development, through organizations and with the involvement and participation of citizens. Regulation regarding plastic waste management has been enacted by the Portuguese government in recent years.

In line on what is happening in other EU and third countries, Portugal is also starting to implement restrictions in the use of microplastics in cosmetics and other products. The Council of Ministers has already approved a new decree-law that prohibits placing cosmetic products and detergents that contain plastic microspheres intentionally added in a concentration equal to or greater than 0.01% by weight on the market.

The Netherlands was the first country to introduce a ban on the import, manufacture and sale of microbeads in cosmetic products (2014). In 2017, a decree was published in France, banning the use of solid plastic particles (microbeads) in rinse-off exfoliating and cleaning cosmetic products from 2018 onwards. Since 2020, plastic cotton buds are also prohibited.

In Sweden, a ban on the sale of cosmetic products containing plastic microbeads in cosmetic products which are rinsed-off or spat out after use on skin, hair, mucous membranes or teeth (e.g., body scrubs, shower soap, shampoo, conditioner and toothpaste), came into force in 2018. The regulation applies to plastic microbeads in solid phased with a size of less than 5 millimeters (in any dimension, including nano size) and that are insoluble in water. Nevertheless, if products are manufactures using naturally occurring polymers as raw material that quickly degrade into monomers in an aquatic environment and pose no risk of harm to aquatic organisms, they may be granted an exception.

GLOBAL PERSPECTIVE ON MICROPLASTICS USE

In 2018, the ban on the manufacture of products containing microbeads came into force in the United Kingdom (UK). Since then, plastic microbeads can no longer be used in rinse-off cosmetic and personal care products.

This type of restrictions and prohibitions are not only happening in the Europe. In fact, in 2020, China prohibited the use of microbeads in cosmetics and personal care products (see previous post). In 2017, China’s former Ministry of Environmental Protection (now Ministry of Ecology and Environment), listed microbeads as products with a high pollution and high environmental risk. On January 2020, China’s NDRC (National Development and Reform Commission) and the Ministry of Ecology and Environment issued Notice No. 80 “Opinions on Further Strengthening the Control of Plastic Pollution”, with the aim of prohibiting the use of microbeads in cosmetics and personal care products. The ban applies to rinse-off products intended for scrubbing, exfoliating, and other purposes (e.g. shampoo, shower gel, scrubs, cleansers, etc.) and also to toothpastes and tooth powders containing intentionally added plastic particles with a size inferior to 5 millimeters.

In the United States, the Microbead-Free Waters Act of 2015 prohibits the manufacturing, packaging, and distribution of rinse-off cosmetic products that contain plastic microbeads (intentionally added). This Act also applies to products that are both cosmetics and Over-The-Counter (OTC) drugs (e.g., toothpastes). According to this regulation, plastic microbead is defined as “any solid plastic particle that is 5 millimeters, or less, in size, and is intended to be used to exfoliate or cleanse the body or any part of the body“.

In 2015, microbeads (defined as plastic microbeads that are equal to or less than 5 millimeters in size) were added to Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA). Regulations therefore prohibit the manufacture, import and sale of toiletries that contain plastic microbeads, including cosmetics, non-prescription drugs and natural health products. Microbeads in Toiletries Regulations came into force in 2018.

If you have any doubts on how these regulatory and legislative changes affect your cosmetic products, please feel free to contact us at info@criticalcatalyst.com.

References:

  1. Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment – https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019L0904&from=EN
  2. Scientific committees: EU-wide restriction best way to reduce microplastic pollution. ECHA/PR/20/09. European Chemicals Agency (ECHA). Available from: https://echa.europa.eu/pt/-/scientific-committees-eu-wide-restriction-best-way-to-reduce-microplastic-pollution
  3. World leading microbeads ban comes into force. Press release. Department for Environment, Food & Rural Affairs and the Rt Hon Michael Gove Mp. 2018. Available from: https://www.gov.uk/government/news/world-leading-microbeads-ban-comes-into-force
  4. Governo aprova restrições para detergentes e cosméticos com microplásticos. SIC Noticias. Available from: https://sicnoticias.pt/economia/2021-07-15-Governo-aprova-restricoes-para-detergentes-e-cosmeticos-com-microplasticos-45892180

further
reading

medical devices

Amendments to the Transitional Provisions of the European Union MDR and IVDR

The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

Read More »
medical devices

EU MDR – Proposal for Extension of Transition Period

The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.

Read More »
medical devices

MDCG 2022-18 – EU MDR Article 97

EU MDR Article 97 may be a temporary solution to avoid disruption of supply of Medical Devices on the EU Market. The MDCG 2022-18 presents a uniform approach for application of MDR Article 97 on non-compliant legacy devices under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.

Read More »
parfum_fragrance_allergen_1
cosmetic products

EU to set Labelling Requirements for 56 additional Fragrance Allergens in Cosmetic Products

World Trade Organization (WTO) has been notified by the European Commission of a draft amendment to Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in Cosmetic Products. The proposed date of adoption of the new regulation is expected to be in the first half of 2023 and the propose date of entry in force 20 days from the publication in the Official Journal of the European Union.

Read More »
cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »
medical devices

EUDAMED – harmonized practices and alternative solutions for IVDR until the database is fully functional

EUDAMED is one of the key aspects of the new rules on in vitro diagnostic medical devices – Regulation (EU) 2017/746. However, it is only expected to achieve full functionality by the second quarter of 2024. Until then, how is the information submitted and/or exchanged between manufacturers, notified bodies and competent authorities?

Read More »
medical devices

EUDAMED – update on timelines

EUDAMED is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), and it is expected to achieve full functionality by the second quarter of 2024.

Read More »
cosmetic products

UK OPSS call for data on six cosmetic ingredients

On 14 July 2022, the Office for Product Safety and Standards (OPSS – the UK regulator for cosmetic products) issued a call for data on the safety of the following six cosmetic ingredients to investigate any suspected endocrine disrupting properties. 

Read More »