Butylparaben included in ECHA’s SVHC Candidate List
The European Chemicals Agency (ECHA) has updated its Candidate List of Substances of Very High Concern (SVHCs) and included 4 new substances – three that are toxic to reproduction and one endocrine disruptor – Butylparaben, used as preservative in cosmetic products. Now, this list contains 209 substances that may have serious adverse effects on people or the environment.

BUTYLPARABEN AS COSMETIC INGREDIENT

In cosmetics and personal care products, Butylparaben is used as a preservative and masking agent. According to the European Cosmetic Regulation No. 1223/2009, Butylparaben is included in the list of preservatives allowed in cosmetic products (Annex V to Regulation), subject to the restrictions laid down. Butylparaben may be used as a preservative in cosmetics at a maximum concentration of 0.14% (as acid) in ready for use preparation. The use of this ingredient is not allowed in leave-on products designed for application on the nappy area of children under three years of age.

In 2011, the European Commission’s Scientific Committee on Consumer Safety (SCCS) issued an opinion on Parabens. The SCCS was of the opinion that the use of Butylparaben and Propylparaben as preservatives in finished products was safe to the consumer, as long as the sum of their individual concentrations did not exceed 0.19%.

In 2019, the Cosmetic Ingredient Review (CIR) Expert Panel has assessed the safety of Parabens in cosmetic products, including Butylparaben, and concluded that they were safe (except Benzylparaben) as cosmetic ingredients in the present practices of use and concentration described in the safety assessment report and when the sum of the total parabens in any given formulation does not exceed 0.8%.

ECHA and SVHCs

The European Chemicals Agency (ECHA) Candidate List of Substances of Very High Concern (SVHCs) has been updated with 4 new substances and now contains 209 substances that may have serious effects on people or the environment. Most of the compounds present in the Candidate List of SVHCs are carcinogenic, mutagenic or toxic to reproduction.

1-Vinylimi­dazole, 2-Methylim­idazole and Dibutylb­is(pentane-2,4-dionato-O,O’)tin, used in industrial processes to produce polymers, were included in the list due to reprotoxic effects;

Butylparaben was included due to its endocrine-disrupting properties, which can be hazardous to human health.

Since the date of the substances inclusion in the Candidate List of SVHCs (June 25, 2020), producers and importers of articles or products including these substances have six months to notify ECHA. From January 2021, it will be mandatory for companies to notify the Agency, via ECHA’s upcoming SCIP database if their articles or products contain substances of concern from this list at levels above 0.1% weight by weight (w/w). On addition, sufficient information to costumers and consumers must be provided by a supplier of articles or products containing a Candidate List substance above 0.1% w/w to allow safe use.

As advised by ECHA, companies are urged to check their legal obligations relating to the safe use of these substances and to seek substitution of substances included in the SVHC Candidate List by safer alternatives.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
  2. Scientific Committee on Consumer Safety (SCCS) – Opinion on Parabens, COLIPA nº P82, 2011
  3. Scientific Committee on Consumer Safety (SCCS) – Opinion on Parabens – Updated request for a scientific opinion on propyl- and butylparaben, 2013
  4. Cosmetic Ingredient Review (CIR) Expert Panel – Amended Safety Assessment of Parabens as Used in Cosmetics, 2019
  5. European Chemicals Agency (ECHA) – Candidate List update: Four new hazardous chemicals to be phased out (ECHA/PR/20/05)
  6. European Chemicals Agency (ECHA) – Candidate List of substances of very high concern for Authorisation (published in accordance with Article 59(10) of the REACH Regulation)

further
reading

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 »
cosmetic products

European Commission Recommendation on the Definition of Nanomaterial

Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. The European Commission has published a new Recommendation to clarify the definition of ‘nanomaterial’. This definition may serve different policy, legislative and research purposes when addressing materials or issues concerning products of nanotechnologies.

Read More »
cosmetic products

Expected Restriction on the Use of Methyl Salicylate

The European Commission has notified the World Trade Organization (WTO) of a draft amendment to the Regulation (EC) No. 1223/2009 on cosmetic products. Annex III to Regulation will be amended, and the use of Methyl Salicylate in cosmetic products will be restricted.

Read More »
cosmetic products

Environmental Labelling of Cosmetic Products in Italy and France

Although the European Cosmetics Regulation is applicable to every cosmetic product made available in the European Union market, some national legislations may also apply. Environmental regulations in Italy and France specify mandatory labelling requirements applicable to products marketed in these countries.

Read More »