Following the new EU Regulation 605-2014 (CLP Regulation), changes were made to the harmonised classification and labelling of certain substances listed in Annex VI to the CLP Regulation. A number of pejorative classification changes may be mentioned, for example:
Ø Formaldehyde: from carc. Cat. 3 R40 to carc. Cat. 2 R45 (H350) and is also classified as a mutagen cat. 3 R68 (H341);
Ø Styrene: the classification is added as Repr. Cat. 3 R63 (H361d), and STOT RE 1 (H372) for the auditory organs.
As to the safety implications, note that the change of classification for formaldehyde significantly alters the regulatory framework for companies that handle this substance. More particularly, the substance falls within the scope of Title IX of Legislative Decree 81/08 Chapter II for carcinogens and mutagens, with additional obligations for the Employer, including:
Ø Obligation to replace the agent where technically possible, or alternatively the obligation to put in place a closed-loop system, or alternatively to reduce the number of exposed workers to a minimum
Ø Obligation to update the risk assessment for the risk in question, at least every 3 years (including data on the investigations carried out on the number of workers exposed…)
Ø Obligation to implement the industrial hygiene examination (art. 237 subsection 1 letter d)
Ø Obligation to provide targeted mandatory training at least every 5 years
Ø Obligation to draw up and notify the Register of Exposed Workers to the Local Health Authority (ASL) every 3 years
Ø obligation to provide locker rooms with lockers that contain separate compartments where the worker can separate normal clothes from work clothes/PPE
Ø Obligation to perform special health surveillance
Ø Obligation to notify supervisory bodies in the event of unforeseeable exposure or accident
Note also that depending on concentration levels, mixtures with formaldehyde may also be Toxic (R23/24/25), and this also has implications for the applicability of Legislative Decree No. 334/99, as amended.
It should also be noted that formaldehyde is not found exclusively in the form of a product or mixture (e.g. applications in pathological anatomy, disinfection): most formaldehyde produced is used to produce polymers and other chemical compounds, e.g. thermosetting resins, plastic laminates, insulating foams, adhesives, polyoils; with urea it is used as a bonding paint for wooden laminated chipboard or MDF; it is also contained in the sound-absorption panels of false ceilings and in the partition walls of open space offices. It also used in textile dyes.
In all these applications, therefore, there is a risk that this substance may be released into the work environment, particularly where high-temperature processes are underway.
The classification of Formaldehyde as “carcinogenic, 1/B”, which was to enter into force from 1 April 2015, has been postponed until 1 January 2016.
The updating of the Risk Assessment Document must therefore be postponed until this date.
Where workers are exposed (laboratories, health, industry, cosmetics) the following obligations are therefore extended until 01.01.2016:
Employer: to adjust the risk assessment document to the application of the provisions of Title IX – Chapter II of Legislative Decree 81/08;
in the event of exposure, the following obligations apply: to maintain the Register of workers exposed to carcinogens, to ensure health surveillance, to collaborate in the training of workers and selecting PPE, to organise a heath inspection when the employment relationship has ended, to transmit the medical health and risk file to the National Institute for Insurance against Occupational Accidents (INAIL, formerly the ISPESL) in the event of termination, to request the medical health file from ISPESL (if the employee does not have a copy) when commencing employment, etc.