Regulatory testing for aerosol devices the manufacturer. ADD 75/324/EEC demands that the person responsible for marketing the aerosol dispenser has to cover “risks from inhalation of the spray under normal and reasonably foreseeable conditions of use, taking into account droplet size distribution as well as the chemical and physical properties of the contents.” Meanwhile, EC No 1223/2009 obliges the responsible person to analyze “the normal and reasonably foreseeable exposure routes.” However, while ADD and EC regulatory texts stipulate that assessing exposure by inhalation is a significant consideration to meeting requirements, both are noticeably vague in terms of the relevant aspects and guidance on how to perform hazard analysis/safety assessment. This, together with the variables and complexities involved with the aerosolization process, leave many spray developers uncertain as to how to best prove safety of use. With few defined or mandatory tests many spray developers turn to compiling extensive data sets that provide in-depth understanding of their products’ behaviors. Particle/ droplet sizing techniques are routinely employed for this purpose, providing manufacturers with understanding concerning performance and hazard analysis to support and strengthen REACH applications. Evaluating aerodynamic and light scattering sizing techniques For spray products, hazard assessment requires a review of all available toxicity data. This includes: • Acute systemic toxicity after oral, dermal or inhalation exposures • Irritation/corrosion (local), sensory (mucosal, dermal and/or inhalation) and pulmonary (deposition of inert materials) effects • Sensitization (skin and respiratory sensitizer) • Repeated dose toxicity • Mutagenic/carcinogenic data These hazards are then characterized in terms of the levels to which human exposure should be limited. This requires all possible systemic and local (respiratory tract) effects to be considered and determined. There are many publicly available exposure and hazard assessment models Dr. Anne Virden Product Technical Specialist-Diffraction Malvern Instruments The importance of particle size to spray hazard analysis Legislative changes in recent years concerning the safety and testing of spray products place increasing importance on fully understanding their characteristics and controlling the inhalation risks. Spray formulations are highly effective in the delivery of consumer products ranging from pharmaceutical inhalers to hair products and chemical detergents. The beneficial effects of these pharmaceutical preparations depend on users being able to inhale and deposit material of the correct size in the lungs to ensure therapeutic effects. The unintended inhalation of non-pharmaceutical sprays represents the other side of the coin, and it is essential to understand and minimize the risks. This presents manufacturers with a number of challenges, not least of which is reliable spray analysis. This article reviews the importance of particle size to spray hazard analysis and details the available techniques for measuring aerosol particle size, looking at the benefits and disadvantages of each and how the results compare. Techniques covered include time of flight spectroscopy, aerodynamic impaction and laser diffraction. Responding to REACH Recently, developments in regulatory procedures within Europe have significantly changed the way in which chemical products achieve market approval. Since 2007, any new chemical intended for manufacture or import in the European Union (EU) must be submitted to and approved by REACH, a regulatory body that covers the Registration, Evaluation, Authorization & Restriction of Chemicals. REACH has a broad jurisdiction within the EU, applying to practically all chemical substances imported or manufactured in quantities of one tonne or more per year, and its authority extends to all aerosolized products. The intent of the REACH initiative is to fully transfer the burden of hazard and safety analysis from third party regulatory bodies to those that manufacture and market chemicals. For instance, the Aerosol Dispersers Directive (ADD) 75/324/EEC and Cosmetic Products Regulation (EC) No. 1223/2009 are among the enhanced requirements to assess the toxicological hazards posed by spray products. Both of these place responsibility for hazard assessment with May 2014 Spray 41
SprayMay14
To see the actual publication please follow the link above