What has happened with the Primo Max II manufacturing?
The active ingredient of Primo Maxx II, trinexepac-ethyl, has been manufactured with an incorrect co-formulant to that stipulated in the original registration. The co-formulant is almost identical to the intended one and the product passed all QC testing.
However, the incorrect co-formulant used is classified as flammable, and as such carries a different hazard warning to that on the original label.
What is the co-formulant, what is it used for?
This co-formulant is used in other formulations and it has similar properties to the correct co-formulant. Both act mainly as solvents to maintain stability of the formulation.
Syngenta and many other companies are using this solvent in other formulations. It is also widely used in consumer products, such as household cleaners and felt tip pens.
Are there different labelling implications for this product now?
The product with the incorrect co-formulant is flammable and the labelling must be changed accordingly.
Specific re-labelling guidance is available.
Given that the hazard classification has changed, do we need to store the product differently?
Yes, any remaining stock in store must be moved to a designated flammable secure area. Details of what this may entail are available from the Syngenta Turf website Primo Maxx II resource centre.
Does the affected Primo Maxx II have the same efficacy as promised in the promotional materials? Are there implications for turf safety or quality?
There have been no complaints regarding the use of this Primo Maxx II formulation from any country in Europe. In addition, over 20 trials have been conducted by researchers and contract trials organisations using this formulation of Primo Maxx II. In all cases the efficacy of the product has been to the high level expected and no turf safety concerns were identified. Primo Maxx II provided benefits in terms of turf color and quality as expected.
Does the non-approved co-formulant have concerns regarding safety to users or the environment? What is the safety profile of this co-formulant?
The co-formulant presents no concern for environmental safety and, when used according to the product label, no human safety concern is foreseen.
Who will manage the process of generating a new SDS and new labels for all the products in store?
A new SDS has been created for the off-specification product and can be downloaded from the Syngenta Turf website.
Additional labels to indicate that the product is flammable are required for product still held in store and can also be downloaded from the website Primo Maxx II resource centre.
What about other turf products from Syngenta, have you checked that they are compliant?
The problem is limited to Primo Maxx II from one manufacturing source. There are no concerns for other products from Syngenta.
What are the legal implications for anyone having used this product?
No issues are foreseen for anyone having used the product up to this point
It is important to note that once anyone has knowledge about the issue, the continued sale or use of the product must cease. Please do not use the product and await further instructions.
What happens next?
Full details of a five-step plan to resolve the issues with Primo Maxx II in customers’ stores is available of the Syngenta Turf website, with a dedicated Primo Maxx II resource centre including the latest available details.
If you have any further questions please email golf.syngenta@syngenta.com or contact your local ICL representative.