How are short fill products regulated?
General product safety is of fundamental importance to every business. In the worst case scenario, the very viability of a business can be at stake. The European Union has long had product-specific safety legislation. Since 1992 it has had more general safety legislation designed to “sweep-up” any products not otherwise caught by European safety legislation. The current legislation is the General Product Safety Directive (Council Directive 2001/95/EC of 3 December 2001) (OJ L 11/4 of 15 January 2002) which in the United Kingdom is implemented by the General Product Safety Regulations 2005 (SI 2005 No. 1803).
Other directives of the European Union regulate specific products. The General Product Safety legislation is different in that applies to all products unless “there are no [other] specific provisions governing the safety of the product” in European law.
The European Union Tobacco Products Directive 2014, enacted in the United Kingdom by the Tobacco and Related Products Regulations 2016 applies only to products which contain tobacco or nicotine no matter what the concentration of the tobacco or nicotine. The safety of a product which contains no tobacco or nicotine is therefore not governed by that legislation but by the General Product Safety Regulation. A so-called “short fill product” (nicotine-free flavoured e-liquid) is designed to be vaped in an e-cigarette even though it contains no nicotine. Accordingly, since it is not caught by the Tobacco and Related Products Regulations 2016, its advertisement and sale will be governed by the General Product Safety Regulation.
TPD regulation for short fills in selected European countries
In Greece, The Netherlands and Austria, zero-nicotine products are regulated through the TPD system. From January 2021, Germany will follow suit. In all these countries businesses can notify zero MG nicotine products in larger bottle sizes, except for The Netherlands, which still holds zero-MG to the 10ml bottle limit.
Safety under the General Product Safety Regulation
Under the General Product Safety Regulation a “safe product” has a complex definition. It is a product “which, under normal or reasonably foreseeable conditions of use … does not present any risk or only the minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons”. In determining that test the characteristics, presentation, labelling and any warnings or instructions on the product are all relevant. A further relevant factor is “the effect of the product on other products, where it is reasonably foreseeable that it will be used with other products”.
Where there is a European or national law or a standard governing the product, it can be presumed to be “safe”. If there are none, the safety should be determined having regard to, for example: the product safety codes of good practice in the sector concerned; the state of the art and technology; and reasonable consumer expectations concerning safety.
Applying these provisions to “short fill products” leads to the following relevant factors:
- Short fill products are widely advertised for use with separate nicotine shots. Since consumers look to use separate nicotine shots with a short fill product, this cannot be ignored when considering the safety of short fill products.
- While there are no standards applying to “short fill products” there are standards applying to usual e-cigarette liquid which are relevant ie. TPD and TRPR being “safety codes of good practice in the sector concerned”.
- The “reasonable expectations of consumers” would indicate that the standards for the usual e-cigarette liquids should be applied even for “short fill products”.
- Since the state of the art and technology easily allow the application of the standards for the usual e-cigarette liquids to be applied even for “short fill products”, that further indicates that they should be applied.
The only mitigating factor is that the nicotine shots are themselves a regulated tobacco product. Nevertheless, the bulk of these factors point towards the appliance of a high standard for e-cigarette liquids even for “short fill products”.
Of course the primary obligations to apply these standards is that of the “producer” of the product. In European law, this will be the manufacturer, or where the manufacturer is outside the European Union, the manufacturer’s representative. Where the manufacturer fails to appoint a representative, the importer becomes responsible as if it were the “producer”. The producer commits a criminal offence where it places an unsafe product on the market.
However, the distributor must not sell or advertise for sale a product which he knows or ought to have known is not a safe product. A distributor would be well advised to seek assurances from the manufacturer on these issues. The legislation is backed up by criminal law. Both a company and individual directors can suffer criminal penalties. The current maximum penalty is a fine of up to £20,000 and imprisonment for up to three months. The only defence available is that of “due diligence”. This applies only where the company or person who is prosecuted can show that he or she took all reasonable steps and exercised all due diligence to avoid committing the offence.
ADACT’s Chief Regulatory Officer, Damien Bové, said “The popular conception that “short fill products” are unregulated is false. Since “short-fill products” are not directly covered by any specific European Union legislation, such as the Tobacco Products Directive, their safety is governed by the General Product Safety Regulations. That requires a consideration of how they are advertised as well as the standards expected by consumers and the standards applicable to other products in the sector. These factors indicate that those affected by the legislation, including manufacturers and distributors should have regard to the Tobacco Products Directive, even though it only applies directly to products which actually contain tobacco.”